According to a report of The Lancet, Oxford-AstraZeneca COVID-19 vaccine is safe and effective, giving good protection. But experts say this confirmation does little for regulatory bodies who are yet to approve vaccine.

The Lancet: Oxford-Astrazeneca COVID-19 vaccine is 'safe and effective'

Indian Pharmaceuticals firm Bharat Biotech is seeking emergency authorisation of its Coronavirus vaccine 'Covaxin'. This comes after Pfizer & Serum institute producing AstraZeneca vaccine have applied for the emergency use authorisation from DGCI.

India: Bharat Biotech latest to seek emergency use authorisation

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. 
 
Also read | <a href="https://www.wionews.com/science/is-natural-immunity-from-covid-better-than-a-vaccine-347985">Is ‘natural immunity’ from COVID better than a vaccine?</a>

In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. 
 
<a href="https://www.wionews.com/india-news/serum-institute-of-india-applies-for-emergency-use-authorisation-for-oxford-vaccine-348006">Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine</a> 
 
The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. 
 
Also read | <a href="https://www.wionews.com/world/chinas-sinovac-secures-515-million-to-boost-covid-vaccine-production-347999">China's Sinovac secures $515 million to boost covid vaccine production</a>&nbsp;

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.

(With inputs from agencies)

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate.

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate. Also read | Is ‘natural immunity’ from COVID better than a vaccine? In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin. Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials. Also read | China's Sinovac secures $515 million to boost covid vaccine production An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. (With inputs from agencies)

Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine; expert panel to review

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>.

The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their "invaluable support".

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As promised, before the end of 2020, <a href="https://twitter.com/SerumInstIndia?ref_src=twsrc%5Etfw">@SerumInstIndia</a> has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri <a href="https://twitter.com/narendramodi?ref_src=twsrc%5Etfw">@narendramodi</a> ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) <a href="https://twitter.com/adarpoonawalla/status/1335810817841717249?ref_src=twsrc%5Etfw">December 7, 2020</a></blockquote>
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The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country.&nbsp;

Also read | <a href="https://www.wionews.com/science/is-natural-immunity-from-covid-better-than-a-vaccine-347985">Is ‘natural immunity’ from COVID better than a vaccine?</a>

The official sources told news agency PTI, SII's application mentioned data from four clinical studies, two in the UK and one each in Brazil and India, and said that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 cases.&nbsp;

Also read | <a href="https://www.wionews.com/world/chinas-sinovac-secures-515-million-to-boost-covid-vaccine-production-347999">China's Sinovac secures $515 million to boost covid vaccine production</a>&nbsp;

"In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae," said a source.&nbsp;

"Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield."&nbsp;

For a quick roll out of the vaccine, SII, world's largest vaccine manufacturer, entered into a collaboration with the University of Oxford and AstraZeneca to produce the drug and has already produced 40 million doses of the drug.&nbsp;

 
&nbsp;

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine.

The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine. The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their "invaluable support". As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support. — Adar Poonawalla (@adarpoonawalla) December 7, 2020 × The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country. Also read | Is ‘natural immunity’ from COVID better than a vaccine? The official sources told news agency PTI, SII's application mentioned data from four clinical studies, two in the UK and one each in Brazil and India, and said that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 cases. Also read | China's Sinovac secures $515 million to boost covid vaccine production "In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae," said a source. "Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield." For a quick roll out of the vaccine, SII, world's largest vaccine manufacturer, entered into a collaboration with the University of Oxford and AstraZeneca to produce the drug and has already produced 40 million doses of the drug.

Serum Institute of India applies for emergency use authorisation for Oxford vaccine

South Korea has reached a deal with AstraZeneca PLC to purchase its coronavirus vaccine candidate as it seeks to secure supplies amid a resurgence of outbreaks.

The government has said it was in final talks with global drugmakers including AstraZeneca, Pfizer Inc and Johnson &amp; Johnson over their experimental vaccines, and launched a preliminary review of the former's product in October for potential fast-track approval.

The JoongAng Ilbo newspaper said health authorities signed a contract with the Britain-based company on November 27, and were nearing agreements with Pfizer and Johnson &amp; Johnson.

"The AstraZeneca deal has been done, and a memorandum of understanding was reached with both Pfizer and Johnson &amp; Johnson. But further negotiations are needed to finalise the amount of supplies and the timing of shipment," the official was quoted as saying.

The Yonhap news agency also reported that an agreement with AstraZeneca was inked recently and the government would make an announcement as early as next week after completing negotiations with other firms.

The Korea Disease Control and Prevention Agency (KDCA) said that the JoongAng report was not the government's official position but that it would finalise talks and unveil comprehensive results shortly.

The KDCA has said 172 billion won ($157 million) was set aside to buy an initial 60 million doses this year, enough to vaccinate about 60% of the country`s population of 52 million, around the second quarter of 2021. It has secured 20 million doses via the COVAX facility, an international COVID-19 vaccine allocation platform co-led by the WHO.&nbsp;

(with inputs)

South Korea has reached a deal with AstraZeneca PLC to purchase its coronavirus vaccine candidate as it seeks to secure supplies amid a resurgence of outbreaks. The government has said it was in final talks with global drugmakers including AstraZeneca, Pfizer Inc and Johnson & Johnson over their experimental vaccines, and launched a preliminary review of the former's product in October for potential fast-track approval.

South Korea has reached a deal with AstraZeneca PLC to purchase its coronavirus vaccine candidate as it seeks to secure supplies amid a resurgence of outbreaks. The government has said it was in final talks with global drugmakers including AstraZeneca, Pfizer Inc and Johnson & Johnson over their experimental vaccines, and launched a preliminary review of the former's product in October for potential fast-track approval. The JoongAng Ilbo newspaper said health authorities signed a contract with the Britain-based company on November 27, and were nearing agreements with Pfizer and Johnson & Johnson. "The AstraZeneca deal has been done, and a memorandum of understanding was reached with both Pfizer and Johnson & Johnson. But further negotiations are needed to finalise the amount of supplies and the timing of shipment," the official was quoted as saying. The Yonhap news agency also reported that an agreement with AstraZeneca was inked recently and the government would make an announcement as early as next week after completing negotiations with other firms. The Korea Disease Control and Prevention Agency (KDCA) said that the JoongAng report was not the government's official position but that it would finalise talks and unveil comprehensive results shortly. The KDCA has said 172 billion won ($157 million) was set aside to buy an initial 60 million doses this year, enough to vaccinate about 60% of the country`s population of 52 million, around the second quarter of 2021. It has secured 20 million doses via the COVAX facility, an international COVID-19 vaccine allocation platform co-led by the WHO. (with inputs)

South Korea reaches deal to buy AstraZeneca's COVID-19 vaccine candidate

The Serum Institute of India, world's largest vaccine manufacturer, reiterated that the vaccine developed by AstraZeneca and Oxford university was safe and immunogenic.

India's Serum institute reiterates safety of AstraZeneca vaccine for COVID-19

Serum Institute of India, the world's largest vaccine manufacturer, on Tuesday denied allegations that a COVID-19 trial volunteer suffered serious side effects from a <a href="https://www.wionews.com/world/in-europe-before-the-end-of-2020-pfizer-biontech-files-for-eu-approval-of-coronavirus-vaccine-346707">vaccine</a> developed by AstraZeneca and Oxford University, saying that the vaccine is safe and immunogenic.

"We would want to assure everyone that the <a href="https://www.wionews.com/world/us-predicts-availability-of-covid-19-vaccines-before-christmas-346646">vaccine</a> won't be released for mass use unless it is proven immunogenic, and safe," it said in a blog.

Last week, a volunteer in Chennai claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot and has sued the company along with others and a sought compensation of Rs 5 crore.

"The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition," the Pune-based institute said.

Serum is conducting trials of AstraZeneca's vaccine in India as part of a manufacturing agreement. 
"Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned," Serum said.

It said all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly.

"The concerned authorities were informed and the principal investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. 
"Post which, we submitted all the reports and data related to the incident to the DCGI (Drugs Controller General of India). It is only after we cleared all the required processes that we continued with the trials," it added.

In response to claims made by the volunteer, Serum had on Sunday stated that the allegations were "malicious and misconceived".

Serum Institute of India, the world's largest vaccine manufacturer, on Tuesday denied allegations that a COVID-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and Oxford University, saying that the vaccine is safe and immunogenic.

Serum Institute of India, the world's largest vaccine manufacturer, on Tuesday denied allegations that a COVID-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and Oxford University, saying that the vaccine is safe and immunogenic. "We would want to assure everyone that the vaccine won't be released for mass use unless it is proven immunogenic, and safe," it said in a blog. Last week, a volunteer in Chennai claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot and has sued the company along with others and a sought compensation of Rs 5 crore. "The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition," the Pune-based institute said. Serum is conducting trials of AstraZeneca's vaccine in India as part of a manufacturing agreement. "Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned," Serum said. It said all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. "The concerned authorities were informed and the principal investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. "Post which, we submitted all the reports and data related to the incident to the DCGI (Drugs Controller General of India). It is only after we cleared all the required processes that we continued with the trials," it added. In response to claims made by the volunteer, Serum had on Sunday stated that the allegations were "malicious and misconceived".

AstraZeneca vaccine safe and immunogenic: Serum Institute of India

The Indian Council of Medical Research (ICMR) is conducting an inquiry into a reaction to AstraZeneca’s COVID-19 vaccine trial.

A senior official at AstraZeneca told Reuters on Sunday that even after the adverse effects, there is no reason to halt the trials.

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According to to Reuters, a 40-year-old man had suffered serious “neurological and psychological” symptoms after taking the shot, which is being given to participants in the Serum Institute of India.

"There was no immediate cause of concern at this stage," Samiran Panda, head of Epidemiology and Communicable Diseases at the ICMR, said while talking to Reuters.

Also read:&nbsp;<a href="http://13.235.153.162/world/sputnik-v-can-boost-efficacy-of-astrazeneca-vaccine-russian-research-centre-345769" hreflang="en">Sputnik V can boost efficacy of AstraZeneca vaccine: Russian research centre</a>

"It doesn't mean that long term assessment will not happen, it is still happening. I am aware of the activity," Panda said.

AstraZeneca has not put a statement addressing the reaction so far. The volunteer is seeking 50 million rupees ($676,288) in compensation and is also demanding the suspension of testing, and distribution of the vaccine.

Also read:&nbsp;<a href="http://13.235.153.162/world/oxfordastrazeneca-coronavirus-vaccine-to-undergo-new-global-trials-345677" hreflang="en">Oxford/AstraZeneca coronavirus vaccine to undergo new global trials</a>

"While the Serum Institute of India is sympathetic with the volunteer's medical condition, there's absolutely no correlation with the vaccine trial," the institute said.

"(The) volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent," it added.

The Indian Council of Medical Research (ICMR) is conducting an inquiry into a reaction to AstraZeneca’s COVID-19 vaccine trial. A senior official at AstraZeneca told Reuters on Sunday that even after the adverse effects, there is no reason to halt the trials.

The Indian Council of Medical Research (ICMR) is conducting an inquiry into a reaction to AstraZeneca’s COVID-19 vaccine trial. A senior official at AstraZeneca told Reuters on Sunday that even after the adverse effects, there is no reason to halt the trials. According to to Reuters, a 40-year-old man had suffered serious “neurological and psychological” symptoms after taking the shot, which is being given to participants in the Serum Institute of India. "There was no immediate cause of concern at this stage," Samiran Panda, head of Epidemiology and Communicable Diseases at the ICMR, said while talking to Reuters. Also read: Sputnik V can boost efficacy of AstraZeneca vaccine: Russian research centre "It doesn't mean that long term assessment will not happen, it is still happening. I am aware of the activity," Panda said. AstraZeneca has not put a statement addressing the reaction so far. The volunteer is seeking 50 million rupees ($676,288) in compensation and is also demanding the suspension of testing, and distribution of the vaccine. Also read: Oxford/AstraZeneca coronavirus vaccine to undergo new global trials "While the Serum Institute of India is sympathetic with the volunteer's medical condition, there's absolutely no correlation with the vaccine trial," the institute said. "(The) volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent," it added.

India: AstraZeneca vaccine causes adverse reaction in volunteer, inquiry underway

UK has asked it's independent regulator to assess Astrazeneca vaccine for possible rollout. WION brings you a report.

UK regulatory to study Aztrazeneca vaccine

As COVID19 vaccine trials has raised hopes for the World, crippled by a virus. But even after showing 90% efficacy in late trials, the British drug maker likely to run an additional global trial to excess the efficacy of its COVID 19 vaccine. The update comes from Astrazeneca's chief executive Pascal Soriot.

News global trials of Astrazeneca vaccine

The <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a> developed by Oxford University and AstraZeneca will undergo a new global trial as questions remain of the claims whether it could protect up to 90 per cent of people.&nbsp;

Sir John Bell, Oxford’s regius professor of medicine and the UK government’s life sciences adviser, on Thursday, rejected claims that the previous trial had not been properly conducted.&nbsp;

Also read | <a href="wionews.com/world/90-efficacy-of-oxfords-coronavirus-vaccine-came-from-younger-group-345535">90% efficacy of Oxford's coronavirus vaccine came from younger group</a>

"We weren't cooking this up as we went along," the Oxford University professor said, adding that the full, peer-reviewed data would likely be published in the Lancet medical journal this weekend.

Also read | <a href="https://www.wionews.com/world/light-at-the-end-of-the-tunnel-european-commission-president-ursula-von-der-leyen-says-first-european-citizen-might-be-vaccinated-before-end-december-345336">'Light at the end of the tunnel': European Commission president Ursula von der Leyen says first European citizen might be vaccinated before end December</a>

Meanwhile, the UK government has asked its independent drugs regulator to study the Oxford/ Astrazeneca vaccine as part of the formal approval process. &nbsp;&nbsp;

"We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards," said Health Secretary Matt Hancock, as reported by news agency AFP.&nbsp;

The vaccine has completed Phase III clinical trials, the final stage to detect the efficacy of any drug.&nbsp;

Data so far has shown that the vaccine has an average effectiveness of about 70 per cent.&nbsp;

On Friday, the shares of the drug dropped despite it requiring normal temperatures for storage and likely to available in relatively cheap prices.&nbsp;

 
&nbsp;

The coronavirus vaccine developed by Oxford University and AstraZeneca will undergo a new global trial as questions remain of the claims whether it could protect up to 90 per cent of people.

The coronavirus vaccine developed by Oxford University and AstraZeneca will undergo a new global trial as questions remain of the claims whether it could protect up to 90 per cent of people. Sir John Bell, Oxford’s regius professor of medicine and the UK government’s life sciences adviser, on Thursday, rejected claims that the previous trial had not been properly conducted. Also read | 90% efficacy of Oxford's coronavirus vaccine came from younger group "We weren't cooking this up as we went along," the Oxford University professor said, adding that the full, peer-reviewed data would likely be published in the Lancet medical journal this weekend. Also read | 'Light at the end of the tunnel': European Commission president Ursula von der Leyen says first European citizen might be vaccinated before end December Meanwhile, the UK government has asked its independent drugs regulator to study the Oxford/ Astrazeneca vaccine as part of the formal approval process. "We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards," said Health Secretary Matt Hancock, as reported by news agency AFP. The vaccine has completed Phase III clinical trials, the final stage to detect the efficacy of any drug. Data so far has shown that the vaccine has an average effectiveness of about 70 per cent. On Friday, the shares of the drug dropped despite it requiring normal temperatures for storage and likely to available in relatively cheap prices.

Oxford/AstraZeneca coronavirus vaccine to undergo new global trials

Astra and its CEO are facing scrutiny as the drugmaker responds to growing confusion over the vaccine.

Astrazeneca likely to run additional global covid-19 vaccine trial

Among the many types of facemasks in use, such as cloth masks, surgical masks, and N95 masks, the study says only the latter can filter out aerosol-sized droplets.&nbsp;

The use of face masks to help slow the spread of COVID-19 has been widely recommended by health professionals. Face masks slow spread of COVID-19 and help to prevent the aftereffects of the deadly virus.

According to a review of studies, the COVID-19 pandemic could be stopped if at least 70 percent of the public wore face masks consistently.

The research, published in the journal Physics of Fluids, assessed studies on face masks and reviewed epidemiological reports on whether they reduce the number of people an infected person spreads the pathogen to — the reproduction number of the virus.

”The highly efficacious facemask, such as surgical masks with an estimated efficacy of around 70 percent, could lead to the eradication of the pandemic if at least 70 percent of the residents use such masks in public consistently,” the scientists, including Sanjay Kumar from the National University of Singapore, wrote in the study. ”Even less efficient cloth masks could also slow the spread if worn consistently,” Kumar added.

According to the scientists, one key aspect of face mask function involves the size of fluid droplets expelled from the nose and mouth when a person talks, sings, sneezes, coughs, or even simply breathes. They said larger droplets, with sizes around 5-10 microns, are the most common, adding that smaller droplets below 5 microns are possibly more dangerous. In comparison, the scientists said the human hair is about 70 microns in diameter.

Among the many types of facemasks in use, such as cloth masks, surgical masks, and N95 masks, they said only the latter can filter out aerosol-sized droplets. The performance of face masks worn for many hours, such as by health care or other essential workers, impact how effective overall mask-wearing can be, the researchers added. They found that face masks made of hybrid polymer materials could filter particles at high efficiency while simultaneously cooling the face since the fibres used in these allow heat to escape from beneath the mask.

”There could be some relation between breathing resistance and the flow resistance of the face mask which will need to be studied for a face mask-wearing interval,” said Heow Pueh Lee, another co-author of the study.

”Also, the environmental condition in the compartmental space within the face mask will need to be more accurately quantified using miniaturised sensors and the development of human replicas for such studies,” Lee said. Based on the analysis, the researchers underscored the importance of consistent use of efficient facemasks, such as surgical masks.

(With inputs from agencies)

Among the many types of facemasks in use, such as cloth masks, surgical masks, and N95 masks, the study says only the latter can filter out aerosol-sized droplets.

Among the many types of facemasks in use, such as cloth masks, surgical masks, and N95 masks, the study says only the latter can filter out aerosol-sized droplets. The use of face masks to help slow the spread of COVID-19 has been widely recommended by health professionals. Face masks slow spread of COVID-19 and help to prevent the aftereffects of the deadly virus. According to a review of studies, the COVID-19 pandemic could be stopped if at least 70 percent of the public wore face masks consistently. The research, published in the journal Physics of Fluids, assessed studies on face masks and reviewed epidemiological reports on whether they reduce the number of people an infected person spreads the pathogen to — the reproduction number of the virus. ”The highly efficacious facemask, such as surgical masks with an estimated efficacy of around 70 percent, could lead to the eradication of the pandemic if at least 70 percent of the residents use such masks in public consistently,” the scientists, including Sanjay Kumar from the National University of Singapore, wrote in the study. ”Even less efficient cloth masks could also slow the spread if worn consistently,” Kumar added. According to the scientists, one key aspect of face mask function involves the size of fluid droplets expelled from the nose and mouth when a person talks, sings, sneezes, coughs, or even simply breathes. They said larger droplets, with sizes around 5-10 microns, are the most common, adding that smaller droplets below 5 microns are possibly more dangerous. In comparison, the scientists said the human hair is about 70 microns in diameter. Among the many types of facemasks in use, such as cloth masks, surgical masks, and N95 masks, they said only the latter can filter out aerosol-sized droplets. The performance of face masks worn for many hours, such as by health care or other essential workers, impact how effective overall mask-wearing can be, the researchers added. They found that face masks made of hybrid polymer materials could filter particles at high efficiency while simultaneously cooling the face since the fibres used in these allow heat to escape from beneath the mask. ”There could be some relation between breathing resistance and the flow resistance of the face mask which will need to be studied for a face mask-wearing interval,” said Heow Pueh Lee, another co-author of the study. ”Also, the environmental condition in the compartmental space within the face mask will need to be more accurately quantified using miniaturised sensors and the development of human replicas for such studies,” Lee said. Based on the analysis, the researchers underscored the importance of consistent use of efficient facemasks, such as surgical masks. (With inputs from agencies)

Covid-19 pandemic can be stopped if 70 per cent of public wore masks consistently: Study

Pascal Soriot, CEO of AstraZeneca said that the British-Swedish pharma company is likely to conduct an additional global trials to further assess the efficacy of its COVID-19 vaccine.

AstraZeneca to conduct additional trails to validate better efficacy

Russian Gamaleya research institute, the developers of the Sputnik V Covid-19 vaccine said on Thursday that AstraZeneca should try combining its experimental shot with the Russian one to boost efficacy. 
 
<a href="https://www.wionews.com/world/oxfordastrazeneca-coronavirus-vaccine-to-undergo-new-global-trials-345677">Also read | Oxford/AstraZeneca coronavirus vaccine to undergo new global trials</a> 
 
Adding more colour to the race for a COVID-19 vaccine, the Gamaleya research institute wrote on Twitter that, "Current full dose AstraZeneca regimen resulted in 62% efficacy. If they go for a new clinical trial, we suggest trying a regimen of combining the AZ shot with the #SputnikV human adenoviral vector shot to boost efficacy. Combining vaccines may prove important for revaccinations." 
 
Sputnik V's comment came right after reports that AstraZeneca is likely to run an additional global trial to assess the efficacy of lower dosing regimen of its vaccine.

In August, Russia became the first country to register a COVID-19 vaccine, which was named Sputnik V. The clinical trials of the Sputnik V vaccine, developed by the Gamaleya research institute, have demonstrated that its efficacy rate is over 90 per cent.

AstraZeneca has said it will have as many as 200 million doses of its vaccine by the end of 2020.

The British developed vaccine is viewed as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported at normal fridge temperatures.

With 2,187,990 infections, Russia has the fourth-largest number of Covid-19 cases in the world behind the United States, India and Brazil.

AstraZeneca is likely to run an additional global trial to assess the efficacy of its vaccine, its chief executive Pascal Soriot was quoted as saying by Bloomberg News after questions were raised over the results from its late-stage study.

The British government's Chief Scientific Adviser Patrick Vallance said the main point about the AstraZeneca vaccine was that it worked when asked about these doubts.

"The headline result is the vaccine works and that's very exciting," Vallance said during a news briefing with British Prime Minister Boris Johnson.

(With inputs from agencies) 
&nbsp;

Russian Gamaleya research institute, the developers of the Sputnik V Covid-19 vaccine said on Thursday that AstraZeneca should try combining its experimental shot with the Russian one to boost efficacy.

Russian Gamaleya research institute, the developers of the Sputnik V Covid-19 vaccine said on Thursday that AstraZeneca should try combining its experimental shot with the Russian one to boost efficacy. Also read | Oxford/AstraZeneca coronavirus vaccine to undergo new global trials Adding more colour to the race for a COVID-19 vaccine, the Gamaleya research institute wrote on Twitter that, "Current full dose AstraZeneca regimen resulted in 62% efficacy. If they go for a new clinical trial, we suggest trying a regimen of combining the AZ shot with the #SputnikV human adenoviral vector shot to boost efficacy. Combining vaccines may prove important for revaccinations." Sputnik V's comment came right after reports that AstraZeneca is likely to run an additional global trial to assess the efficacy of lower dosing regimen of its vaccine. In August, Russia became the first country to register a COVID-19 vaccine, which was named Sputnik V. The clinical trials of the Sputnik V vaccine, developed by the Gamaleya research institute, have demonstrated that its efficacy rate is over 90 per cent. AstraZeneca has said it will have as many as 200 million doses of its vaccine by the end of 2020. The British developed vaccine is viewed as offering one of the best hopes for many developing countries because of its cheaper price and ability to be transported at normal fridge temperatures. With 2,187,990 infections, Russia has the fourth-largest number of Covid-19 cases in the world behind the United States, India and Brazil. AstraZeneca is likely to run an additional global trial to assess the efficacy of its vaccine, its chief executive Pascal Soriot was quoted as saying by Bloomberg News after questions were raised over the results from its late-stage study. The British government's Chief Scientific Adviser Patrick Vallance said the main point about the AstraZeneca vaccine was that it worked when asked about these doubts. "The headline result is the vaccine works and that's very exciting," Vallance said during a news briefing with British Prime Minister Boris Johnson. (With inputs from agencies)

Sputnik V can boost efficacy of AstraZeneca vaccine: Russian research centre

Preliminary results on the AstraZeneca vaccine were based on a total of 131 COVID-19 cases in a study involving 11,636 participants.

AstraZeneca defends dosing error in covid-19 vaccine trial

WION Fineprint: How did a smaller dose prove more effective?

Days after the company and the university described the Covid vaccine shots as "highly effective", AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine. 
 
<a href="https://www.wionews.com/world/oxford-astrazeneca-covid-19-vaccine-shows-70-efficacy-can-be-90-effective-trial-data-reveals-344807">Also read: Oxford-AstraZeneca Covid-19 vaccine shows 70% efficacy; can be 90% effective, trial data reveals</a> 
 
On November 23, British-Swedish drug maker AstraZeneca and the University of Oxford had said that the Coronavirus vaccine they are developing is 70.4 per cent effective, on an average, in preventing COVID-19, as per the interim analysis of its late-stage clinical trials conducted in the UK and Brazil.

A statement describing the error made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses.

In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective.

In the group that got two full doses, the vaccine appeared to be 62 per cent effective.

But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness.

Multiple combinations and doses were tried in the volunteers.

They were compared to others who were given a meningitis vaccine or a saline shot.

Meanwhile, China's leading vaccine producer Sinopharm announced on Wednesday that it has submitted an application to the Chinese authorities for marketisation of its COVID-19 vaccine based on data collected from countries carrying out its clinical trials.

A representative of Sinopharm told state-run Global Times that the company had collected data from major countries such as UAE carrying out its vaccine clinical trials.

Results are expected to be good but it is up to the Chinese authorities to make the decision as the government has strict review standards.

Sinopharm previously told the daily that it had reported the phase-III clinical data to China's State Food and Drug Administration and was in the process of giving more detailed data, as requested.

The vaccine maker says it is in the final stage before marketisation, and is now making approval for the marketisation of the vaccine its top priority.

It will be possible to release the phase three data in academic journals after the approval.

"Our data is evaluated by relevant departments following protocols even stricter than in some Western countries, and we are in close communication with the WHO," a representative of Sinopharm told the daily earlier.

A Chinese Foreign Ministry spokesman Zhao Lijian told a media briefing last week that five Chinese vaccine candidates are under clinical trials in countries including the UAE, Brazil, Pakistan and Peru.

Sinopharm, China's state-owned vaccine producer, said on November 19 that its vaccine has been administered to about a million people under the government's emergency use scheme.

"In terms of emergency use, the vaccines were applied to nearly a million people and there has not been a single case of a serious adverse event. People have had only mild symptoms," Liu Jingzhen, chairman of China National Pharmaceutical Group (Sinopharm), said in an interview with a Sichuan-based digital media company that was published on Wednesday.

"Until now, all our progress, from research to clinical trials to production and emergency use, we have been leading the world," he was quoted as saying by the Hong Kong-based South China Morning Post on last Thursday.

His comments came amid criticism that Chinese firms have not publicised the clinical data of its vaccine studies.

(With inputs from agencies)

Days after the company and the university described the Covid vaccine shots as "highly effective", AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

Days after the company and the university described the Covid vaccine shots as "highly effective", AstraZeneca and Oxford University have acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine. Also read: Oxford-AstraZeneca Covid-19 vaccine shows 70% efficacy; can be 90% effective, trial data reveals On November 23, British-Swedish drug maker AstraZeneca and the University of Oxford had said that the Coronavirus vaccine they are developing is 70.4 per cent effective, on an average, in preventing COVID-19, as per the interim analysis of its late-stage clinical trials conducted in the UK and Brazil. A statement describing the error made no mention of why some study participants didn't receive as much vaccine in the first of two shots as expected. In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, AstraZeneca said, the vaccine appeared to be 90 per cent effective. In the group that got two full doses, the vaccine appeared to be 62 per cent effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts. The partial results announced on Monday are from large ongoing studies in the UK and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot. Meanwhile, China's leading vaccine producer Sinopharm announced on Wednesday that it has submitted an application to the Chinese authorities for marketisation of its COVID-19 vaccine based on data collected from countries carrying out its clinical trials. A representative of Sinopharm told state-run Global Times that the company had collected data from major countries such as UAE carrying out its vaccine clinical trials. Results are expected to be good but it is up to the Chinese authorities to make the decision as the government has strict review standards. Sinopharm previously told the daily that it had reported the phase-III clinical data to China's State Food and Drug Administration and was in the process of giving more detailed data, as requested. The vaccine maker says it is in the final stage before marketisation, and is now making approval for the marketisation of the vaccine its top priority. It will be possible to release the phase three data in academic journals after the approval. "Our data is evaluated by relevant departments following protocols even stricter than in some Western countries, and we are in close communication with the WHO," a representative of Sinopharm told the daily earlier. A Chinese Foreign Ministry spokesman Zhao Lijian told a media briefing last week that five Chinese vaccine candidates are under clinical trials in countries including the UAE, Brazil, Pakistan and Peru. Sinopharm, China's state-owned vaccine producer, said on November 19 that its vaccine has been administered to about a million people under the government's emergency use scheme. "In terms of emergency use, the vaccines were applied to nearly a million people and there has not been a single case of a serious adverse event. People have had only mild symptoms," Liu Jingzhen, chairman of China National Pharmaceutical Group (Sinopharm), said in an interview with a Sichuan-based digital media company that was published on Wednesday. "Until now, all our progress, from research to clinical trials to production and emergency use, we have been leading the world," he was quoted as saying by the Hong Kong-based South China Morning Post on last Thursday. His comments came amid criticism that Chinese firms have not publicised the clinical data of its vaccine studies. (With inputs from agencies)

Covid-19 vaccine: AstraZeneca acknowledges manufacturing error, study results affected

The dose of AstraZeneca Plc's Covid antibody that demonstrated the most significant level of adequacy was tried in a more youthful populace than a greater portion that indicated less viability, as per the top of the US&nbsp;Activity Warp Speed program.&nbsp;

The vaccine being&nbsp;developed by&nbsp;Oxford University was 90 per cent&nbsp;viable when a half-portion was given before a full-portion booster, the partners said&nbsp;on Monday.

However, that system was controlled to members in a gathering whose age was covered at 55, Warp Speed's Moncef Slaoui said Tuesday in a call with columnists.&nbsp;

Also read|&nbsp;<a href="https://www.wionews.com/world/covid-19-vaccine-astrazeneca-acknowledges-manufacturing-error-study-results-affected-345425">Covid vaccine: AstraZeneca accepts manufacturing error, study results affected</a>

Analysts have been perplexing about the AstraZeneca report since it was delivered, asking why a more modest portion of the immunisation may have had all the earmarks of being more powerful than a bigger one. The greater part of the individuals in the preliminary got a fake treatment or the routine of two full dosages, which was 62 per cent&nbsp;successful. That gathering included individuals who were more established than 55, Slaoui said.&nbsp;

Also read:<a href="https://www.wionews.com/world/oxford-astrazeneca-covid-19-vaccine-shows-70-efficacy-can-be-90-effective-trial-data-reveals-344807"> Oxford-AstraZeneca Covid-19 vaccine shows 70% efficacy; can be 90% effective, trial data reveals</a>

"I don't really accept that the FDA will take a gander at any preliminary where the portion, or the age accomplices, or some other variable were changed mid-preliminary, unintentionally or purposely," said Geoffrey Porges, a SVB Leerink examiner who anticipated Monday that the US&nbsp;Food and Drug organization would not satisfactory the immunization.&nbsp;

AstraZeneca repeated that the information will be distributed in a companion checked on diary at the appointed time. The drugmaker's American depositary receipts fell as much as 2.2&nbsp;per cent&nbsp;starting at 4 p.m. in New York.&nbsp;

There was no age breakdown given for the two gatherings from AstraZeneca when the organization revealed its outcomes on Monday. The underlying half-portion was utilized in certain individuals due to a blunder in the amount of immunization put into certain vials, Slaoui said.&nbsp;

"There are various factors that we have to comprehend, and what has been the part of every last one of them in accomplishing the distinction inadequacy," Slaoui said.&nbsp;

More seasoned individuals have a more vulnerable reaction than more youthful individuals to certain immunizations, similar to influenza shots. Results from a stage 2 investigation of the Astra-Oxford immunisation distributed a week ago in The Lancet clinical diary affirmed a solid reaction to the antibody in more seasoned individuals.

The dose of AstraZeneca Plc's Covid antibody that demonstrated the most significant level of adequacy was tried in a more youthful populace than a greater portion that indicated less viability, as per the top of the US Activity Warp Speed program.

The dose of AstraZeneca Plc's Covid antibody that demonstrated the most significant level of adequacy was tried in a more youthful populace than a greater portion that indicated less viability, as per the top of the US Activity Warp Speed program. The vaccine being developed by Oxford University was 90 per cent viable when a half-portion was given before a full-portion booster, the partners said on Monday. However, that system was controlled to members in a gathering whose age was covered at 55, Warp Speed's Moncef Slaoui said Tuesday in a call with columnists. Also read| Covid vaccine: AstraZeneca accepts manufacturing error, study results affected Analysts have been perplexing about the AstraZeneca report since it was delivered, asking why a more modest portion of the immunisation may have had all the earmarks of being more powerful than a bigger one. The greater part of the individuals in the preliminary got a fake treatment or the routine of two full dosages, which was 62 per cent successful. That gathering included individuals who were more established than 55, Slaoui said. Also read: Oxford-AstraZeneca Covid-19 vaccine shows 70% efficacy; can be 90% effective, trial data reveals "I don't really accept that the FDA will take a gander at any preliminary where the portion, or the age accomplices, or some other variable were changed mid-preliminary, unintentionally or purposely," said Geoffrey Porges, a SVB Leerink examiner who anticipated Monday that the US Food and Drug organization would not satisfactory the immunization. AstraZeneca repeated that the information will be distributed in a companion checked on diary at the appointed time. The drugmaker's American depositary receipts fell as much as 2.2 per cent starting at 4 p.m. in New York. There was no age breakdown given for the two gatherings from AstraZeneca when the organization revealed its outcomes on Monday. The underlying half-portion was utilized in certain individuals due to a blunder in the amount of immunization put into certain vials, Slaoui said. "There are various factors that we have to comprehend, and what has been the part of every last one of them in accomplishing the distinction inadequacy," Slaoui said. More seasoned individuals have a more vulnerable reaction than more youthful individuals to certain immunizations, similar to influenza shots. Results from a stage 2 investigation of the Astra-Oxford immunisation distributed a week ago in The Lancet clinical diary affirmed a solid reaction to the antibody in more seasoned individuals.

90% efficacy of Oxford's coronavirus vaccine came from younger group

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.

The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

Michele Meixell, a spokesperson for AstraZeneca, said the trials “were conducted to the highest standards.”

In an interview Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures. He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses.

Asked why AstraZeneca shared some information with Wall Street analysts and some other officials and experts but not with the public, he responded, “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.”

AstraZeneca was the third company this month to report encouraging early results on a coronavirus vaccine candidate. At first glance Monday morning, the results looked promising. Depending on the strength at which the doses were given, the vaccine appeared to be either 90% or 62% effective. The average efficacy, the developers said, was 70%.

Almost immediately, though, there were doubts about the data.

The regimen that appeared to be 90% effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses.

The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know.

Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic COVID-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo.

“The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.

Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials.

“I just can’t figure out where all the information is coming from and how it’s combining together,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. She wrote on Twitter that AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.”

With AstraZeneca’s shares declining Monday, company executives held several private conference calls with industry analysts in which they disclosed details that were not in the public announcement, including how the COVID-19 cases broke down across different groups. Such disclosures to analysts are not uncommon in the industry, but they often generate criticism about why the details were not shared with the public.

Bigger problems soon surfaced.

Pangalos told Reuters on Monday that the company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose. Pangalos described the error as “serendipity,” allowing researchers to stumble onto a more promising dosing regimen.

To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked.

The company’s initial announcement didn’t mention the accidental nature of the discovery.

“The reality is, it could end up being quite a useful mistake,” Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.”

He added, “What is there to disclose? It actually doesn’t matter whether it was done on purpose or not.”

In the statement attributed to Oxford, Meixell, the AstraZeneca spokeswoman, said the error stemmed from an issue, which has since been fixed, with how some of the vaccine doses were manufactured.

Then, on Tuesday, Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger.

Pangalos confirmed that Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered.

The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to COVID-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, declined to comment on whether the dosing error would hurt the vaccine’s chances of being authorized. The FDA has said it expects vaccines to be at least 50% effective in preventing or reducing the severity of the disease, a bar that the vaccine appears to have cleared even in the group that got the two full doses.

AstraZeneca’s shares have fallen about 5% this week, while broader stock indexes have climbed to record highs. Investors seem to be disappointed with the murky results, especially compared with the much clearer data released by two of AstraZeneca’s chief rivals in the race for a coronavirus vaccine.

Pfizer and Moderna said this month that their vaccines, which use a technology known as “messenger RNA,” appear to be about 95% effective. Both offerings seem nearly certain to win emergency authorization from the FDA in the coming weeks.

The AstraZeneca vaccine, which uses a different approach involving a chimpanzee virus to provoke an immune response to the coronavirus, had all the hallmarks of a blockbuster.

It was inexpensive — only a few dollars per dose — and easy to mass-produce. Unlike Pfizer and Moderna’s vaccines, AstraZeneca’s could be stored for months in normal refrigerators. The company has estimated it will be able to produce some 3 billion doses next year, enough to vaccinate nearly one-fifth of the global population.

Compared to most of the other leading COVID-19 vaccine developers, AstraZeneca is inexperienced when it comes to vaccines. And even before the chaotic release of results, the company was under scrutiny for its handling of the testing process.

In September, AstraZeneca paused clinical trials worldwide after a participant fell ill — but the company didn’t promptly announce the decision publicly. AstraZeneca also came under fire for providing details about the nature of the illness on a private conference call with investors hosted by the investment bank J.P. Morgan, rather than disseminating the information to the public. Both of those developments were first reported by STAT, which covers health and science news.

Ever since the Oxford-AstraZeneca team emerged as front-runners in the race to develop a vaccine this spring, Prime Minister Boris Johnson of Britain has embraced the effort. The government preordered 100 million doses and cast the research as one of the country’s most important contributions to fighting the pandemic.

Basking in the results on Monday, Johnson said the vaccine “has the makings of a wonderful British scientific achievement.”

In the United States, which has ordered at least 300 million doses of AstraZeneca’s vaccine, the regulatory path forward is unclear. AstraZeneca was circumspect on Monday about its plans for seeking regulatory approval. The company said it would seek guidance from the Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization.

AstraZeneca has not been testing the promising half-strength initial dose in its ongoing U.S. trial. The company said it would work with the agency to add it as quickly as possible to that trial.

Pangalos said the company is planning a global trial to compare the two dosing regimens. The number of participants it will enroll hasn’t yet been determined, but it will be in the thousands.

“The only way they’re going to find out is by specifically and deliberately testing this serendipitous observation,” Moore said. “The onus is on them to prove the speculation.”

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90% effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee. But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing. Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results. Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people. The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic. “I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink. Michele Meixell, a spokesperson for AstraZeneca, said the trials “were conducted to the highest standards.” In an interview Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures. He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses. Asked why AstraZeneca shared some information with Wall Street analysts and some other officials and experts but not with the public, he responded, “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.” AstraZeneca was the third company this month to report encouraging early results on a coronavirus vaccine candidate. At first glance Monday morning, the results looked promising. Depending on the strength at which the doses were given, the vaccine appeared to be either 90% or 62% effective. The average efficacy, the developers said, was 70%. Almost immediately, though, there were doubts about the data. The regimen that appeared to be 90% effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses. The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know. Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic COVID-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo. “The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials. “I just can’t figure out where all the information is coming from and how it’s combining together,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. She wrote on Twitter that AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.” With AstraZeneca’s shares declining Monday, company executives held several private conference calls with industry analysts in which they disclosed details that were not in the public announcement, including how the COVID-19 cases broke down across different groups. Such disclosures to analysts are not uncommon in the industry, but they often generate criticism about why the details were not shared with the public. Bigger problems soon surfaced. Pangalos told Reuters on Monday that the company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose. Pangalos described the error as “serendipity,” allowing researchers to stumble onto a more promising dosing regimen. To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked. The company’s initial announcement didn’t mention the accidental nature of the discovery. “The reality is, it could end up being quite a useful mistake,” Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.” He added, “What is there to disclose? It actually doesn’t matter whether it was done on purpose or not.” In the statement attributed to Oxford, Meixell, the AstraZeneca spokeswoman, said the error stemmed from an issue, which has since been fixed, with how some of the vaccine doses were manufactured. Then, on Tuesday, Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger. Pangalos confirmed that Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered. The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to COVID-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use. Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, declined to comment on whether the dosing error would hurt the vaccine’s chances of being authorized. The FDA has said it expects vaccines to be at least 50% effective in preventing or reducing the severity of the disease, a bar that the vaccine appears to have cleared even in the group that got the two full doses. AstraZeneca’s shares have fallen about 5% this week, while broader stock indexes have climbed to record highs. Investors seem to be disappointed with the murky results, especially compared with the much clearer data released by two of AstraZeneca’s chief rivals in the race for a coronavirus vaccine. Pfizer and Moderna said this month that their vaccines, which use a technology known as “messenger RNA,” appear to be about 95% effective. Both offerings seem nearly certain to win emergency authorization from the FDA in the coming weeks. The AstraZeneca vaccine, which uses a different approach involving a chimpanzee virus to provoke an immune response to the coronavirus, had all the hallmarks of a blockbuster. It was inexpensive — only a few dollars per dose — and easy to mass-produce. Unlike Pfizer and Moderna’s vaccines, AstraZeneca’s could be stored for months in normal refrigerators. The company has estimated it will be able to produce some 3 billion doses next year, enough to vaccinate nearly one-fifth of the global population. Compared to most of the other leading COVID-19 vaccine developers, AstraZeneca is inexperienced when it comes to vaccines. And even before the chaotic release of results, the company was under scrutiny for its handling of the testing process. In September, AstraZeneca paused clinical trials worldwide after a participant fell ill — but the company didn’t promptly announce the decision publicly. AstraZeneca also came under fire for providing details about the nature of the illness on a private conference call with investors hosted by the investment bank J.P. Morgan, rather than disseminating the information to the public. Both of those developments were first reported by STAT, which covers health and science news. Ever since the Oxford-AstraZeneca team emerged as front-runners in the race to develop a vaccine this spring, Prime Minister Boris Johnson of Britain has embraced the effort. The government preordered 100 million doses and cast the research as one of the country’s most important contributions to fighting the pandemic. Basking in the results on Monday, Johnson said the vaccine “has the makings of a wonderful British scientific achievement.” In the United States, which has ordered at least 300 million doses of AstraZeneca’s vaccine, the regulatory path forward is unclear. AstraZeneca was circumspect on Monday about its plans for seeking regulatory approval. The company said it would seek guidance from the Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization. AstraZeneca has not been testing the promising half-strength initial dose in its ongoing U.S. trial. The company said it would work with the agency to add it as quickly as possible to that trial. Pangalos said the company is planning a global trial to compare the two dosing regimens. The number of participants it will enroll hasn’t yet been determined, but it will be in the thousands. “The only way they’re going to find out is by specifically and deliberately testing this serendipitous observation,” Moore said. “The onus is on them to prove the speculation.”

After admitting mistake, AstraZeneca faces difficult questions about its vaccine

AstraZeneca has announced that its vaccine candidate has shown an average efficacy of about 70% , The vaccine candidate has been developed along with the Oxford. The potential vaccine against the novel coronavirus maybe around 90 percent effective, the company said citing interim analysis of results from late-stage clinical trials.

Oxford-AstraZeneca says COVID-19 vaccine candidate is 70% effective

The Oxford Vaccine is being called a milestone in the fight against the Wuhan Virus. Who developed this vaccine? How does it work? How effective is it? How much does it cost? When can you access it?

Gravitas: The Oxford-AstraZeneca Vaccine

The potential vaccine against the novel coronavirus maybe around 90 percent effective, the company said citing interim analysis of results from late-stage clinical trials.

Oxford, AstraZeneca say their candidate prevents average 70% people from getting COVID

Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford.&nbsp;

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It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19.&nbsp;

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Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported.&nbsp;

The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US company.&nbsp;

It also said the AstraZeneca vaccine is in the most advanced stage of human testing in India, adding that the company along with the Indian Council of Medical Research (ICMR) will pursue "early availability" of the doses in India.

India also has at least two indigenously developed vaccine candidates, while Dr Reddy's Labs is conducting a trial for Russia's vaccine candidate.

The development came as coronavirus infections in India, the world's second-worst, reached 8.68 million on Thursday and the death toll rose over 128,000.

 
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Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine.

Serum Insitute of India, the world's largest maker of vaccines, on Thursday said it has already produced 40 million doses of AstraZeneca's potential COVID-19 vaccine. The vaccine is named Covishield by the institute and is jointly developed by pharma giant AstraZeneca and the University of Oxford. Also read | Volunteers face 'severe hangover', headache and pain after getting Pfizer vaccine shot It is originally named ChAdOx1 nCoV-19 and is one of the top contenders in the race to develop vaccines to treat Covid-19. Also read | EU president warns 'recurring cycles' viral spread despite vaccine Serum refused to confirm whether the 40 million doses of vaccine will be supplied globally or only distributed in India, news agency Reuters reported. The vaccine maker also said doses of Novavax vaccine, another top candidate, will be produced soon, adding that the bulk of the drug has been received from the US company. It also said the AstraZeneca vaccine is in the most advanced stage of human testing in India, adding that the company along with the Indian Council of Medical Research (ICMR) will pursue "early availability" of the doses in India. India also has at least two indigenously developed vaccine candidates, while Dr Reddy's Labs is conducting a trial for Russia's vaccine candidate. The development came as coronavirus infections in India, the world's second-worst, reached 8.68 million on Thursday and the death toll rose over 128,000.

India's Serum Institute, world's largest vaccine maker says 40 million doses of AstraZeneca drug produced

Bangladesh has signed a crucial deal with the Serum Institute of India to acquire 30 million doses of a potential vaccine being developed by AstraZeneca for COVID-19.

COVID-19 vaccine: Bangladesh signs deal with Serum Institute of India

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country.

COVID-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden.

AstraZeneca announced that the trial of its vaccine candidate, developed with the Britain's University of Oxford, has resumed in the US, the only country where it remained suspended following a participant's illness six weeks ago.

"The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks," the drugmaker said.

The trial was suspended worldwide on September 6 but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine.

"The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial," AstraZeneca said.

The company added it was hoping to have results later this year, "depending on the rate of infection within the communities where the clinical trials are being conducted."

The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people.

It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials.

In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month.

Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations.

The drugmaker pre-sold hundreds of millions of doses on several continents and signed partnership deals with other producers to ensure the doses could be made locally.

"No evidence" vaccine to blame

Shortly after AstraZeneca's announcement, Johnson &amp; Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill.

"After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified," the group said in a statement.

"The company has found no evidence that the vaccine candidate caused the event."

Just before Friday's announcements, a top US official involved with Operation Warp Speed, the government's vaccine initiative, said he expected the J&amp;J trial to resume quickly.

Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the "most vulnerable" Americans before year's end.

"By the end of January, we believe we'll be able to vaccinate all seniors," Mango said, adding that by March or April, "we believe we'll be able to vaccinate any American who desires a vaccination."

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country.

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday -- providing a glimmer of hope as the number of cases skyrocket across the country. COVID-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden. AstraZeneca announced that the trial of its vaccine candidate, developed with the Britain's University of Oxford, has resumed in the US, the only country where it remained suspended following a participant's illness six weeks ago. "The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks," the drugmaker said. The trial was suspended worldwide on September 6 but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine. "The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial," AstraZeneca said. The company added it was hoping to have results later this year, "depending on the rate of infection within the communities where the clinical trials are being conducted." The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people. It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials. In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month. Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations. The drugmaker pre-sold hundreds of millions of doses on several continents and signed partnership deals with other producers to ensure the doses could be made locally. "No evidence" vaccine to blame Shortly after AstraZeneca's announcement, Johnson & Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill. "After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified," the group said in a statement. "The company has found no evidence that the vaccine candidate caused the event." Just before Friday's announcements, a top US official involved with Operation Warp Speed, the government's vaccine initiative, said he expected the J&J trial to resume quickly. Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the "most vulnerable" Americans before year's end. "By the end of January, we believe we'll be able to vaccinate all seniors," Mango said, adding that by March or April, "we believe we'll be able to vaccinate any American who desires a vaccination."

AstraZeneca, Johnson & Johnson Covid vaccine trials back on track in US 

AstraZeneca Plc has resumed the U.S. trial of its experimental COVID-19 vaccine after approval by regulators, and Johnson & Johnson is preparing to resume its trial on Monday or Tuesday, the companies said on Friday.

Phase-3 trial of Oxford-AstraZeneca Covid-19 vaccine to begin in few days

The US government and AstraZeneca Plc have struck a deal to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment.

This antibody treatment would be a similar class of drug that was used in treating US President Donald Trump. He was treated with Regeneron Pharmaceuticals' antibody drug last week. The president also released a video on Twitter touting its benefits.

The Trump administration has awarded $486 million to the pharmaceutical giant.

The agreement, under Operation Warp Speed, is meant for developing a monoclonal antibody cocktail that can prevent COVID-19, especially in high-risk population like those over 80 years old.

AstraZeneca said it was planning to supply up to 100,000 doses starting toward the end of 2020 and that the US government could acquire up to an additional one million doses in 2021 under a separate agreement.

Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people.

AstraZeneca plans to evaluate the treatment, AZD7442, which is a cocktail of two monoclonal antibodies, in two studies.

One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months in about 5,000 participants, while the second will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

The US government and AstraZeneca Plc have struck a deal to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment. This antibody treatment would be a similar class of drug that was used in treating US President Donald Trump.

The US government and AstraZeneca Plc have struck a deal to develop and secure supplies of up to 100,000 doses of COVID-19 antibody treatment. This antibody treatment would be a similar class of drug that was used in treating US President Donald Trump. He was treated with Regeneron Pharmaceuticals' antibody drug last week. The president also released a video on Twitter touting its benefits. The Trump administration has awarded $486 million to the pharmaceutical giant. The agreement, under Operation Warp Speed, is meant for developing a monoclonal antibody cocktail that can prevent COVID-19, especially in high-risk population like those over 80 years old. AstraZeneca said it was planning to supply up to 100,000 doses starting toward the end of 2020 and that the US government could acquire up to an additional one million doses in 2021 under a separate agreement. Regeneron signed a $450 million deal in July to sell Operation Warp Speed enough doses of its antibody treatment, REGN-COV2, to treat around 300,000 people. AstraZeneca plans to evaluate the treatment, AZD7442, which is a cocktail of two monoclonal antibodies, in two studies. One trial will evaluate the safety and efficacy of the experimental treatment to prevent infection for up to 12 months in about 5,000 participants, while the second will evaluate post-exposure preventative and pre-emptive treatment in roughly 1,100 participants.

US, AstraZeneca strike deal for COVID-19 antibody treatment touted by Trump

Supply deals have so far been agreed for 5.3 billion doses, of which 2.7 billion (51 percent) have been bought by developed countries, territories and regions, including the US, UK, Europe

Rich countries secured deals for 51% of COVID-19 vaccine supply

There are more than 150 vaccine candidates around the world right now and many of them will never make it out of the laboratory but the leading candidates are defying medical norms and&nbsp;promising a safe and efficient vaccine by the end of this year.

Here's a round-up of the leading vaccine candidates and how they are faring in clinical trials.

The leading the COVID-19 vaccine race is AstraZeneca - a British-Swedish multinational but last week&nbsp;the company hit a major roablock. Its trials were halted after a British trial volunteer developed serious side-effects. The company called it a "routine" pause after a sweeping review, the UK trials have resumed but authorities in the US and India are yet to give the go-ahead.

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Pfizer and Biontech are expanding their stage 3 clinical trials that is if the US food and drug administration(FDA) approves. The companies are on track to meet their initial target of 30,000 volunteers by next week.&nbsp;Late-stage trial results are expected by October but it could take months before the vaccine is declared safe.

US-based Moderna therapeutics is all set to begin it's phase 3 trials. The company is in talks with multiple countries to meet its target of 30,000 volunteers,&nbsp;expect a full scale roll-out by the end of 2020.&nbsp;The target is to produce 1 billion doses per year from 2021.

Russia's Sputnik V is the only vaccine in civil circulation. Two hundred and fifty&nbsp;Moscow residents got it last week and 75 per cent of them are yet to display symptoms with small consignments of Sputnik V being shipped across the country but safety concerns remain as a group of eminent scientists recently raised doubts about the accuracy of Russia's clinical trials.

There are more than 150 vaccine candidates around the world right now and many of them will never make it out of the laboratory but the leading candidates are defying medical norms and promising a safe and efficient vaccine by the end of this year.

There are more than 150 vaccine candidates around the world right now and many of them will never make it out of the laboratory but the leading candidates are defying medical norms and promising a safe and efficient vaccine by the end of this year. Here's a round-up of the leading vaccine candidates and how they are faring in clinical trials. The leading the COVID-19 vaccine race is AstraZeneca - a British-Swedish multinational but last week the company hit a major roablock. Its trials were halted after a British trial volunteer developed serious side-effects. The company called it a "routine" pause after a sweeping review, the UK trials have resumed but authorities in the US and India are yet to give the go-ahead. × Pfizer and Biontech are expanding their stage 3 clinical trials that is if the US food and drug administration(FDA) approves. The companies are on track to meet their initial target of 30,000 volunteers by next week. Late-stage trial results are expected by October but it could take months before the vaccine is declared safe. US-based Moderna therapeutics is all set to begin it's phase 3 trials. The company is in talks with multiple countries to meet its target of 30,000 volunteers, expect a full scale roll-out by the end of 2020. The target is to produce 1 billion doses per year from 2021. Russia's Sputnik V is the only vaccine in civil circulation. Two hundred and fifty Moscow residents got it last week and 75 per cent of them are yet to display symptoms with small consignments of Sputnik V being shipped across the country but safety concerns remain as a group of eminent scientists recently raised doubts about the accuracy of Russia's clinical trials.

Amid race for coronavirus cure, companies promise safe and efficient vaccines

This was the first indication that the US trial will remain on hold until the U.S. Food and Drug Administration and a safety panel investigate the case.

What's the status of Oxford-AstraZeneca trials in US; Detailed report

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