The US government has cancelled a multimillion-dollar contract with a Maryland-based COVID-19 vaccine manufacturer where 15 million doses of the Johnson &amp; Johnson vaccine were found to be contaminated earlier this year due to unsanitary plant conditions.

According to New York Times, the company, Emergent BioSolutions, disclosed the development on Thursday in a conference call discussing its latest financial results.

Emergent said it will forgo about $180 million due to the contract’s termination.

Emergent BioSolutions played a role in the Trump administration’s effort to speed up vaccine development and distribution. But after winning a contract from the previous administration, Emergent quickly ran into production problems.

Troubles began for Emergent in March 2021, when the ingredients intended for use in producing the Oxford-AstraZeneca vaccine shots contaminated 15 million doses of the Johnson &amp; Johnson single-shot vaccine in its Baltimore plant.

Also read | <a href="https://www.wionews.com/world/germany-demands-replacement-of-60-million-contaminated-jj-vaccine-doses-391456">Germany demands replacement of 60 million contaminated J&amp;J vaccine doses</a>

&nbsp;The lapses at the Bayview factory hampered J&amp;J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries.

The Biden administration then put Johnson &amp; Johnson in direct control of vaccine production there.

Also read |&nbsp;<a href="https://www.wionews.com/world/us-tells-jj-millions-of-vaccine-doses-from-troubled-plant-cant-be-used-390950">US tells J&amp;J millions of vaccine doses from troubled plant can't be used</a>

In June, the Food and Drug Administration issued a 13-page report about the plant, highlighting sanitary and production issues.

The FDA inspectors in their report stated that unsealed bags of medical waste were observed, along with&nbsp;peeling&nbsp;paint and damaged floors and walls&nbsp;that could inhibit proper cleaning.&nbsp;

The report also says that the employees were not properly trained and failed to properly handle ingredients.

The government had already stopped making payments under the contract, which was created in May 2020 and worth over $600 million, the Times reported.

(With inputs from agencies)

The US government has cancelled a multimillion-dollar contract with a Maryland-based COVID-19 vaccine manufacturer where 15 million doses of the Johnson & Johnson vaccine were found to be contaminated earlier this year due to unsanitary plant conditions.

The US government has cancelled a multimillion-dollar contract with a Maryland-based COVID-19 vaccine manufacturer where 15 million doses of the Johnson & Johnson vaccine were found to be contaminated earlier this year due to unsanitary plant conditions. According to New York Times, the company, Emergent BioSolutions, disclosed the development on Thursday in a conference call discussing its latest financial results. Emergent said it will forgo about $180 million due to the contract’s termination. Emergent BioSolutions played a role in the Trump administration’s effort to speed up vaccine development and distribution. But after winning a contract from the previous administration, Emergent quickly ran into production problems. Troubles began for Emergent in March 2021, when the ingredients intended for use in producing the Oxford-AstraZeneca vaccine shots contaminated 15 million doses of the Johnson & Johnson single-shot vaccine in its Baltimore plant. Also read | Germany demands replacement of 60 million contaminated J&J vaccine doses The lapses at the Bayview factory hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries. The Biden administration then put Johnson & Johnson in direct control of vaccine production there. Also read | US tells J&J millions of vaccine doses from troubled plant can't be used In June, the Food and Drug Administration issued a 13-page report about the plant, highlighting sanitary and production issues. The FDA inspectors in their report stated that unsealed bags of medical waste were observed, along with peeling paint and damaged floors and walls that could inhibit proper cleaning. The report also says that the employees were not properly trained and failed to properly handle ingredients. The government had already stopped making payments under the contract, which was created in May 2020 and worth over $600 million, the Times reported. (With inputs from agencies)

US cancels contract with Covid vaccine maker whose plant contaminated 15 million J&J jabs

Zimbabwe on Wednesday approved the <a href="https://www.wionews.com/topics/coronavirus-vaccine">US-made Johnson and Johnson COVID-19 vaccine</a> for emergency use, the first Western-manufactured jab to be administered in the country amid a spiralling third wave of infections.

The only vaccines so far approved in the southern African country — which has frosty relationship with some western nations, including the US — are made in China, Russia and India.

Also read |&nbsp;<a href="https://www.wionews.com/world/coronavirus-deaths-surge-by-21-cases-can-exceed-200-million-in-two-weeks-who-401228" hreflang="en">Coronavirus deaths surge by 21% , cases can exceed 200 million in two weeks: WHO</a>

But the government came under fire for turning down an African Union (AU) donation of three million J&amp;J doses in June — citing storage issues and possible side-effects — despite surging cases and vaccine shortages.

And now, "based on the review of the submitted quality, safety and efficacy data... emergency use authorisation has been granted for (the vaccine) manufactured by Johnson and Johnson," the Medicines Control Authority of Zimbabwe said in a letter to government seen by journalists on Wednesday.

Also read |&nbsp;<a href="https://www.wionews.com/world/astrazeneca-and-pfizer-mixed-shots-boost-antibody-levels-study-400778" hreflang="en">AstraZeneca and Pfizer mixed shots boost antibody levels: Study</a>

Critics had accused the government of refusing the AU donation for political reasons, noting that J&amp;J doses required the same storage temperature as China's Sinopharm and Sinovac shots. &nbsp; &nbsp;&nbsp;

Both the US and the European Union have, over the past decade, imposed economic sanctions on Zimbabwean entities and various top officials for alleged rights abuses.

President Emmerson Mnangagwa last year unsuccessfully asked the United Nations for support in fighting the sanctions, claiming they hurt the country's economic development.

Just over 694,600 people in Zimbabwe have been fully vaccinated, while 1.5 million have received a first shot out of a population of 14.8 million.

A warning this month that people would soon face restrictions if they are not fully immunised sparked a rush to vaccination sites.

To date, Zimbabwe has recorded more than 70,400 cases of Covid-19, of which at least 3,280 have been fatal.

Zimbabwe on Wednesday approved the US-made Johnson and Johnson COVID-19 vaccine for emergency use, the first Western-manufactured jab to be administered in the country amid a spiralling third wave of infections.

Zimbabwe on Wednesday approved the US-made Johnson and Johnson COVID-19 vaccine for emergency use, the first Western-manufactured jab to be administered in the country amid a spiralling third wave of infections. The only vaccines so far approved in the southern African country — which has frosty relationship with some western nations, including the US — are made in China, Russia and India. Also read | Coronavirus deaths surge by 21% , cases can exceed 200 million in two weeks: WHO But the government came under fire for turning down an African Union (AU) donation of three million J&J doses in June — citing storage issues and possible side-effects — despite surging cases and vaccine shortages. And now, "based on the review of the submitted quality, safety and efficacy data... emergency use authorisation has been granted for (the vaccine) manufactured by Johnson and Johnson," the Medicines Control Authority of Zimbabwe said in a letter to government seen by journalists on Wednesday. Also read | AstraZeneca and Pfizer mixed shots boost antibody levels: Study Critics had accused the government of refusing the AU donation for political reasons, noting that J&J doses required the same storage temperature as China's Sinopharm and Sinovac shots. Both the US and the European Union have, over the past decade, imposed economic sanctions on Zimbabwean entities and various top officials for alleged rights abuses. President Emmerson Mnangagwa last year unsuccessfully asked the United Nations for support in fighting the sanctions, claiming they hurt the country's economic development. Just over 694,600 people in Zimbabwe have been fully vaccinated, while 1.5 million have received a first shot out of a population of 14.8 million. A warning this month that people would soon face restrictions if they are not fully immunised sparked a rush to vaccination sites. To date, Zimbabwe has recorded more than 70,400 cases of Covid-19, of which at least 3,280 have been fatal.

Zimbabwe approves J&J vaccine as third virus wave rages

The US&nbsp;Centers for Disease Control and Prevention said on Wednesday it had found more cases of potentially life-threatening blood clotting among people who received the Johnson &amp; Johnson COVID-19 vaccine and sees a "plausible causal association".

The CDC said in a presentation the agency has now identified 28 cases of thrombosis with thrombocytopenia syndrome (TTS) among the more than 8.7 million people who had received the J&amp;J vaccine. TTS involves blood clots accompanied by a low level of platelets - the cells in the blood that help it to clot.

Also read |&nbsp;<a data-ctorig="https://www.wionews.com/world/us-turning-a-corner-on-pandemic-says-white-house-coordinator-384020" data-cturl="https://www.google.com/url?client=internal-element-cse&amp;cx=006054055338965708568:09spwrlibei&amp;q=https://www.wionews.com/world/us-turning-a-corner-on-pandemic-says-white-house-coordinator-384020&amp;sa=U&amp;ved=2ahUKEwjzqsH-hsbwAhUb73MBHd0VAUQQFjACegQIAxAC&amp;usg=AOvVaw3uUoEIvRjC4YmtKZHS4-gu" dir="ltr" href="https://www.wionews.com/world/us-turning-a-corner-on-pandemic-says-white-house-coordinator-384020" target="_blank">US turning a corner on pandemic, says White House coordinator</a>

So far, three of the 28 have died. Previously, as of April 25, the CDC had reported 17 cases of clotting among nearly 8 million people given vaccines.

The Advisory Committee on Immunization Practices or ACIP, which advises the U.S. CDC, recommended on April 23 that the U.S. lift a 10-day pause on the J&amp;J vaccinations imposed to review safety data on the clotting issue. The panel will review the new data later on Wednesday.

The CDC said on Wednesday the events appear similar to what is being observed following administration of the AstraZeneca COVID-19 vaccine in Europe.

Also read |&nbsp;<a href="https://www.wionews.com/world/ray-of-hope-cdc-predicts-us-covid-cases-could-see-sharp-decline-in-july-383167">Ray of hope: CDC predicts US covid cases could see sharp decline in July</a>

Both vaccines are based on technology that uses adenoviruses, which can cause the common cold, as vectors. The modified viruses are used to carry DNA instructions into the body to make specific coronavirus proteins, priming the immune system to make antibodies that fight off the actual coronavirus.

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors.

The syndrome does not appear to be associated with either of the COVID-19 vaccines produce by Pfizer Inc and BioNTech SA or Moderna Inc.

Most of the cases were among women aged 18 to 49, the CDC said, with rates among women aged 30-39 at 12.4 cases per million and those aged 40-49 at 9.4 cases per million.

Only six of the clotting events identified were in men.

Symptoms typically occur several days after vaccination to up to 2 weeks.

The US Centers for Disease Control and Prevention said on Wednesday it had found more cases of potentially life-threatening blood clotting among people who received the Johnson & Johnson COVID-19 vaccine and sees a "plausible causal association".

The US Centers for Disease Control and Prevention said on Wednesday it had found more cases of potentially life-threatening blood clotting among people who received the Johnson & Johnson COVID-19 vaccine and sees a "plausible causal association". The CDC said in a presentation the agency has now identified 28 cases of thrombosis with thrombocytopenia syndrome (TTS) among the more than 8.7 million people who had received the J&J vaccine. TTS involves blood clots accompanied by a low level of platelets - the cells in the blood that help it to clot. Also read | US turning a corner on pandemic, says White House coordinator So far, three of the 28 have died. Previously, as of April 25, the CDC had reported 17 cases of clotting among nearly 8 million people given vaccines. The Advisory Committee on Immunization Practices or ACIP, which advises the U.S. CDC, recommended on April 23 that the U.S. lift a 10-day pause on the J&J vaccinations imposed to review safety data on the clotting issue. The panel will review the new data later on Wednesday. The CDC said on Wednesday the events appear similar to what is being observed following administration of the AstraZeneca COVID-19 vaccine in Europe. Also read | Ray of hope: CDC predicts US covid cases could see sharp decline in July Both vaccines are based on technology that uses adenoviruses, which can cause the common cold, as vectors. The modified viruses are used to carry DNA instructions into the body to make specific coronavirus proteins, priming the immune system to make antibodies that fight off the actual coronavirus. Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors. The syndrome does not appear to be associated with either of the COVID-19 vaccines produce by Pfizer Inc and BioNTech SA or Moderna Inc. Most of the cases were among women aged 18 to 49, the CDC said, with rates among women aged 30-39 at 12.4 cases per million and those aged 40-49 at 9.4 cases per million. Only six of the clotting events identified were in men. Symptoms typically occur several days after vaccination to up to 2 weeks.

US CDC finds more clotting cases after J&J vaccine, sees causal link

France is sticking to its plan to give over-55s the Johnson &amp; Johnson <a href="https://www.wionews.com/topics/coronavirus-vaccine">vaccine</a> suspended in the US and South Africa over rare blood clots, a government spokesman said Wednesday.

Gabriel Attal also reaffirmed the government's confidence in the AstraZeneca jab as an "essential tool" in the fight against Covid-19, hours after Denmark said it was stopping its use, also over rare incidents of clots in people who received the vaccine.

Also read |&nbsp;<a href="https://www.wionews.com/science/moderna-says-protection-from-its-covid-19-vaccine-still-strong-six-months-on-377482" hreflang="en">Moderna says protection from its COVID-19 vaccine still strong six months on</a>

France has already been using the AstraZeneca jab among over-55s and had been planning to boost its campaign with the Johnson &amp; Johnson vaccine, which is similar to the AstraZeneca shot.

That plan appeared to be in jeopardy after Johnson &amp; Johnson said Tuesday it would delay rollout of the vaccine in Europe after it was suspended in the US.

Also read |&nbsp;<a href="https://www.wionews.com/world/blood-clots-are-latest-curse-of-coronavirus-vaccines-all-you-need-to-know-377437" hreflang="en">Blood clots are latest curse of coronavirus vaccines. All you need to know</a>

But Attal said the government had received a first delivery of 200,000 doses, which "arrived on our territory at the start of the week and are being delivered to GPs and pharmacies".

His remarks came as EU chief Ursula von der Leyen warned the bloc was turning more heavily to BioNTech/Pfizer to make up for suspended Johnson &amp; Johnson vaccine doses and for the longer term.

Her remarks came as more and more EU countries limit the use of the adenovirus-type vaccines produced by AstraZeneca and Johnson &amp; Johnson to older people, who have yet to be affected by the clotting issue.

Denmark on Wednesday became the first EU country to abandon the AstraZeneca vaccine altogether, despite the World Health Organization and European Medicines Agency deeming it safe.

Reacting to the Danish move, Attal said: "We have confidence in the AstraZeneca vaccine as an essential tool in the fight against the Covid-19 epidemic.&nbsp;

"It is important that this vaccine continue to be deployed. It is a vaccine that is safe and works."

France is sticking to its plan to give over-55s the Johnson & Johnson vaccine suspended in the US and South Africa over rare blood clots, a government spokesman said Wednesday.

France is sticking to its plan to give over-55s the Johnson & Johnson vaccine suspended in the US and South Africa over rare blood clots, a government spokesman said Wednesday. Gabriel Attal also reaffirmed the government's confidence in the AstraZeneca jab as an "essential tool" in the fight against Covid-19, hours after Denmark said it was stopping its use, also over rare incidents of clots in people who received the vaccine. Also read | Moderna says protection from its COVID-19 vaccine still strong six months on France has already been using the AstraZeneca jab among over-55s and had been planning to boost its campaign with the Johnson & Johnson vaccine, which is similar to the AstraZeneca shot. That plan appeared to be in jeopardy after Johnson & Johnson said Tuesday it would delay rollout of the vaccine in Europe after it was suspended in the US. Also read | Blood clots are latest curse of coronavirus vaccines. All you need to know But Attal said the government had received a first delivery of 200,000 doses, which "arrived on our territory at the start of the week and are being delivered to GPs and pharmacies". His remarks came as EU chief Ursula von der Leyen warned the bloc was turning more heavily to BioNTech/Pfizer to make up for suspended Johnson & Johnson vaccine doses and for the longer term. Her remarks came as more and more EU countries limit the use of the adenovirus-type vaccines produced by AstraZeneca and Johnson & Johnson to older people, who have yet to be affected by the clotting issue. Denmark on Wednesday became the first EU country to abandon the AstraZeneca vaccine altogether, despite the World Health Organization and European Medicines Agency deeming it safe. Reacting to the Danish move, Attal said: "We have confidence in the AstraZeneca vaccine as an essential tool in the fight against the Covid-19 epidemic. "It is important that this vaccine continue to be deployed. It is a vaccine that is safe and works."

France sticks to plan to give J&J vaccine to over 55s

The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca's COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

US pauses use of J&J vaccine over rare blood clots

Johnson &amp; Johnson is in talks with&nbsp;India's government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.

The US&nbsp;drugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa.

The news comes as some parts of&nbsp;India&nbsp;face a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of COVID-19 infections.&nbsp;India's government, however, has said there is no shortage of shots.

J&amp;J had sent a letter to&nbsp;India's Central Drugs Standard Control Organisation (CDSCO) saying it would "very shortly apply for permission to conduct clinical bridging trials in&nbsp;India".&nbsp;

"We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in&nbsp;India, subject to local regulatory approvals," a local J&amp;J representative said via email.

A bridging study tests the safety and immunogenicity of a vaccine, and&nbsp;India&nbsp;has indicated that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme.

Separately, J&amp;J has a deal with&nbsp;Indian firm Biological E Ltd to contract-manufacture its vaccine.

India&nbsp;currently has two approved vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech.

There are other vaccine candidates in trials in&nbsp;India&nbsp;including Russia's Sputnik-V and a shot developed by Cadila Healthcare Ltd.

COVID-19 infections in&nbsp;India&nbsp;rose by a record number for a third straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months.

Johnson & Johnson is in talks with India's government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday. The US drugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa.

Johnson & Johnson is in talks with India's government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday. The US drugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa. The news comes as some parts of India face a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of COVID-19 infections. India's government, however, has said there is no shortage of shots. J&J had sent a letter to India's Central Drugs Standard Control Organisation (CDSCO) saying it would "very shortly apply for permission to conduct clinical bridging trials in India". "We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate in India, subject to local regulatory approvals," a local J&J representative said via email. A bridging study tests the safety and immunogenicity of a vaccine, and India has indicated that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme. Separately, J&J has a deal with Indian firm Biological E Ltd to contract-manufacture its vaccine. India currently has two approved vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech. There are other vaccine candidates in trials in India including Russia's Sputnik-V and a shot developed by Cadila Healthcare Ltd. COVID-19 infections in India rose by a record number for a third straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months.

J&J says in talks with Indian government for trial of single-dose vaccine

Johnson &amp; Johnson on Thursday applied for emergency use authorisation of its single-dose <a href="https://www.wionews.com/topics/coronavirus-vaccine">coronavirus vaccine</a>&nbsp;to US health regulators.&nbsp;

If approved, the vaccine will be third for the worst-hit United States, the country which has seen over 450,000 deaths due to the deadly virus.

Watch |&nbsp;

<div class="videoWrapper trancodeVideo"><iframe allowfullscreen="" autoplay="1" class="includeVideo" frameborder="0" height="350" src="https://www.wionews.com/videos/your-story-oxford-to-study-alternate-doses-of-covid-19-vaccine-by-different-manufacturers-361398/embed" style="width:100%;max-width:560px;" width="560"></iframe></div>

&nbsp;

J&amp;J's Covid-19 vaccine has some logistical advantages over other rivals as the drug does not require deep-freeze storage and only a single-shot is required for inoculation.&nbsp;

Also read | <a href="https://www.wionews.com/world/johnson-and-johnson-says-covid-vaccine-66-effective-overall-less-so-against-s-african-variant-360129">Johnson and Johnson says Covid vaccine 66% effective overall, less so against S African variant</a>

However, a January 29 report said that the vaccine has an efficacy rate of 66 per cent, which is significantly lower than Moderna and Pfizer's Covid-19 drug.&nbsp;

Various trials have also suggested that J&amp;J's vaccine does not protect against highly transmissible coronavirus variant found in South Africa.&nbsp;

The U.S. Food and Drug Administration (FDA) said on Thursday that its vaccines committee will meet on February 26 to discuss J&amp;J's vaccine.&nbsp;

J&amp;J is ready to begin shipping to roll out the drug in March once emergency approval is granted, Paul Stoffels, chief scientific officer of the pharma giant, said.&nbsp;

The US has agreed to pay J&amp;J $1 billion for 100 million doses and the company plans to deliver a billion doses in 2021.&nbsp;

In the trial of about 44,000 volunteers in eight nations, the efficacy of J&amp;J's vaccine was 72 per cent in the US, 66 per cent in Latin America and 57 per cent in South Africa.&nbsp;

Pfizer and Moderna's vaccines have an effectiveness of about 95 per cent, though the trial results of both the drugmakers were largely based in the US.&nbsp;

 
&nbsp;

Johnson & Johnson on Thursday applied for emergency use authorisation of its single-dose coronavirus vaccine to US health regulators. If approved, the vaccine will be third for the worst-hit United States, the country which has seen over 450,000 deaths due to the deadly virus.

Johnson & Johnson on Thursday applied for emergency use authorisation of its single-dose coronavirus vaccine to US health regulators. If approved, the vaccine will be third for the worst-hit United States, the country which has seen over 450,000 deaths due to the deadly virus. Watch | J&J's Covid-19 vaccine has some logistical advantages over other rivals as the drug does not require deep-freeze storage and only a single-shot is required for inoculation. Also read | Johnson and Johnson says Covid vaccine 66% effective overall, less so against S African variant However, a January 29 report said that the vaccine has an efficacy rate of 66 per cent, which is significantly lower than Moderna and Pfizer's Covid-19 drug. Various trials have also suggested that J&J's vaccine does not protect against highly transmissible coronavirus variant found in South Africa. The U.S. Food and Drug Administration (FDA) said on Thursday that its vaccines committee will meet on February 26 to discuss J&J's vaccine. J&J is ready to begin shipping to roll out the drug in March once emergency approval is granted, Paul Stoffels, chief scientific officer of the pharma giant, said. The US has agreed to pay J&J $1 billion for 100 million doses and the company plans to deliver a billion doses in 2021. In the trial of about 44,000 volunteers in eight nations, the efficacy of J&J's vaccine was 72 per cent in the US, 66 per cent in Latin America and 57 per cent in South Africa. Pfizer and Moderna's vaccines have an effectiveness of about 95 per cent, though the trial results of both the drugmakers were largely based in the US.

Johnson & Johnson seeks emergency use authorisation for its Covid-19 vaccine

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