COVID-19 vaccines Archives - Page 18 of 24

EU won’t renew J&J, AstraZeneca vaccine contracts, report says

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Reports from Italy claim that the European Union Commission won’t renew COVID-19 vaccine contracts next year with AstraZeneca and Johnson & Johnson.

According to Reuters, Italian outlet La Stampa reported that sources from the Italian health ministry have said the commission does not want to pursue contract renewals with those two companies once those encompassing the current year expire, with Brussels reportedly emphasizing its focus on mRNA vaccines like those produced by Pfizer/BioNTech and Moderna.

The report quoted an EU Commission spokesperson as saying the commission is keeping all options open to prepare for the next stages of the pandemic, but it can’t comment on contractual matters.

Later on today, the EU Commission president stated that the EU was in talks with Pfizer and BioNTech over a new contract for 1.8 billion doses as well, …

Pfizer to boost vaccine production for U.S. by 10%

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Pfizer will deliver 10% more of its COVID-19 vaccine to the U.S. by the end of May than originally planned, its CEO tweeted yesterday.

The tweet follows the federal government’s decision to recommend a temporary halt in the distribution of Johnson & Johnson’s single-dose vaccine, which has been tied to rare instances of blood clot formation in women.

Pfizer will deliver 220 million doses of its two-dose vaccine by the end of May and supply the full 300 million it agreed to for the end of July two weeks early, CEO Albert Bourla tweeted. “In the fight against COVID-19, we’re in this together,” he added.

As of Monday, more than 6.8 million doses of the J&J single-dose vaccine had been administered in the U.S. Among recipients of those doses, six cases of a rare and severe type of blood clot have been reported. The CDC and FDA are reviewi…

Researcher: Neuroinflammation may be behind tinnitus reports in some COVID-19 vaccine recipients

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Peripheral cytokines from COVID-19 vaccines could cause or exacerbate tinnitus, or ringing in the ears, theorized Shaowen Bao, an associate professor of neuroscience and physiology at the University of Arizona.

Recent articles on Drug Discovery & Development on the possible link between tinnitus and COVID-19 vaccines have attracted hundreds of comments.

Some 0.65% of COVID-19 vaccine recipients who filed reports in CDC’s Vaccine Adverse Event Reporting System (VAERS) reported the issue. Although VAERS is not exhaustive, those 369 reports out of a total of 56,722 VAERS entries represent a tiny fraction of 190 million COVID-19 vaccine doses that have been administered in the U.S. to date.

Six volunteers in J&J’s Phase 3 trial for its COVID-19 vaccine complained of tinnitus. FDA, however, concluded there was insufficient evidence to link the issue t…

6 assumptions about COVID-19 vaccines as AstraZeneca and J&J face safety scrutiny

[Photo by Daniel Schludi on Unsplash]

With COVID-19 cases surging in many parts of the world, the need is high for multiple vaccines to slow the virus.

But the fate of adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson has become murky after a limited number of people receiving those vaccines have developed blood clot disorders.

Officials in both the EU and the U.S. suspect there could be a link between adenovirus-based COVID-1 vaccines and blood clotting problems such as cerebral venous sinus thrombosis. Authorities in both countries have either temporarily halted or constrained the use of adenovirus vaccines.

Russia’s Sputnik V and China’s CanSino Biologics also have COVID-19 vaccines based on an adenovirus platform.

1. The blood clotting problems seems rare but more common in women

Even though blood clotting problems have gotten a substantial amount of att…

EMA begins investigation of J&J COVID-19 vaccine’s blood clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died.

Get the full story from our sister site, Drug Discovery & Development.

EMA begins investigation of J&J COVID-19 vaccine’s blot clotting potential

The European Medicines Agency (EMA) announced that it is beginning a review of blood clots appearing in a handful of recipients of the Johnson & Johnson COVID-19 vaccine.

EMA recently concluded that blood clots associated with low blood platelet levels were a “very rare” side effect of Vaxzevria, the vaccine from AstraZeneca.

Four recipients of the Johnson & Johnson vaccine have had such blood clotting events. One of those individuals has died.

A Johnson & Johnson summary of the Ad26.COV2.S vaccine clinical trial cited a “numerical imbalance” for deep vein thrombosis (DVT) and pulmonary embolism (PE) between vaccine and placebo recipients. In the vaccine arm, there were five cases of DVT and four cases of PE. By contrast, there were two DVT reports and one of PE in the study’s placebo arm.

The company has stressed that it has found no causal relationship between the rare blood clotting events and its vaccine.

European regul…

Johnson & Johnson COVID-19 vaccine shipments plunge

Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000.

The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes an Emergent BioSolutions plant in Baltimore to produce the vaccine.

Get the full story from our sister site, Pharmaceutical Processing World.

Johnson & Johnson COVID-19 vaccine shipments plunge

Johnson & Johnson will cut COVID-19 vaccine shipments by 86% in the coming week, according to CDC projections. The week of April 5, the company shipped nearly 5 million doses. Next week, that figure could fall to approximately 700,000.

The company anticipates that it can eventually deliver up to 8 million doses weekly, assuming FDA authorizes an Emergent BioSolutions plant in Baltimore to produce the vaccine.

Johnson & Johnson (NYSE:JNJ) announced that it would assume complete control over the production of its COVID-19 vaccine at the facility of Emergent BioSolutions Bayview, which is a contract manufacturing partner of J&J.

A factory error at the Emergent BioSolutions plant ruined up to 15 million COVID-19 vaccine doses. An additional 62 million doses of the vaccine could be discarded if the company determines they are at risk of contamination.

FDA has not indicated when it might authorize production lines at the Emergent BioSolu…

Icosavax wins $100M in funding for clinical trials for bivalent RSV/hMPV vaccine candidate

Virus-like particle (VLP) technology specialist Icosavax has closed $100 million in Series B financing, which it will use for clinical studies and continued development of a SARS-CoV-2 vaccine candidate.

One focus of the clinical research will be clinical trials for its bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine.

RSV is a common respiratory virus that generally causes mild illness but can cause serious complications in infants and the elderly. In a similar vein, hMPV generally causes symptoms consistent with other upper respiratory tract illnesses, but severe infections can require hospitalization. Both viruses are common causes of viral pneumonia. No vaccines are available for either virus.

“VLP vaccines have the potential to be extremely effective,” said Adam Simpson, CEO of Icosavax. “For example, naturally occurring VLPs have delivered effective licensed vaccines, including against human papi…

AstraZeneca vaccine drama complicating the pandemic fight

The recent spectacle surrounding Vaxzevria, the AstraZeneca (LON:AZN) COVID-19 vaccine, could exacerbate vaccine hesitancy, which is significant in many parts of the world.

In the U.S., the independent data and safety monitoring board overseeing the Phase 3 trial contacted government authorities with concerns that the summary data were misleading.

More recently, the European Medicines Agency (EMA) has concluded that blood clots are a “very rare” side effect of the vaccine, and the U.K. and other countries have constrained its use. There could be a backlash against the vaccine.

People “who are anti-vaxxers are now going to go and say: ‘I told you so, we were right,’ said Iain Duncan Smith, former Leader of the Conservative Party in the U.K. “This is going to be very difficult and damaging. It plays into the hands of those who are trying their level best to disrupt the vaccination program.”

Given that dynamic, AstraZeneca should stress i…

NIH launches study of allergic reactions to COVID-19 vaccines

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The NIH today announced that a clinical trial is underway to study whether people who are highly allergic or have a mast cell disorder are more likely to develop an allergic reaction to the Moderna or Pfizer-BioNTech COVID-19 vaccines.

Reports of severe allergic reactions to COVID-19 vaccines have made headlines since the rollout to the public began. Still, such anaphylactic reactions are rare, with only a few cases per million doses. To put things in perspective, tens of thousands of Americans end up in emergency rooms annually with severe allergic reactions.

Most of the rare, severe allergic reactions to the vaccines took place among people with a history of allergies — many of them with prior experience of having a life-threatening allergic reaction called anaphylaxis. Researchers are still uncertain why there are rare cases of anaphylactic reactions after the Mode…

AstraZeneca vaccine linked to rare blood clots, according to EMA official

European Medicines Agency (EMA) official Marco Cavaleri said there was a link between AstraZeneca’s COVID-19 vaccine and rare reports of blood clots, including pulmonary embolism, deep vein thrombosis and thrombocytopenia, according to a Reuters report.

Two separate research groups in Europe had reached similar conclusions regarding the blood clots in March.

AstraZeneca had previously downplayed the possibility that its COVID-19 vaccine is linked to such events. The company did not immediately respond to a request for a comment.

The benefits of the vaccine, which was jointly developed by AstraZeneca and Oxford University, still outweigh the risks, said Marco Cavaleri, head of health threats and vaccine strategy, in an interview with Rome’s Il Messaggero paper.

EMA is poised to make a formal announcement regarding the subject, Cavaleri said.

The EMA press office itself notes that it “has not yet reached a conclusion, and the review is curren…