COVID-19 vaccines Archives - Page 17 of 24

FDA releases scathing inspection report regarding Emergent BioSolutions plant

An FDA report cites multiple failures in an Emergent BioSolutions plant tapped to produce vaccines for Johnson & Johnson and AstraZeneca.

The vaccine plant had been forced to discard up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine in a single manufacturing batch.

Emergent BioSolutions recently paused production of the vaccine during the FDA inspection and had quarantined doses it had in reserve. The FDA will subject those vaccines to further testing before clearing the way for their distribution, explained two head FDA officials, Peter Marks and Janet Woodcock, in a statement.

It is possible that other batches of vaccine need to be discarded. “There is no assurance that other batches have not been subject to cross-contamination,” the FDA concluded.

“The issuance of findings by the FDA is normal following a facility inspection and provides direction on the necessary steps to improve operations. Emergent is committed to workin…

Why demand for J&J and AstraZeneca COVID-19 vaccines remains unclear

This 2020 image shows a vial of J&J vaccine when it was investigational. Image from Johnson & Johnson.

After the European Medicines Agency determined that the benefits of Johnson & Johnson’s (NYSE:JNJ) COVID-19 vaccine outweigh its risks, the company announced that it would unfreeze its European vaccinate rollout. But assessing demand for the J&J and AstraZeneca vaccines remains difficult. The possible link to rare blood clots could elevate the role of vaccines from Moderna (NSDQ:MRNA), Pfizer (NYSE:PFE) and others.

The European Medicines Agency (EMA) did, however, advise that the vaccine bear a warning describing a risk of rare blood clots.

Although the J&J vaccine had been authorized in the E.U., nations there have not yet used it. After U.S. authorities paused the use of the vaccine, Johnson & Johnson decided to suspend the distribution of the product voluntarily.

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mRNA vaccine led to shingles in a handful of immunocompromised patients

Electron micrograph of the varicella-zoster virus. Image courtesy of CDC.

A group of researchers in Israel has concluded that a mRNA-based vaccine could activate herpes zoster (shingles) in a limited number of people with rheumatic diseases.

The viral infection, which can cause a painful rash, is caused by the varicella-zoster virus, which is also responsible for chickenpox.

In a study focusing on individuals with autoimmune inflammatory rheumatic diseases (AIRD), researchers at the Tel Aviv Sourasky Medical Center and Carmel Medical Center in Haifa followed 491 patients and 99 controls. A total of six patients with AIIRD, or 1.2%, had a reactivation of herpes zoster after vaccination with the BNT162b2 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

No patients in the control arm developed shingles in the study published in Rheumatology.

The researchers acknowledged that the st…

How end-to-end visibility and machine learning can safeguard the vaccine supply chain

Photo by Spencer Davis on Unsplash

For any vaccine, some degree of waste is expected. The problem is inspiring supply-chain companies to explore new technologies that can address a longstanding struggle.

“Before COVID-19, we often saw waste of about 8–10%,” said Ranjeet Banerjee, CEO of Cold Chain Technologies, which provides insulated packaging for drugs and biologics.

A 2019 World Health Organization report citing 2002 data concluded that between 5% and 50% of routine vaccines are wasted.

In some cases, entire pallets or freezers of vaccines are tossed out due to storage unit malfunctions that may have impacted only some vaccine vials.

In general, the biopharma industry loses roughly $35 billion each year as a result of cold-chain, according to a 2019 IQVIA report.

COVID-19 vaccines up the stakes. “COVID vaccine has ten times the complexity,” Banjree said. Not only are a variety of vaccines availabl…

Fauci: J&J vaccination could resume shortly

The third vaccine to win emergency use authorization in the U.S. could reappear after a 10-day pause, according to Dr. Anthony Fauci, the nation’s top disease expert.

FDA and CDC had recommended temporarily suspending the use of the Johnson & Johnson (NYSE:JNJ) vaccine after six women developed serious blood clots within weeks of vaccination.

Fauci stressed that he was uncertain how CDC and FDA might proceed with the vaccine but believed that it was unlikely the pause would become permanent.

The vaccine will likely be accompanied by a warning mentioning a small risk of blood clotting problems, including cerebral venous sinus thrombosis presenting with low platelet count.

“I do think that there will likely be some sort of warning or restriction or risk assessment. I don’t think it’s just going to go back and say, ‘OK, everything’s fine,’ and go right back,” Fauci said in an interview with NBC’s “Meet the Press.”

A CDC advisory panel is s…

EU secures additional 100 million Pfizer-BioNTech vaccine doses

The European Union has decided to exercise an option to purchase additional doses of the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

The two companies will deliver 600 million doses of the vaccine to the EU in 2021.

The Continent’s mass-vaccination efforts have sputtered for much of early 2021, given supply constraints related to the AstraZeneca vaccine and, later, safety concerns related to rare blood clotting problems potentially linked to that vaccine.

In related news, Sweden and several other EU nations are negotiating with Russia to procure that country’s Sputnik V vaccine. The idea behind those talks is to prepare for when the European Medicines Agency authorizes that vaccine.

The EU nations Hungary and Slovakia had already obtained a substantial number of doses of the vaccine, but Russia had asked Slovakia to return hundreds of millions of doses earlier this month, citing contract violations, Reuters repo…

J&J reportedly asked COVID-19 vaccine developers to study blood clot risks

[Image courtesy of Wikipedia]

Johnson & Johnson (NYSE:JNJ) privately contacted other COVID-19 vaccine makers last week to gauge their interest in studying blood clot risks, according to a Wall Street Journal report. Specifically, the company asked whether its rivals — AstraZeneca, Moderna and Pfizer— had new information about blood clots following vaccination and if they were interested in forming an external panel to examine the issue, according to the article citing anonymous sources.

None of the four companies have confirmed nor denied the report.

J&J researchers did state in NEJM that there is insufficient evidence to link six cases of cerebral venous sinus thrombosis (CVST) paired with low platelet counts to the company’s COVID-19 vaccine. Approximately seven million people in the U.S. have received the vaccine.

AstraZeneca (LON:AZN) is said to have been interested in allying wit…

A quick history of the tech behind J&J, AstraZeneca’s COVID-19 vaccines

Transmission electron micrograph of two Adenovirus particles. Image courtesy of Wikipedia.

After regulatory authorities in the U.S. and Europe have either paused or constrained the use of COVID-19 vaccines from AstraZeneca (LON:AZN) and Johnson & Johnson (NYSE:JNJ), some regulatory authorities wonder why the adenoviral-vector vaccines have been potentially linked to similar blood clotting events.

Researchers have observed blood clotting events associated with adenoviral vectors since the late-1990s in early experiments with the platform. But the safety of the platform has improved as genetic engineering has advanced.

The history of using viruses as vectors dates back to the mid-1970s when scientists Dr. J. Michael Bishop and Dr. Harold Varmus demonstrated that gamma-retroviruses could acquire cellular genes.

Researchers began creating adenoviral vectors in the 1980s, testing replication-de…

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

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

Annual COVID-19 vaccines likely, according to Pfizer CEO

The public may require annual vaccines to protect against SARS-CoV-2, Pfizer (NYSE:PFE) CEO Albert Bourla said today.

“It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said in a CNBC interview.

While the details of Pfizer-BioNTech boosters are not yet clear, COVID-19 boosters will likely be based on an mRNA platform.

Adenovirus-vectored vaccines from AstraZeneca and Johnson & Johnson are currently in limited use, given concerns that they could cause rare but serious blood clotting problems.

The mRNA vaccines from Moderna and Pfizer/BioNTech also have a head start, and U.S. officials expect 600 million doses of the vaccines to be delivered by the end of July.

It will be “a stretch for adenoviral-vector vaccines to have any material uptake,” in the U.S., said Navin Jacob, a senior equity research analyst at UBS. “And you can’t really give boosters with the adenoviral-vector vaccin…

Vaccine panel postpones vote on J&J COVID-19 vaccine clot connection

A CDC advisory committee decided not to vote on how Johnson & Johnson’s COVID-19 vaccine should be deployed, reasoning that it needs more time to review data related to rare blood clots potentially linked to the vaccine.

The Advisory Committee on Immunization Practices (ACIP) could ultimately help the CDC decide whether to continue using the vaccine, constrain it or discontinue it altogether.

The cases of cerebral venous sinus thrombosis in J&J COVID-19 recipients deserve serious attention, said Dr. Sarah Long, an ACIP member in the meeting. “Even though it is a very small risk, it is very serious,” explained Long, who is also a professor of pediatrics at the Drexel University College of Medicine. The blood clotting disorder could pose “severe consequences,” Long said.

Several members on the panel stressed they did not want to indefinitely pause the use of the J&J vaccine.

But continuing to roll out the vaccine without more data and…

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

[Photo by Daniel Schludi on Unsplash]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.

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