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Israel investigating heart inflammation cases in Pfizer COVID-19 vaccine recipients

Histopathology of myocarditis. [ Image courtesy of Wikipedia]

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX).

More than five million people in the country have received the vaccine.

The agency, however, has not yet established a causal relationship between the events and the vaccine.

Pfizer has also reported that it has not observed a higher rate of myocarditis among vaccine recipients than in the general population.

The Israeli data suggest that myocarditis reports may be more common after the second vaccine dose.

Most of the people with myocarditis were 30 years old or younger.

Establishing causation for myocarditis can be challenging. Researchers have linked the condition to an array of pathogens, including viruses, bacteria and …

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 an 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).

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

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…

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…

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.

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.

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%

Image courtesy of Wikipedia

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.

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

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

Image courtesy of Wikipedia

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…

Pfizer asks FDA to authorize its COVID-19 vaccine for younger teens

Pfizer (NYSE:PFE) and its German partner BioNTech (NSDQ:BNTX) have asked FDA to extend the authorization of their COVID-19 vaccine to the ages of 12 to 15.

FDA authorized the vaccine for people 16 and older on Dec. 11, 2020.

The agency will likely extend its prior authorization to younger adolescents “if the data submitted support it,” according to Dr. Arnold Monto, acting chair of the Vaccines and Related Biological Products Advisory Committee meetings related to the Pfizer-BioNTech.

Pfizer plans to seek permission from other regulatory agencies to administer the vaccine to children 12 and over in the coming weeks.

The company currently has a Phase 3 trial underway involving 2,260 adolescents 12 to 15. The vaccine was 100% effective in that study, besting the results of a separate trial involving volunteers aged 16 to 25.

All 50 states plan to open up vaccine eligibility to those over 16 starting April 19.

Pfizer and BioNTech a…

Pfizer introduces oral SARS-CoV-2 inhibitor

An experimental oral antiviral from Pfizer that recently became the focus of a Phase 1 study was featured at the American Chemical Society Spring 2021 meeting.

Known as PF-07321332, the compound is a protease inhibitor. It works by binding to a viral enzyme known as protease to block viral replication.

Protease inhibitors are used to treat HIV/AIDS and hepatitis C, but PF-07321332 is the first oral protease inhibitor to target the SARS-CoV-2 virus.

Protease inhibitors are generally well tolerated. Side effects of protease inhibitors, in general, can include diarrhea, nausea and vomiting and insulin resistance.

Pfizer has also developed PF-07304814, a similar protease inhibitor, but that compound is intended for intravenous use.

Eli Lilly and Regeneron have developed infusion-based SARS-CoV-2 antibody drugs, but they have not been broadly used.

PF-07321332, if authorized, could be prescribed when the first symptoms of COVID-19 emerge.…