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Prominent COVID-19 vaccine makers continue to make case for boosters

Image from Sam Moqadam on Unsplash

The case for boosters has gained ground amidst the surge in COVID-19 infections over the past month.

BioNTech CEO Özlem Türeci recently recommended that health officials administer a third dose six to 12 months after the second dose to “maintain the highest level of protection.”

Pfizer CEO Dr. Albert Bourla has made similar recommendations.

Pfizer and BioNTech are working together on developing variant-specific vaccines, including one for Delta, but Türeci recently said that their current vaccine would be an effective booster.

In its most recent earnings presentation, Pfizer released early data concluding that a third dose of its COVID-19 vaccine led to a substantial increase in SARS-CoV-2 neutralization titers. For the wild-type virus, titers increased more than five to eightfold. For the Delta variant, neutralization titers increased more than fivef…

Study finds mild short-term impact from myocarditis after COVID-19 vaccination

Doses of the COVID-19 vaccine at Walter Reed National Military Medical Center, Bethesda, Md. DoD photo by Lisa Ferdinando.

Despite the rare risk of myocarditis in children, the benefits of the Pfizer-BioNTech BNT162b2 vaccine likely outweigh the risks, according to a recent JAMA Cardiology report.

A separate pre-print study found that adolescents’ risk of contracting myocarditis is substantially higher after contracting COVID-19 than from receiving mRNA vaccines targeting the novel coronavirus. An earlier JAMA Cardiology article reached similar conclusions, reporting that “as many 1% of highly fit athletes with mild COVID-19 infection have evidence of myocarditis on [cardiac] MRI.”

A separate study in Circulation estimated that between 12–20% of hospitalized COVID-19 patients develop myocarditis.

The recent JAMA report did, however, suggest that the second dose of the BNT162b2 vac…

Novavax stock surges after striking EU COVID-19 vaccine deal

Novavax (NSDQ:NVAX) saw its stock jump more than 20% in afternoon trading after the European Commission agreed to purchase up to 200 million doses of its vaccine.

The Gaithersburg, Md.–based vaccine maker announced in March that its NVX-CoV2373 vaccine was 96.4% effective against the original SARS-CoV-2 strain in a U.K. trial. The efficacy in a later trial conducted in the U.S. and Mexico was 90.4%, according to a June NIH press release.

But the company had been slow to get its vaccine onto the market. In the U.S., the company plans on filing for emergency use authorization in late September.

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

COVID-19 vaccination rates ticking up as Delta fuels infections

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The rate of vaccination in the U.S. continues to tick upward. On Aug. 1, healthcare workers administered 816,203 doses, marking one of the highest totals in recent weeks.

Vaccination rates have increased about 24% in the past week, according to an estimate from UBS.

If the trend holds, the daily vaccination rate could surpass one million — roughly in line with the pace in late June.

At present, almost 58% of all Americans have received at least one COVID-19 vaccine dose.

In early July, the daily rate of U.S. vaccinations hit its lowest point since the beginning of the year. At that time, health officials administered about 500,000 doses daily.

As a result of the lagging vaccination rate, the U.S. was about a month late in meeting President Biden’s goal to provide at least one vaccine dose to 70% of adults by July 4. Some 60.6% of U.S. adults are fully vacc…

FDA responds to pressure to approve COVID-19 vaccines

Health experts have insisted that the FDA accelerate the approval process for COVID-19 vaccines, starting with the Pfizer-BioNTech vaccine. The agency will reportedly begin a “sprint” initiative to accelerate its approval of that vaccine, which was the first to win emergency use authorization, according to multiple media outlets, including The Wall Street Journal.

New COVID-19 vaccinations continue to flag, although they have recently increased slightly with the rise of the Delta SARS-CoV-2 variant.

In early May, Pfizer Inc. (NYSE:PFE) and BioNTech SE (NSDQ:BNTX) began the rolling submission process with the FDA for a Biologics License Application (BLA) for their COVID-19 vaccine. On June 1, Moderna (NSDQ:MRNA) reached the same milestone.

In early July, FDA granted priority review to the Pfizer-BioNTech vaccine.

The agency has cleared the Pfizer-BioNTech and Moderna vaccines under its emergency use authorization program.

The lack of full FD…

Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

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

Pfizer highlights COVID-19 and flu vaccine strategy in Q2 earnings call

With vaccines generating a significant portion of Pfizer’s (NYSE:PFE) revenue in the first six months of 2021, the company shed light on its vaccine plans in its most recent quarterly earnings call.

While the company recently won FDA approval for its potential blockbuster pneumococcal 20-valent vaccine, its mRNA vaccine strategy understandably took center stage during the Q2 call yesterday.

Pfizer working on an mRNA flu vaccine

Pfizer began working with BioNTech (NSDQ:BNTX) to develop an mRNA-based flu vaccine in 2018. The mRNA platform could boost flu vaccine efficacy and lead to a better immune response. Traditional flu vaccines are between 40% and 60% effective among the overall population, according to the CDC.

The company aims to launch human trials for a modified RNA flu vaccine in the third quarter of the year.

Delta variant concerns

Pfizer is currently running a clinical trial to test the use of a third dose of its vaccine six to 12 months…

Preprint shows strong but fading efficacy of Pfizer vaccine at six months

An ongoing study involving the BNT162b2 COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could potentially underscore the need for boosters. But more data are needed to understand vaccine performance over time, according to a preprint published on MedRxiv.

Pfizer CEO Dr. Albert Bourla has previously predicted that booster doses of the vaccine would be needed. Still, the U.S. government has yet to embrace that view for the general population. A CDC advisory committee, however, recently endorsed the use of boosters in immunocompromised patients.

The study found that the efficacy of the BNT162b2 vaccine peaked between seven days to less than two months after the administration of the second dose. Four-to-six months after the second dose administration, the efficacy waned to 83.7%. Efficacy declined an average of roughly 6% every two months, according to the paper. “Ongoing follow-up is needed to understand persistence of the vaccine effect over tim…

Pfizer and Moderna to expand clinical trials for school-aged children

As a result, Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) have agreed to expand clinical trials of their vaccines in children aged five to 11 before seeking emergency use authorization.

In April, Israel first reported suspected cases of heart inflammation in recipients of the COVID-19 vaccine from Pfizer and its partner BioNTech.

Since then, FDA has substantiated the risk of myocarditis, or heart inflammation, from mRNA vaccines, which is rare and tends to be minor.

According to The New York Times, federal regulators concluded that the proposed clinical trials to study the Pfizer and Moderna vaccines in school-aged children were insufficiently powered to detect rare side effects, including heart inflammation.

[Related: AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study]

Pfizer (NYSE:PFE) and BioNTech (NASDAQ: BNTX) announced in June that it was expanding its COVID-19 vaccine trial to include up to 4,…

AstraZeneca, Pfizer Moderna vaccines fare well against Beta, Gamma and Delta variants in study

A recent Canadian pre-print study found that AstraZeneca’s Vaxzevria vaccine was 82% effective in preventing hospitalization or death from the Beta and Gamma SARS-CoV-2 virus variants. Using the same benchmark, its efficacy against the Alpha and Delta variants was 87% and 90%, respectively, 21 days after administering the first dose.

The BNT162b2 vaccine from Pfizer and BioNTech had a similar efficacy after 21 days. In terms of protecting against the Beta and Gamma variants, a single dose of the BNT162b2 vaccine was 83% effective at protecting against hospitalization and death after 21 days. One dose of Moderna’s mRNA-1273 vaccine was 94% effective at the same interval.

A second dose of the Pfizer-BioNTech vaccine boosted its efficacy considerably. It was 98% effective at preventing hospitalization or death from the Beta and Gamma variants 14 days after the second dose. Its protection against other variants was similar following the second dose.

There wa…

Man experiences facial palsy twice after receiving both COVID-19 vaccine doses

Representational Bell’s palsy image courtesy of Wikipedia

The possibility of mRNA causing facial palsy continues to make headlines. A month after a JAMA study found no link between the Pfizer-BioNTech vaccine and facial paralysis, an article in BMJ Case Reports describes the case of a 61-year-old U.K. man who experienced facial palsy episodes after receiving both doses of the Pfizer-BioNTech vaccine.

The journal reports that the case report is the first to describe unilateral facial nerve palsy after both doses of the Pfizer-BioNTech vaccine.

In the Phase 3 trial for the Pfizer-BioNTech vaccine, four patients who received the injection developed Bell’s palsy while none in the placebo arm did. There were approximately 38,000 participants in that study.

In the case of the 61-year-old man, he experienced facial paralysis on the right side five hours after receiving the first dose. The …

Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

[Image courtesy of Wikipedia]Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Get the full story on our sister site Pharmaceutical Processing World.