COVID-19 vaccines Archives - Page 3 of 24

BioNTech 2021 revenue surges 39x year over year

The mRNA vaccine pioneer (Nasdaq:BNTX) announced fourth-quarter revenue of €5.5 billion and €19.0 billion in revenue for 2021.

Sales of the BNT162b2 COVID-19 vaccine, developed jointly with Pfizer, fueled the revenue growth.

In 2020, BioNTech’s revenues were €482.3 million.

“Looking back, 2021 was an exceptional year during which BioNTech had a momentous impact on human health and the global economy with our first approved vaccine based on our mRNA technology,” said Dr. Ugur Sahin, BioNTech CEO, in a news release.

The company plans on using the recent cash infusion to boost R&D spending by roughly 50%. In all, the company plans on spending between €1.4 billion to €1.5 billion in R&D in 2022.

It seeks to advance various programs, including the development of mRNA-based immunotherapies, cell therapies and bi-specific antibodies. The company will also invest in regenerative medicine and autoimmune diseases.

BioNTech also plans t…

Moderna seeks FDA blessing for second COVID-19 vaccine booster

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) recently asked FDA to allow individuals 65 and older to receive a second booster of their BNT162b2 COVID-19 vaccine.

Now, Moderna (Nasdaq:MRNA) is filing for FDA authorization to permit a fourth dose of its Spikevax (mRNA-1273) COVID-19 vaccine for adults 18 and older.

In its submission, Moderna included data gathered from the U.S. and Israel after the emergence of the omicron variant.

Data on the efficacy of a fourth dose of Moderna’s vaccine against omicron were recently published in NEJM. The researchers, considering data from the Moderna and Pfizer-BioNTech vaccines, concluded that a fourth dose of mRNA vaccine appears to be “immunogenic, safe, and somewhat efficacious (primarily against symptomatic disease).”

In January, early data from Israel’s Sheba Medical Center indicated that an additional booster of COVID-19 vaccine from Pfizer and BioNTech drove to a fivefold increase in antibodi…

Pfizer and BioNTech seeking FDA authorization of fourth COVID-19 vaccine dose for older adults

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application to the FDA for Emergency Use Authorization (EUA) for an additional COVID-19 vaccine booster dose in adults 65 years of age and older.

The two companies submitted two real-world data sets from Israel while the omicron variant was widespread.

Pfizer notes that an additional dose of the BNT162b2 vaccine enhanced protection against infections and severe illness.

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

CDC recommends eight-week interval for some COVID-19 vaccine recipients

The CDC has recommended extending the interval between the first and second doses of the Pfizer (NYSE:PFE) and Moderna (NASDAQ:MRNA) COVID-19 vaccines up to eight weeks for some individuals.

The guidance for those vaccines was formerly 21 and 28 days, respectively.

CDC notes that an eight-week interval could be preferred for some individuals 12 and older — especially males aged 12 to 39. The extended window may reduce the risk of myocarditis.

A three-week interval for Pfizer-BioNTech and a four-week interval for Moderna is preferred for individuals who are moderately to severely immunocompromised and adults who are at least 65.

While myocarditis associated with mRNA vaccines remains rare, passive surveillance reporting in the U.S. confirms an increase in the condition — especially in adolescent males and young men, according to a report in JAMA.

Extending the interval between the first and second doses may result in superior vaccine ef…

FDA reportedly mulling authorizing fourth COVID-19 vaccine dose

[Image courtesy of Wikipedia]

Officials at the Food and Drug Administration are considering potentially authorizing an additional booster of the COVID-19 vaccines from Moderna (NASDAQ:MRNA) as well as Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), according to the Wall Street Journal.

At present, individuals 12 and older who are moderately or severely immunocompromised are eligible for four COVID-19 vaccine doses.

Before the FDA allows the broader public to obtain an additional dose, the agency would require data demonstrating the ability of a fourth dose to boost immunity.

At present, however, it remains unclear whether the agency would recommend first-generation vaccines or recommend a variant-specific version.

Pfizer, BioNTech and Moderna are working on omicron-based boosters.

CDC currently recommends all individuals who are at least 12 to obtain three doses of mRNA COVID-19 vaccine…

FDA could authorize Pfizer-BioNTech vaccine for young children in late February

The FDA has requested that Pfizer apply for emergency authorization for the BNT162b2 vaccine for children 6 months of age to 5 years old, according to media reports.

The agency is awaiting data from a third dose of the vaccine in the age group, which could be available in March.

Pfizer could apply for emergency use authorization as soon as tomorrow and win authorization by the end of February, according to The Washington Post.

In December, Pfizer and its partner BioNTech (NSDQ:BNTX) announced that an independent data monitoring committee concluded the study met non-inferiority requirements for the 6- to 24-month-old group but not for the 2- to under 5-year-old group.

The vaccine was well tolerated in the young age group.

Recipients in the trial are receiving 3 µg doses of mRNA, which is one-tenth the amount used in adults.

For 5- to 12-year-olds, the authorized dose is 10 µg.

The first two doses are administered 21 days…

WHO concludes that updated COVID-19 vaccines may be needed

When confronting an onslaught of new SARS-CoV-2 variants, COVID-19 vaccine makers such as Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have tested tweaked versions of their vaccines but ultimately decided that they were unnecessary.

Signs are growing that vaccines developed based on the original strain of the novel coronavirus will struggle to offer durable protection against the omicron variant.

A World Health Organization (WHO) technical advisory group concluded that current COVID-19 vaccines might require modification but acknowledged that more research is needed.

In an interim statement, the independent group also concluded that “a vaccination strategy based on repeated booster doses of the original vaccine composition is unlikely to be appropriate or sustainable.”

The body also urged that governments worldwide ramp up the distribution of current COVID-19 vaccines.

The WHO advisory panel also predicted there were multiple pathways for drug…

7 potential applications of mRNA-based therapeutics

mRNA image courtesy of Wikimedia Commons.

Scientists have experimented with mRNA for decades, but the pandemic foisted the platform into the limelight. The Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) COVID-19 vaccines have since emerged as two of the best-selling pharmaceutical products in recent memory.

Researchers are now exploring dozens of new possibilities for the mRNA platform.

Here, we summarize several areas where mRNA could find use in the coming years.

1. Cardiovascular applications

Image by Raman Oza from Pixabay

Researchers at the University of Pennsylvania recently shared positive data related to the use of mRNA and CAR-T cell therapy to treat cardiac fibrosis in a mouse model.

Last year, AstraZeneca (LON:AZN) announced positive results from a Phase…

Israeli researchers release data on fourth dose of COVID-19 vaccine

Photo by cottonbro from Pexels

Early data from Israel’s Sheba Medical Center showed that an additional booster of COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) led to a fivefold increase in antibodies one week after receipt of the vaccine.

Pfizer had earlier announced that a third dose of the vaccine increased antibody levels 25-fold compared to a two-dose primary series.

Pfizer and BioNTech, along with their competitor Moderna (NSDQ:MRNA), continue to develop an omicron-specific version of their mRNA vaccine.

The prospect of a fourth dose of the original vaccine for immunocompetent people may be more controversial than a third.

While Israel has begun administering a fourth dose to some individuals, the head of the French vaccination program, Dr. Alain Fischer, said there was insufficient evidence at present to recommend an additional vaccine dose. France could dec…

Walter Reed research arm’s pan-coronavirus vaccine could hold up against omicron

Vaccine candidate image from the Walter Reed Institute of Research

The Walter Reed Army Institute of Research (WRAIR) is planning to announce positive early clinical results related to a novel nanoparticle-based COVID-19 vaccine, according to media reports.

A Phase 1 study involving the vaccine found that it was effective against omicron, other SARS-CoV-2 variants and other coronaviruses, including SARS-CoV-1. That study began in April.

A preclinical study involving nonhuman primates was recently summarized in Science.

The Spike Ferritin Nanoparticle (SpFN) COVID-19 vaccine will be the subject of Phase 2 and Phase 3 studies, according to an article from Defense One.

Ferritin is an iron-carrying protein that forms a 24-unit sphere-shaped particle.

WRAIR Is also testing the ferritin nanoparticle–baed platform for vaccines for influenza and the Epstein-Barr virus.

Walter Reed …

Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations

Photo by Frank Meriño from Pexels

Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public.

Then came delta and then came omicron.

Now Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk of severe disease. Countries such as Switzerland and the U.K. have reduced the window of time for booster eligibility from six months down to four and three months, respectively.

As a result, COVID-19 vaccines from companies such as Pfizer and its partner BioNTech, Moderna and others continue to be a hot commodity.

A number of companies, including Pfizer and Moderna, are also developing omicron-specific versions of their vaccines. Both of those companies are gearing up for clinical trials in early 2022.

Earlier this month, Pfizer CEO Dr. Al…

100-µg booster dose of Moderna’s vaccine increases antibody levels 83 times against Omicron

Moderna (NSDQ:MRNA) is touting preliminary data suggesting that its COVID-19 vaccine booster led to robust antibody increases against the Omicron variant, both at the 50 µg and 100 µg dose levels.

The 50 µg booster dose, which is currently authorized under emergency use authorization, led to a 37-fold increase compared to pre-boost levels 29 days post-boost. A 100 µg booster dose led to an 83-fold increase in the same time window.

The National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center and Duke University Medical Center conducted the research on sera from 20 booster recipients for the mRNA-1273 vaccine at both 50 µg and 100 µg dose levels.

Two doses of the Moderna vaccine, however, did not offer robust protection against Omicron.

Moderna, like Pfizer, is also developing an Omicron-specific vaccine. Moderna’s is known as mRNA-1273.529.

Moderna anticipates to organize clinical trials for the Omicron-based va…