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Pfizer and BioNTech file for FDA authorization of COVID-19 vaccine boosters for all adults

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) have filed paperwork with FDA to authorize their COVID-19 vaccine for all adults 18 and older.

The two companies had filed a supplemental Biologics License Application for a booster dose of the COVID-19 vaccine in adults at least 16 years old.

FDA did not accept the supplemental Biologics License Application, however. Instead, FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine in September to allow individuals with an elevated risk to receive a single booster dose. The EUA required that eligible individuals receive a booster dose at least six months after completing the primary series.

Earlier, an advisory committee had decided there was insufficient evidence to warrant approval for all adults. In particular, the committee expressed concerns about the rare risk of myocarditis in some younger vaccine recipients.

Instead, the U.S. authorized Pfizer booster doses in October for adults 6…

U.S. to buy 1.4 million additional courses of molnupiravir

Merck (NYSE:MRK) and Ridgeback Biotherapeutics appear to be gaining growing support for their oral COVID-19 therapy molnupiravir.

One week after Great Britain granted conditional marketing authorization for the drug, the companies announced that the U.S. government intends to purchase 1.4 million additional medicine courses for approximately $1 billion.

The U.S. has committed to buy approximately 3.1 million molnupiravir courses for $2.2 billion, which equates to about $710 per course.

For the sake of comparison, the U.S. pays about $40 per dose of COVID-19 vaccines.

Molnupiravir photo courtesy of Merck.

The U.S. has the option of buying an additional 2 million courses of molnupiravir.

Merck and Ridgeback are awaiting news from FDA regarding their submission for emergency use authorization of molnupiravir. The application would cover adults with mild-to-moderate COVID-19 who have …

Pfizer’s COVID-19 pill reduced risk of hospitalization or death by 89%

Until recently, there were no oral treatments against the novel coronavirus. Molnupiravir, an oral antiviral from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, recently won approval in the United Kingdom and is poised to find use in other countries.

And Pfizer (NYSE:PFE) has now announced that its oral antiviral cut the risk of hospitalization or death by 89% in an interim analysis of the Phase 2/3 EPIC-HR trial.

Merck had announced that molnupiravir led to an approximately 50% reduction in hospitalizations and deaths versus placebo.

The Pfizer EPIC-HR trial study found that 0.8% of patients who received Paxlovid were hospitalized within 28 days. There were no deaths in the drug group. Conversely, 7% of placebo recipients were either hospitalized or died.

Based on feedback from the independent Data Monitoring Committee and FDA, Pfizer will stop enrollment in the study.

The company also plans on filing data from the trial with the FDA as p…

CDC panel backs Pfizer’s COVID-19 vaccine for 5- to 11-year-olds

The Comirnaty vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) could soon be available for children between the ages of 5 and 11, now that the Advisory Committee on Immunization Practices (ACIP) unanimously recommended its use.

The members of the CDC have “a lot of enthusiasm for this vaccine in this age group,” said Dr. Beth Bell, an ACIP member and professor at the University of Washington.

CDC Director Dr. Rochelle Walensky will likely formalize the use of the vaccine at the 10-μg dose level, which is one-third as much as the amount in the version for individuals 12 and up.

Earlier this week, the White House signaled that the federal government had acquired enough Pfizer vaccine for all children aged 5 to 11.

The federal government plans to partner with a network of schools, pediatricians, family doctors and other facilities to administer the vaccine.

In a Pfizer Phase 3 trial, the vaccine had 91% efficacy against symptomatic COVI…

Pfizer projects $36 billion in COVID-19 vaccine revenue in 2021

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) continue to dominate the COVID-19 vaccine market.

In 2021, Pfizer anticipates that the Comirnaty (BNT162b2) vaccine will generate $36 billion in sales.

For the sake of comparison, the company’s overall 2020 revenue was $41.9 billion.

The vaccine was the single biggest driver of revenue for the company in the third quarter, which totaled $24.1 billion overall. Compared to the same quarter last year, revenues increased 130%. Excluding Comirnaty sales, revenues grew 7% year over year.

Earlier this year, Pfizer projected that sales of the vaccine would be in the ballpark of $33.5 billion.

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

Pfizer CEO Dr. Albert Bourla stressed that the global nature of its COVID-19 vaccine sales growth. “For example, more than 75% of the revenues we have recorded up through thir…

FDA delays EUA decision for Moderna vaccine in teens

Moderna (NSDQ:MRNA) saw its share price fall 5% in mid-day trading today after the FDA said it would delay authorizing its mRNA-1273 vaccine in 12- to 17-year olds.

The agency said it needed additional time to investigate the risk of myocarditis in younger vaccine recipients.

FDA informed Moderna that it may not complete its review before January 2022.

Cambridge, Massachusetts–based Moderna’s recent emergency use authorization (EUA) request involved a 100-µg dose of mRNA.

FDA has issued emergency use authorization for the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) vaccine for adolescents 12 to 17 at the 30-µg dose level.

FDA recently authorized the use of that vaccine in children between the ages of 5 and 11, albeit at a lower 10-µg dose level.

Moderna intends to request an EUA of its mRNA-1273 vaccine involving two 50-µg doses in children aged 6 to 11. The company, however, has delayed that request as FDA performs its myocarditis review.<…

FDA OKs Pfizer-BioNTech COVID-19 vaccine for children aged 5 to 11

The FDA has expanded vaccine eligibility to include children at least 5 years old.

Earlier this week, the agency’s Vaccines and Related Biological Products Advisory Committee concluded that the benefits of the Pfizer-BioNTech (NYSE:PFE/NASDAQ:BNTX) for children 5 to 11 outweigh the risks. The recommendation pertained to two 10-µg doses of the vaccine, which is one-third of the dose used in individuals 12 and up.

A total of 17 out of 18 of the VRBPAC’s members voted in favor of expanding the vaccine eligibility.

FDA noted that it based its decision on a range of data, including a study that enrolled roughly 3,100 children in the relevant age group. The study found that the vaccine was 90.7% effective at preventing symptomatic COVID-19.

“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” Acting FDA Commi…

Pfizer to provide 50M COVID-19 vaccines for U.S. children

Doses of the COVID-19 vaccine are seen at Walter Reed National Military Medical Center, Bethesda, Md., Dec. 14, 2020. (DoD photo by Lisa Ferdinando)

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. bought 50 million more doses of its COVID-19 vaccine.

The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children.

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

Pfizer to provide 50M COVID-19 vaccines for U.S. children

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

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. bought 50 million more doses of its COVID-19 vaccine.

The U.S. purchased the additional doses of the vaccine in its effort to support preparedness for pediatric vaccinations as it seeks authorization for use in younger adolescents and children.

Earlier this month, Pfizer submitted a request to the FDA to expand the authorization of their COVID-19 vaccine, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received emergency use authorization (EUA) for adolescents aged 12 to 15 in May.

Last week, the company announced that the vaccine was 90.7% effective at protecting against symptomatic COVID-19 in children ages 5 to 11 and, earlier this week, FDA’s Vaccines …

CDC authorizes fourth COVID-19 vaccine dose for some immunocompromised patients

As a growing number of Americans become eligible for a third dose of COVID-19 vaccines, CDC continues to expand its booster guidelines.

The agency has amended its criteria for moderately to severely immunocompromised people to allow a fourth dose of COVID-19 vaccine six months after receiving the third dose.

The criteria pertain to immunocompromised individuals who are 18 years of age or older who have received three doses of an mRNA vaccine.

CDC will allow COVID-19 vaccines from Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX), Moderna (NSDQ:MRNA) or Janssen (NYSE:JNJ) for the fourth dose. For Moderna recipients, the guidance recommends a 100-µg dose of mRNA for the third dose and a 50-µg dose for the fourth.

The guidelines, however, are more overt in their recommendations for moderately or severely immunocompromised individuals who have only received two doses of an mRNA vaccine. Assuming at least 28 days have elapsed since the second dose, CDC recommends t…

VRBPAC panel votes in favor of Pfizer-BioNTech vaccine for 5- to 11-year-olds

FDA’s Vaccines and Related Biological Products Advisory Committee has endorsed the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine for children 5 to 11.

A total of 17 voted in that the vaccine’s benefits outweighed the risk in the age group.

VRBPAC member Dr. Michael Kurilla, the director of NIH’s Division of Clinical Innovation, abstained from voting.

Kurilla had advocated that children with a prior COVID-19 infection receive alternate dosing.

The committee based its conclusions on data from Pfizer, which found that two 10-µg doses of the vaccine were generally well tolerated and 90.7% effective against COVID-19. Pfizer also provided some immunobridging data.

Before the vaccine is available for children in this lower age group, FDA and CDC will need to issue formal recommendations concerning its use in children 5 to 11. There are roughly 28 million children in that age group in the U.S.

Several panelists said they were less wo…

Moderna releases positive interim Phase 2/3 COVID-19 vaccine data for children 6 to 11

Moderna (NSDQ:MRNA) said two 50-μg doses of its mRNA-1273 vaccine fared well in a planned interim analysis of the Phase 2/3 KidCOVD study involving children between the ages of six and 11.

Last week, rival vaccine maker Pfizer (NYSE:PFE) announced that two 30-μg doses of the BNT162b2 vaccine were 90.7% against COVID-19 in a study involving children aged five to 11.

Moderna did not release interim efficacy numbers. Instead, it announced that two doses of its vaccine led to antibody levels 1.5 times higher in children than those it found in young adults in the Phase 3 COVID-19 study.

Moderna also reported that the shots were generally well-tolerated in the age cohort, which had 4,753 participants.

Side effects were similar to those found in adults, including fatigue, headache, fever, and injection-site pain most frequently.

The company reported that the study met its primary endpoint and that it would submit the data to FDA and other regulato…