COVID-19 vaccines Archives - Page 5 of 24

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…

Moderna pursues EU authorization of its COVID-19 vaccine in children aged 6 to 11

Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union.

Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union.

Last week, the company announced that FDA had delayed its review of the mRNA-1273 vaccine in 12- to 17-year-olds to investigate reports of myocarditis apparently linked to the vaccine.

EU regulatory authorities have not yet authorized a COVID-19 vaccine for children younger than 12. The Austrian capital of Vienna, however, will begin vaccinating young children against the novel coronavirus on November 12.

Cambridge, Massachusetts–based Moderna has an ongoing Phase 2 trial, dubbed “KidCOVE,” investigating the use of its vaccine in children as young as 6 months of age.

The company reports that vaccine efficacy — measured as protection against sympt…

States sue to block COVID-19 vaccine mandate

Image courtesy of Unsplash

The attorneys general in 26 U.S. states are opposing the Biden administration’s plan to force many employers to require their workers to obtain vaccination against COVID-19.

While the majority of states were Republican-led, Kansas, Louisiana and Kentucky were three Democratic-leaning states that joined the litigation.

White House spokeswoman Karine Jean-Pierre said in a media briefing that the vaccine mandates have a firm legal footing.

The vaccination mandate threatens penalties of almost $14,000 per infraction.

The federal government intends to begin enforcing the rules on January 4.

The rules are more stringent for healthcare facilities receiving funding from Medicare and Medicaid. In such facilities, eligible staff must receive at least one vaccine dose before providing healthcare, treatment or other services by December 5.

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…

Biden’s COVID-19 vaccine mandate goes into effect

President Biden first signaled his intent to require many American workers to obtain full vaccination against COVID-19 in September.

Now, a significant number of employers must ensure their workers are either vaccinated or tested weekly for COVID-19 by January 4 as the rules become official. The requirements will apply to employers with at least 100 employees, translating to approximately 84 million workers.

At present, roughly two-thirds of Americans have received at least one dose of a COVID-19 vaccine, and just over 58% of the U.S. public is fully vaccinated, according to CDC. In addition, about one in ten people have received a booster dose.

Several other countries have substantially higher vaccination rates, including the United Arab Emirates, Portugal, Spain, Israel, Singapore, Japan and Canada.

The federal requirements also enable workers to receive paid time off to obtain vaccine doses and sick time to deal with side effects.

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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…

Sanofi is banking on low-cost COVID-19 vaccine

Sanofi (NSE:SANOFI) and its partner GSK (NYSE:GSK) are hoping the low price of their experimental COVID-19 vaccine will stoke interest.

In a call with analysts, Thomas Triomphe, head of the Sanofi Pasteur vaccines division, said that its vaccine would cost less than $10 per dose.

The company is also upbeat about the vaccine’s prospects as a booster.

A Phase 2 trial is currently underway to evaluate its use as a booster. Sanofi has a Phase 3 trial in the works to test its overall safety and efficacy.

The investigational vaccine uses a recombinant protein platform.

Last month, the company scrapped its plans to pursue the development of an mRNA COVID-19 vaccine. Instead, it will continue researching mRNA vaccines that could “address future pandemics and other infectious diseases and therapeutics where there is a strong unmet need,” it announced.

In its Q3 earnings announcement, the company announced that vaccine sales grew 16.5% year ov…

Merck projects at least $5B in 2022 sales for molnupiravir

Merck’s (NYSE:MRK) investigational oral COVID-19 drug could net between $5 billion and $7 billion in revenue through the end of 2022 if FDA authorizes its use in December, the company projected.

Sales of the drug could be higher, assuming it finds widespread use in wealthy countries.

Merck expects sales between $500 million and $1 billion for 2021.

Merck’s stock climbed more than 5% per share to $85.70 in mid-day trading.

Several other companies are also developing COVID-19 antivirals, including Pfizer and Novartis. Roche and Atea recently announced disappointing Phase 2 results involving their investigational antiviral AT-527.

Merck also announced that the molnupiravir, which it developed with Ridgeback Biotherapeutics, would be available in developing countries. To that end, Merck agreed to a royalty-free license for molnupiravir with the Medicines Patent Pool. As a result of the arrangement, generic drug manufacturers could sell a five-d…

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…