Moderna says bivalent COVID-19 boosters could offer more robust protection against variants 

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

The company continues to develop a vaccine known as mRNA-1273.214 with more omicron-specific mutations. That vaccine candidate is now in a Phase 2/3 clinical trial. The company expects data from that trial to be available in the second quarter.

Moderna has published data related to the mRNA-1273.211 candidate as a preprint study in Research Square.

The company continues to bet that its bivalent booster candidate, mRNA-1273.214, will find use as a booster in autumn 2022 in the Northern Hemisphere.

In any event, the mRNA-1273.211 …

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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…

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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…

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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…

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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…

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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…

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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…

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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.<…

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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…

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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…

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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…

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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…

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