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FDA clears Moderna and Pfizer-BioNTech bivalent COVID-19 boosters in children

The FDA has amended emergency use authorizations (EUAs) for the bivalent COVID-19 vaccine boosters from Moderna (Nasdaq:MRNA) and Pfizer (NYSE:PFE) to allow their use in children at least five years old.

FDA authorized a single dose of either bivalent vaccine in younger age groups at least two months after completion of primary or booster vaccination.

MRNA shares were up 8.28% to $130.72. PFE shares were mainly flat, holding steady at $42.03. BioNTech, which worked with Pfizer in developing the original and updated mRNA vaccine, saw its stock increase 5.53% to $136.65.

The bivalent vaccines from Moderna and Pfizer-BioNTech include an mRNA component shared between the omicron variant BA.4 and BA.5 lineages.

FDA’s decision to authorize the bivalent Pfizer-BioNTech COVID-19 vaccine booster overrides its prior authorization of the companies’ monovalent booster in children aged five to 11.

The revised Moderna authorization will make its 25 μg bi…

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…

Why COVID-19 booster criteria will remain complicated for now

The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated.

Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility.

The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or more after the first.

The Pfizer-BioNTech and Moderna boosters are available to fully vaccinated people 65 or older, provided six months have elapsed after receipt of the last dose. In addition, individuals 18 and older who live in a long-term care facility are also eligible. Those who live or work in high-risk settings also can get the shot, as can individuals with certain medical conditions.

When asked when FDA would authorize boosters to all individuals 18 and older, Dr. Peter Marks, a senior official at FDA, said in a media briefing, “I think we may get…

FDA appears to be lukewarm on Moderna COVID-19 vaccine boosters

To date, FDA has been cautious in its consideration of COVID-19 vaccine boosters. Now, the agency seems to be staying the course.

In a recently published document summarizing its current view of Moderna’s booster application, the agency concluded that Moderna had not met all of its criteria for authorization.

Rather than taking a position, the agency was ambivalent in its references to Moderna’s (NSDQ:MRNA) request. While a third dose led to higher antibody levels, it did not meet the endpoint of increasing antibody levels sufficiently across a high percentage of study volunteers. Although 88% of recipients had an at least four-fold increase in neutralizing antibody titers with a booster, their seroresponse rate “did not meet the pre-specified immunobridging success criterion,” the FDA document noted.

Moderna’s application asked the agency to authorize boosters for the same populations now eligible for an additional dose of the Pfizer-BioNTech vaccine: a…

Moderna submits initial data to FDA for COVID-19 vaccine booster

Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine.

Cambridge, Massachusetts-based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg dose level.

The company amended the Phase 2 study of the mRNA-1273 vaccine to offer a booster dose at the 50 µg dose level to interested participants (344 in total) at six months after receiving their second dose as neutralizing antibody titers had waned significantly prior to boosting at approximately six months.

A booster dose of the vaccine boosted neutralizing titers significantly above the Phase 3 benchmark and, after a third dose, a similar level of neutralizing titers was achieved across age groups, notably in older adults 65 and above. The safety profile was similar to that observed previously for the second dose an…

COVID-19 vaccine booster questions remain

Image from Nataliya Vaitkevich via Pexels

While the question of when the vaccinated public will require a COVID-19 booster remains unclear, some long-term care advocates are pushing for guidance to avoid a potential resurgence in infections in the fall and winter.

Nursing home residents were among the first to receive COVID-19 vaccines. Providing boosters to the demographic is vital to prevent the spread of COVID-19 infections, which was a significant driver of overall mortality from the novel coronavirus at the beginning of the pandemic. “Hence, if and when the residents’ immunity wanes, we must be on high alert, lest we relive the horrors of the past year,” said Dr. Mike Wasserman, a member of California’s Vaccine Advisory Committee in an interview with ABC News.

Complicating matters is the fact that many older adults have a diminished ability to produce antibodies, increas…