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FDA advisers back Covid shots for kids under 5

The 21-member committee advising the Food and Drug Administration voted unanimously in favor of clearance for Pfizer’s three-dose vaccine for youngsters ages six months through 4 years.

June 16, 2022 / 06:28 IST
A healthcare worker prepares a dose of the Moderna Covid-19 vaccination at Queens Police Academy in the Queens borough of New York, U.S., on Monday, Jan. 11, 2021. New York City Mayor Bill de Blasio reaffirmed his goal of doling out 1 million Covid-19 doses by the end of January.

Covid vaccines for infants and toddlers from Moderna Inc. and Pfizer Inc. won support from a panel of US regulatory advisers, putting parents one step closer to being able to protect their youngest against Covid-19 for the first time.

The 21-member committee advising the Food and Drug Administration voted unanimously in favor of clearance for Pfizer’s three-dose vaccine for youngsters ages six months through 4 years. Earlier Wednesday, it gave the same strong endorsement to Moderna’s two-dose for children six months through 5 years. The FDA doesn’t have to follow the recommendations of its advisory panels, but it usually does.

Authorized vaccines would be welcome news for parents whose youngsters are the last remaining age group with no cleared vaccine. While children are less likely than adults to experience the worst outcomes of Covid, the FDA warned that the rate of hospitalization for children, particularly during the omicron wave, has been “quite troubling.”

The youngest population “has been much less affected than the older populations, particularly the oldest population, but nonetheless has also been affected,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the meeting. “Each child that’s lost essentially fractures a family.”

The US government has already secured a supply of 10 million doses from Pfizer and Moderna to vaccinate under-5s as soon as the FDA and the Centers for Disease Control and Prevention give the green light. The vaccines for the youngest of kids are expected to be rolled out as early as June 21, the Biden administration said earlier this month.

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Advisers to the CDC will hold a two-day meeting later this week to discuss the shots for kids. The panel of outside experts, the Advisory Committee on Immunization Practices, advises the CDC on how best to administer new vaccines. CDC Director Rochelle Walensky will need to sign off on any recommendations before vaccines can begin to be administered.

Bloomberg
first published: Jun 16, 2022 06:28 am

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