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US FDA Advisory Limits COVID-19 Booster Doses to Those ‘At High Risk'

The advisory has recommended the US FDA against endorsing COVID-19 booster shots for all citing a lack of evidence.

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US FDA Advisory Limits COVID-19 Booster Doses to Those ‘At High Risk'
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On late Friday, 17 September, a key advisory of the US FDA came to the near unanimous decision against endorsing Pfizer's application for booster doses for everyone over the age of 16.

This decision comes just two days after the FDA released a review of Pfizer's application for approval of its COVID-19 booster shot for the general public– a matter which has been the point of much contention from experts.

In the review, the FDA seemed less than convinced of the need for a third dose of COVID vaccine for the general public, but had not passed any judgement on it, leaving it up to an external advisory of experts from various US health bodies including the CDC (Centre for Disease Control and Prevention) and NIH (National Institute of Health), to make their recommendation

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The advisory now has given its verdict, maintaining that booster shots may be taken by those over the age of 65 and others who are at 'high risk' (such as immunocompromised people, cancer patients etc).

However, the advisory has voted against the need for booster shots in everyone over the age of 16. They argue that there isn't enough evidence to justify the move.

“It’s unclear that everyone needs to be boosted, other than a subset of the population that clearly would be at high risk for serious disease."
Dr Michael G. Kurilla, a committee member and official at the National Institutes of Health, as quoted by the New York Times

3 Key Reasons for the Advisory's Decision

Let's break down the advisory's recommendation, and the main reasons they've cited for recommending against universal COVID-19 booster doses.

1. Not enough evidence

The advisory panel said that the data submitted by Pfizer along with other studies conducted elsewhere prove that two doses of the COVID-19 vaccine protects against severe illness and fatality even with more infectious variants such as the Delta Variant.

Speaking to FIT for a different article, epidemiologist Dr J P Muliyil explained this saying, "What they (the vaccine companies) promised was the vaccine will prevent serious infection and that they're doing that. Booster doses are being taken to prevent infection, and in my opinion that won't work."

The US FDA has on previous occasions also expressed that it is unconvinced of the data supporting the need for a booster shot, saying it may be too soon to allow boosters just yet.

2. Impact on younger people

The advisory panel also expressed their scepticism when it comes to the impact the booster will have on young people.

"We're being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence the third dose for a younger person, when compared to an elderly person, is of value," Dr Paul Offit, committee member and a professor of paediatrics at the Children's Hospital of Philadelphia, was quoted by CNN Health as saying at the meeting.

"If it's not of value, then the risks may outweigh the benefits. And we know the 16-29-year-old is at higher risk of myocarditis."
Dr. Paul Offit, a professor of pediatrics at the Children's Hospital of Philadelphia, as quoted by CNN Health

3. Must vaccinate all before 'boosting' some

The advisory committee members also stand by the argument that the focus currently should be on increasing the vaccine coverage and ensuring most people receive both the doses, before some people are given a third booster dose, unless they are especially vulnerable.

“We all agree that if we really want to impact this pandemic, we need to vaccinate the unvaccinated,” Offit was quoted by the New York Times, as saying at the meeting.

Room For Change in Policy Remains

It must be noted that the external advisory's reccomendation, is just that, a reccomendation, and the final call remains with the US FDA who may or may not take the advisory's advise.

The advisory panel has also not clearly defined the parameters of what qualifies as 'high risk', leaving room for millions of Americans to qualify for the booster dose.

Things are likely to get clearer when the US FDA announce its decision, which is said to happen by next week, according to the New York Times.

(Written with inputs for the New York Times, and CNN Health.)

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