FDA advisory committee has recommended a booster dose of Moderna’s COVID-19 vaccine
An advisory committee for the U.S. Food and Drug Administration (FDA) has voted to recommend approval of booster doses of Moderna‘s COVID-19 vaccine.
The boosters have only been approved for older adults aged 65 and older and those who are at high risk of developing a severe case of the virus due to underlying conditions and at least six months after the second dose.
It comes almost exactly one month after the Vaccines and Related Biological Products Advisory Committee (VRBPAC) approved boosters for the Pfizer-BioNTech vaccine
Many VRBPAC members lamented that there wasn’t more robust data to support the need for boosters, but others pointed out a precedent had already been set byt approving a third shot of Pfizer.
‘From a pragmatic point of view, because we’ve already approved it for Pfizer, I don’t see how we can possibly not approve it for Moderna,’ Dr Stanley Perlman, a professor in the departments of microbiology and immunology at the University of Iow, said during the meeting.
The FDA’s advisory committee has voted to recommend approval of Covid booster shots of Moderna’s vaccine. Pictured: A healthcare worker holds a vial of the Moderna COVID-19 vaccine in New York City, January 2021
Unlike Pfizer’s booster, which is merely a third dose of its vaccine, Moderna’s booster is a 50 microgram (µg) dose – half the dose of its original vaccine.
Previous data has shown the booster increased levels of neutralizing antibodies, including against the original virus and variants, including the Beta and Gamma variants.
The advisory committee also looked at data from Israel, which began administering Pfizer boosters two and-a-half months ago.
The data showed that boosters lowered the number of severe cases in people aged 60 and older by 84 percent from 957 to 150.
Boosters also decreased severe cases by 95 percent each among those aged 18 to 49 from 160 to seven and among those aged 16 to 39 form 23 to one.
Last month, Moderna released data showingpeople who received its COVID-19 vaccine last year are nearly twice as likely to get a breakthrough infection compared to those recently vaccinated.
There were 88 breakthrough cases of COVID-19 among Americans vaccinated from December 2020 to March 2021.
Comparatively, there were 162 cases – 1.8 times as many – among those vaccinated between July 2020 and December 2020.
The Cambridge, Massachusetts-based company said the data provided evidence for giving booster doses to fully vaccinated people.
In August, the White House that COVID-19 vaccine booster shots would be rolled out for all Americans starting September 20.
At the time, the Biden administration released studies citing waning immunity and the ability of the Delta variant to cause breakthrough infections.
However, officials at the FDA and Centers for Disease Control and Prevention (CDC) pushed back, saying there wasn’t enough evidence that the efficacy of the vaccines were declining.
During the VRBPAC meeting, the members reiterated that data did not show that the vaccines’ effectiveness was waning, especially in healthy people under age 65.
‘We are seeing cases going down without booster doses and in this population, people who are vaccine appear to be protected,’ said member Dr Archana Chatterjee, an expert in infectious diseases and Dean of Chicago Medical School at Rosalind Franklin University’
‘The disease primarily seems to be occurring in – especially in its most severe form – in the unvaccinated.’
This led to boosters for Pfizer’s vaccine not being rolled out until September 22 – past the targeted roll out date – and only for specific groups, just like Moderna.
Next, Moderna’s booster shot will be need to be authorized by the FDA and approved by the Centers for Disease Control and Prevention’s (CDC) advisory committee.
This is a breaking news story and will be updated.