BREAKING NEWS: FDA advisory committee has unanimously recommended a booster dose of Moderna’s COVID-19 vaccine for those aged 65 and older and at high risk due to underlying conditions or their jobs
- The FDA’s advisory committee unanimously voted to recommend approval of Covid booster shots of Moderna’s vaccine on Thursday
- Boosters shots will only be approved for those aged 65 and older at high risk due to their jobs or underlying conditions
- It comes one month after Pfizer’s COVID-19 vaccine booster was approved for the same at-risk groups
- Moderna released last month showing people who received its COVID-19 vaccine last year are nearly twice as likely to get a breakthrough infection
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 VRPBAC 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.
Last month, Moderna released data showing people 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.
This lead 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.