The FDA advisory committee has approved Moderna COVID-19 booster shots in those aged 65 or above and other high-risk individuals.
The emergence of various coronavirus variants has led to an increase in breakthrough infections among vaccinated individuals. Moreover, a majority of the breakthrough cases occur in vaccinated immunocompromised individuals. Therefore, vaccine manufacturers have pushed for a booster dose in high-risk individuals, to prevent infections and hospitalizations. A few weeks ago, the US Food and Drug Administration (FDA) approved the use of Pfizer booster shots in the elderly and high-risk individuals. Now, the FDA advisory committee has unanimously recommended Moderna booster shots in people aged 65 or above, and those at higher risk of infection.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) announced its decision in a recent press release. The committee’s recommendation is based on the vaccine’s phase 2 study that administered a 50 µg booster dose of the vaccine to participants. They administered the booster dose 6-7 months after the participant’s second dose. Results of the study showed a significant antibody response in the recipients, especially in those aged 65 years and above. Moreover, the side effects were similar to those observed following the second dose of the vaccine.
This positive recommendation is supported by data on the 50 µg booster dose of our COVID-19 vaccine, which shows robust antibody responses against the original virus, but also against the Delta variant.
Stéphane Bancel, Chief Executive Officer of Moderna
FDA to Vote on Committee’s Recommendation
The FDA will now make its final decision. Although the regulatory authority does not always follow the committee’s recommendation, experts are predicting a positive outcome. An approval of Moderna boosters will help increase the number of available vaccines. Moreover, it can likely decrease the number of breakthrough infections in the country.
The advisory committee recommends the booster shot to people aged 65 or above, adults at high risk of severe disease, and frontline healthcare workers.
We do need to account for the fact that mild to moderate COVID-19 can be associated with adverse outcomes such as blood clots and long COVID-19, even in those who have breakthrough infections.
Dr Peter Marks, FDA
After FDA’s final decision, a CDC panel will next vote whether to approve the booster shot or not. Once the vaccine receives a CDC endorsement, shots will immediately become available to eligible people. The FDA will also make a decision regarding booster shots of the Johnson & Johnson COVID-19 vaccine.
Source:
US Food and Drug Administration (FDA)
