Second COVID vaccine recommended for emergency use in US, FDA says. What to know
A U.S. Food and Drug Administration advisory committee on Thursday recommended the Moderna coronavirus vaccine for emergency use authorization after reviewing and discussing the latest clinical trial data, deciding that the benefits outweigh the risks.
It’s the second COVID-19 vaccine to be recommended for emergency use authorization in the United States.
The first recommendation was made Dec. 10 for the Pfizer vaccine, which the FDA officially authorized for emergency use the next day. States have already started to administer the vaccine to health care workers and nursing home residents.
Like the Pfizer vaccine, Moderna’s candidate requires two doses given about a month apart. Pfizer’s vaccine is authorized to be given to individuals 16 and older, while Moderna’s is recommended to be authorized to be given to people 18 and older.
An FDA “authorization” is not the same as an “approval.” The emergency use authorizations granted to Pfizer and Moderna allow the use of their still “unapproved” vaccines in emergency situations, such as a pandemic, for which “there are no adequate, approved and available alternatives.”
All products with an emergency authorization are required to be proven safe during clinical trials.
It’s unknown when the FDA will approve the COVID-19 vaccines, a process that requires more data collection. The agency said during its online meeting Thursday that Pfizer is considering applying for licensure to become approved sometime in the spring.
‘Favorable safety profile’
Moderna’s Phase 3 clinical trials enrolled more than 30,000 participants, according to a 54-page document of the FDA’s analysis, and “supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA.”
The vaccine had an efficacy rate of 94%, which was similar across age, gender, racial and ethnic groups, and participants with underlying health conditions that increase their risks for severe COVID-19 cases.
The most common side effects included pain around the injection site (92%), fatigue (69%), headache (63%), muscle pain (60%), joint pain (45%) and chills (43%).
Moderna did not report any allergic reactions to the vaccine in its clinical trials.
There were three incidents of facial paralysis, or Bell’s palsy, reported in the group that received the vaccine and one in the group that received a placebo shot, but Moderna says it does not have enough information to confirm the vaccine caused the paralysis.
Overall, side effects were rare and occurred in 1% of the group that got the vaccine and in 1% of the group that got the placebo.
Two health care workers in the same hospital in Alaska experienced allergic reactions minutes after receiving the Pfizer vaccine this week, according to The New York Times. The first person did not have a history of allergies, and it’s unclear if the second person did.
Both have since recovered.
Experts say the occasional allergic reaction is expected as more people get vaccinated.
Infectious diseases experts and vaccine developers say side effects to COVID-19 vaccines and others are normal and a sign a person’s immune system is creating the response needed to protect against severe infection.
The COVID-19 vaccines cannot give someone the coronavirus, health experts say.
They say it’s still possible to contract the coronavirus after being vaccinated.
Safety data will continue to be collected in a clinical trial setting even after the vaccine is administered to Americans in non-clinical settings.
What’s next?
Vaccine distributions are based on a state’s population size, rather than the number of people in groups that are at high risk of infection, McClatchy News previously reported.
The Centers for Disease Control and Prevention recommended that health care workers and residents of long-term care facilities be first in line to get the vaccine. Next are essential workers such as firefighters and corrections officers, and then adults with high-risk medical conditions and those over 65.
After those groups get their shots, vaccine supplies could be ready for the general population sometime in the spring, officials say. By that point, it’s possible there may be more than two authorized vaccines on the market.
AstraZeneca and partner University of Oxford, and the Janssen Pharmaceutical Companies of Johnson & Johnson, both have vaccine candidates in phase 3 clinical trials, the last step before submitting data to the FDA for review.
But the availability of multiple vaccines doesn’t necessarily mean you’ll be able to pick for yourself, as staggered roll-outs, various storage requirements and other unknowns will likely complicate the process.
This story was originally published December 17, 2020 at 1:59 PM with the headline "Second COVID vaccine recommended for emergency use in US, FDA says. What to know."
