Liesl Eibschutz, a Dartmouth University medical student, loads a syringe of Pfizer COVID-19 vaccine before giving the vaccine on the first day people 16 and older get the vaccine at Kedren Health on Thursday, Angeles, California.
Allen J. Cockroaches | Los Angeles Times | Getty Images
The Food and Drug Administration approved Moderna and Pfizer’s Covid-Booster vaccinations for all U.S. adults on Friday, belatedly fulfilling a critical part of the Biden government’s plan to give the general public additional doses as data show that the effectiveness of vaccines deteriorates over time.
Approval comes about two months late – after scientists advising the FDA over the government’s original plans to start distributing boosters to all adults in the week of September 20, citing lack of data to support the government declined the third dose. Acting FDA Commissioner Janet Woodcock also approved the doses without the usual public session to review new data submitted by the companies last week. Moderna only resubmitted its application two days ago. The company announced on Friday morning.
“This emergency clearance comes at a critical time as we enter the winter months and face rising COVID-19 cases and hospitalizations across the country,” said Stéphane Bancel, CEO of Moderna, in a statement.
The Centers for Disease Control and Prevention has yet to approve the distribution of the booster doses before people can start the vaccinations, which could start this weekend. The CDC’s independent panel of vaccine experts is due to meet on Friday to review the new data. CDC director Rochelle Walensky said Wednesday the health agency would “act quickly” after the FDA clears the shots.
The FDA originally met in September to consider approving Pfizer’s boosters for the general public, but decided against it because some experts feared there wasn’t enough data. Instead, they recommended a reduced distribution plan for the elderly and adults at high risk from Covid. The CDC approved booster shots for these groups earlier this month.
The wide distribution of booster vaccinations is controversial among health authorities. The World Health Organization has criticized rich nations for introducing third vaccinations when people in poorer countries have very limited access to Covid vaccines.
WHO has urged greater focus on supporting vaccination efforts in developing countries, warning that new variants of the virus may emerge and undermine protection in countries that have already reached high levels of vaccination.
Booster shots have also created some controversy in the US, as they are introduced at a time when the country is struggling to convince millions of people to even get their first dose. More than 60 million Americans remain unvaccinated.
However, many Americans want extra protection as data increasingly shows that vaccines become less effective against infection over time. A study published this month in Science magazine found that the effectiveness of Pfizer’s vaccine, which was made with German biotech company BioNTech, decreased from 86% to 43% from February to October this year. The effectiveness of Moderna against symptomatic infections decreased from 89% to 58% and that of Johnson & Johnson from 86% to 13%.
However, the vaccines still offer high levels of protection against hospitalization and death, scientists say.
Public health experts expect Covid infections to spike as the weather changes and Americans gather indoors for the holidays and escape the winter chill. Booster doses could help reduce what is already high transmission by preventing breakthrough infections in people who have already been vaccinated, scientists say.
The CDC has already approved booster doses for people 18 years and older who received the single dose from J&J. Moderna resubmitted its application to the FDA on Wednesday for approval of a third dose of its shot for adults ages 18 and older.
The US has administered more than 169 million doses of Moderna vaccine and more than 258 million doses of Pfizer vaccine. Health officials have administered more than 16 million doses of Johnson & Johnson’s vaccine.
Nearly 80% of Americans 12 and older have received at least one dose of the three vaccines, according to CDC data. More than 31.4 million people in the US have already received their booster vaccinations, the data shows. President Joe Biden received his booster dose in September.
The Senior Medical Advisor to the White House, Dr. Anthony Fauci, on Wednesday urged Americans to get vaccinated and sign up for their booster vaccinations if they are eligible.
“It’s not too late yet. Get vaccinated now. And most importantly, if you were vaccinated six months or more ago and are eligible for a booster, you will be given a booster, ”said Fauci. “The Israelis have shown that if you increase the dose, the chances of getting infected, getting sick or dying are reduced many times over.”
