COVID-19 vaccine booster authorized by FDA, CDC for all adults 18+

Tens of millions more fully vaccinated Americans are now eligible for a third shot

Signage is seen outside of FDA headquarters in White Oak, Maryland. (photo credit: REUTERS)
Signage is seen outside of FDA headquarters in White Oak, Maryland.
(photo credit: REUTERS)

The US Food and Drug Administration and the Centers for Disease Control and Prevention have expanded the Emergency Use Authorization of the Pfizer and Moderna coronavirus booster doses for all people over the age of 18.

The 30-microgram Pfizer booster and the 50-mcg Moderna booster are to be administered six months or more after a person received two doses of the Pfizer, Moderna or another approved vaccine. It can also be given as early as two months after the one-dose Johnson & Johnson jab.

"CDC continues to encourage the 47 million adults who are not yet vaccinated to get vaccinated as soon as possible to protect themselves, their families, loved ones and communities," the CDC said in a statement. "We also strongly encourage those who were already eligible – older populations and individuals with underlying medical conditions -- to get boosted before the holidays."

The US voted in September to give booster shots to adults 65 and older, as well as individuals who had a high risk of contracting COVID-19 or developing severe disease. However, at the time – and despite data provided by Israel which had launched a population-wide booster campaign in August – American health officials felt they did not yet have enough data to approve the third shot for the rest of the population.

So far, well over 20 million Americans have received booster doses, according to the CDC.

Pfizer CEO Albert Bourla introduces US President Joe Biden as the president toured a Pfizer manufacturing plant producing the coronavirus disease (COVID-19) vaccine in Kalamazoo, Michigan, US, February 19, 2021. (credit: REUTERS/TOM BRENNER)Pfizer CEO Albert Bourla introduces US President Joe Biden as the president toured a Pfizer manufacturing plant producing the coronavirus disease (COVID-19) vaccine in Kalamazoo, Michigan, US, February 19, 2021. (credit: REUTERS/TOM BRENNER)

The decision does not require a booster shot but makes clear that certain adults should get the third jab and any adult may get it.

“As we near the two-year mark in our fight against COVID-19, we have reached another critical milestone with the expanded authorization of a booster dose of our COVID-19 vaccine in individuals 18 years and older,” said Pfizer CEO Albert Bourla. “With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic.”

LAST MONTH, Pfizer released topline results from its booster dose, which was administered to more than 10,000 people over the age of 16 in the US, Brazil and South Africa. All trial participants had previously received two doses of the company's coronavirus vaccine. The study showed that the booster shot brought vaccine efficacy back up to 95% when compared to those who received a placebo. 

Several studies done in Israel and abroad, including in the United States, have shown that the Pfizer vaccine starts to wane at around four to six months, providing less protection against contracting the coronavirus. 

A study published this month by researchers from KI Institute and KSM Research and Innovation showed that people vaccinated with two shots of the Pfizer vaccine in January and February had a 51% increased chance of contracting the virus in July compared to those who were vaccinated in March or April. That study was published in Nature Communications.

In Israel, more than four million people have already received a third shot. The country decided at the end of the summer to give the booster to everyone over the age of 12 after a Delta variant outbreak caused infection rates to climb. The third shot quickly brought down morbidity and reduced the number of serious cases in Israel’s hospitals.

PFIZER REPORTED last month that the side effects of the third shot were found consistent with the first two and there were no new safety concerns. A separate survey conducted by Maccabi Health Services in September found that among 9,222 individuals over the age of 18 (41% men and 59% women), the majority of whom experienced some side effects from the vaccine, they usually went away within one to three days and none of them were life-threatening.

Half the people surveyed said the side effects were worse for the third shot than the second, and the other half said they were the same or not as bad. Some 57% reported weakness and fatigue, 36% headache, 26% muscle pain, 19% swelling of their lymph nodes, 14% joint pain, 18% a fever of up to 38°C and 9% a fever over 38°C. Some 27% said they had no general side effects.

Israel was the first country in the world to approve the booster for individuals eligible at the time for a two-shot regime. Less than a handful of other countries have approved mass booster campaigns. Most, as per the recommendation of the World Health Organization, have only continued to provide the extra jab to the oldest and most at-risk members of their populations. 

On Friday, Britain’s Department of Health and Social Care announced that travelers who have had a booster or a third dose will be able to demonstrate their vaccine status through the NHS COVID Pass beginning on Friday, November 19.

The addition is meant to enable those who had their booster to travel to countries that have already introduced a time limit for the COVID-19 vaccine, including Israel. 

The NHS COVID Pass is the electronic record that travelers use to show they are vaccinated. It is approved in around 40 countries.

Britain said that the booster will not yet be added to the domestic COVID pass and that it would not yet be necessary to show evidence of a booster to enter the country.

Some 13 million boosters have been administered in the UK so far, the DHSC said.