Wednesday's booster shots were approved by the Food and Drug Administration for Moderna's and Johnson & Johnson's Covid-19 vaccines.
FDA stated that booster doses of Moderna COVID-19 vaccine were authorized for patients 65 years and older, as well as those at high risk of serious disease.
The FDA approved a booster dose of the J&J vaccine for those who have received it.
Moderna 3 for at-risk adults
After an advisory panel unanimously recommended the Moderna booster shot October 14, the FDA's decision was made. Data show that the booster shot can increase the immune system and have similar side effects to the other doses.
Moderna CEO Stphane Bangle stated that they are committed to keeping ahead of the virus, and following the evolving epidemiology for SARS-CoV-2.
"We look forward making our booster available for people in the US to help them protect themselves from this ongoing public health emergency."
The booster shot should be administered at least six months following the last dose. It will have half the strength of the two Moderna vaccines.
Moderna is still evaluating the third booster dose and has only presented limited data to FDA.
This data contains a small number of 149 volunteers who received the booster shot in phase 2. They were tested for antibodies and then compared with the levels after the second dose.
Research showed that antibody levels after the booster shot were the same as those following the second dose. However, not all patients experienced a 4-fold increase in antibodies. This is one FDA-recommended criteria.
Dr. Patrick Moore, a member of the FDA committee, stated that "the data itself isn't strong." Moore, a professor of microbiology at the University of Pittsburgh said that he voted in favor of the vaccine based on his "gut feeling".
The booster shots are just as safe as the first two doses, and most people experience mild to moderate side effects. Even though the booster dose of the vaccine is only half that of the first two doses, this is still true. The original doses of 100 micrograms each were used, and the booster shot contains 50 micrograms.
Side effects of booster shots include headaches, fatigue, muscle pain, pain at the injection site and pain from the muscle.
Everyone gets a second J&J shot
For everyone who has received the vaccine, the FDA approved a second dose.
The J&J vaccine is a single-dose shot, unlike the mRNA-based shots which are administered in two doses. The FDA recommended that every person who received a J&J vaccine in the US, including those with severe diseases, be eligible for a booster shot.
Two months after receiving their first J&J vaccination, people can receive a booster shot.
J&J submitted data from a study with just 17 volunteers, who received a second dose six months later. Although the data seemed to be in line with FDA guidelines for boosters, the FDA reviewed it and found that the results were not as expected.
J&J also has data on a larger trial with 16,000 volunteers, who received a booster shot within two months. Although this data isn't independently verified by FDA scientists it shows more evidence for the benefits of booster shots.
"We now have evidence that a booster shot further enhances protection against COVID-19, and is expected to prolong the duration of protection significantly," Dr. Paul Stoffels (J&J's chief scientist officer), stated in a September news release.
FDA endorses mix and match booster shots
For Americans who need booster shots, the FDA has approved a mix-and-match approach. This allows them to get a different COVID-19 vaccine booster than they originally received. These booster shots are sometimes called "heterologous".
A new study has shown that an mRNA booster shot following the J&J shot may result in a stronger immune response than a second J&J booster.
The "mix-and match" trial included 458 people who were vaccinated with Moderna, Pfizer, or J&J vaccines. They were then given a boost from one of these three brands. J&J recipients experienced a significant increase in their virus-fighting antibodies after receiving a Moderna/Pfizer booster than they did with a second J&J shot.
"What the study shows, regardless of what an individual has received previously, getting boosted using one of the three vaccines we evaluated, the one form Moderna, [J&J], or the one at Pfizer led to good antibody reactions in each of these groups," Dr. Robert Atmar, Baylor College of Medicine, told Insider.
Business Insider originally published this article.
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