The advisory panel of the Food and Drug Administration unanimously recommended that Thursday’s booster shots be given. ModernaThe Covid-19 vaccine is now available to those 65 years and over and to other vulnerable Americans. This crucial step will allow the U.S. to start giving third shots to the approximately 69 million who have already received the vaccine.
Moderna would be in compliance with the third shot of guidelines if it was made by FDA’s Vaccines and Related Biological Products Advisory Committee. Pfizer and BioNTech’s vaccine. Those shots were authorized less than a month ago to a wide array of Americans, including the elderly, adults with underlying medical conditions those who work or live in high-risk settings like health and grocery workers.
The agency may not have always followed its advisory committee’s advice, but it does so often. The FDA could make a final decision about Moderna boosters within days. Next week, a CDC advisory committee will vote on the FDA proposal. It could recommend approval. If approved, the CDC will endorse it. Boosters shots may be available immediately to eligible Americans who received their vaccines no later than six months ago.
Booster shots have been a contentious topic for scientists — in and outside the government — especially as many people in the U.S. and other parts of the world have yet to receive even one dose of a vaccine. Some scientists disagree with the World Health Organization’s call for wealthy countries not to distribute boosters.
Biden’s administration believes that giving additional doses to the U.S. populace will provide long-term, durable protection against serious disease, hospitalization, and death due to the rapid-moving delta variant.
Before the vote Dr. Peter Marks (FDA’s highest vaccine regulator) addressed the committee. He said that FDA welcomes different views on the complex and ever-changing data.
“I would like to ask you to do your best to concentrate our discussion on the science of the application being considered today and not on operational matters related to a booster program on global issues related vaccine equity,” he said.
Moderna submitted a Sept. 1 FDA application for authorization to a booster dosage. The results were determined based upon a study of about 170 adults. These are far fewer people than those who received Pfizer’s booster. Moderna said a third shot at half the dosage – 50 micrograms – used for the first two jabs was safe and produced a strong immune response.
The company will send out a letter explaining to providers the different dosage of the third shot once it has been approved, according to Dr. Jacqueline Miller (head of infectious disease research at the company).
The FDA released a Tuesday document from Moderna stating that side effects caused by Moderna’s boosters were similar to those after the second dose. Moderna did not report any cases of myocarditis and pericarditis in the trial participants, even though they were present for up to 29 days.
The panel heard multiple presentations before recommending third shots. One of these was from Isreal’s health officials, who began providing boosters for its citizens earlier than many countries. Although the country has used mostly Pfizer vaccine, some Moderna boosters were given.
Since its launch in July, the country has given out 3.7 million extra shots. Nearly a third of those shots went to seniors, Sharon Alroy Preis, Director of Public Health Services at Israel’s Ministry of Health told the panel.
The data showed that people who were given a booster dose of Covid were more likely to become infected or get severely ill. Officials have identified 17 cases in the past of myocarditis and pericarditis after third-dose treatment.
She stated that Israel’s administration of booster doses has helped to reduce the number of severe infections.
This is an ongoing story. Stay tuned for new updates.