Anjali Sundararaman, a student nurse at San Francisco State University, gave Xu Cuixia a dose of Moderna COVID-19 vaccine at the Vaccination Clinic of the Southeast Health Center in the Bayview-Hunters Point community in San Francisco, California on Monday, February 12. August 2021.
Lin Chiling | San Francisco Chronicle | Hearst Newspaper via Getty Images
When an important FDA advisory group meets on Thursday and Friday to discuss additional doses of Moderna and Johnson & Johnson vaccines, millions of Americans will get closer to receiving the Covid-19 booster this week.
Less than one month after the U.S. regulatory agency authorized Pfizer and BioNTech vaccine’s Covid booster injections to a wide range of Americans, including the elderly, adults with underlying diseases, and people working or living in the U.S., FDA’s vaccines and related biological products The advisory committee meeting was held. High-risk environments such as sanitation and grocery workers.
According to the latest data provided by the CDC, as of Saturday, more than 7 million Americans have received booster doses in the United States.
The independent committee members of the FDA and the Centers for Disease Control and Prevention said at the time that they were frustrated that only Pfizer recipients were eligible for additional vaccines, leaving out the millions of Americans who received Moderna or Johnson & Johnson vaccines.
The FDA advisory group is scheduled to discuss data on the safety and effectiveness of Moderna’s enhanced injections in adults on Thursday. On Friday, the committee is expected to debate the Johnson & Johnson injection for adults. The FDA can make a final decision within a few days after the meeting and hand it over to the CDC and its vaccine advisory committee to make its own decision.
The CDC’s next vaccine consultation meeting is scheduled to be held from October 20th to October 21st, and boosters are expected to be discussed at the meeting.
The FDA meeting was held last week after the average daily number of new coronavirus cases in the United States fell below 100,000, more than 56% of the population was fully immune to the virus and the pandemic showed signs of remission. Health experts say that vaccinations, receiving booster shots and avoiding large gatherings are key ways to alleviate the surge in cases that may occur during the holidays.
The Biden administration hopes that as the fast-moving delta variant spreads, increasing the US population will also continue to ensure long-term and lasting protection against serious illness, hospitalization, and death.
This pressure has led to a surge in the number of hospitalizations in the United States, mainly those who have not been vaccinated. Nonetheless, according to data compiled by the CDC, as of September 20, some vaccinated Americans had suffered so-called breakthrough infections, of which only more than 19,000 (less than 1%) were hospitalized or died due to the new coronavirus.
Norman Baylor, former director of the FDA’s Office of Vaccines, said: “Even with delta, the current vaccines perform pretty well in hospitalizations and serious illnesses.” “Infection seems to be a problem.”
Last month, Moderna stated that half of the dose used in the first two injections for the third injection is safe and produces a stronger immune response than the second injection in its Phase III clinical trial.
Johnson & Johnson (J&J) said last month that two months after the first dose of the vaccine in the United States, the second single dose of the vaccine is safe and can increase the protection rate of symptomatic infections from about 70% to 94%.
Baylor said in a telephone interview that the FDA can authorize Moderna and J&J to intensify injections under the same standards as Pfizer, or change the direction and expand the number of Americans eligible for additional injections.
“The question is: does everyone need boosters now?” said Baylor, the current president of the Biological Products Consulting Group.
Baylor said committee members will have to debate whether the second dose is safe and effective for J&J recipients. He added that he does not expect Moderna’s third dose of vaccine to have any problems because it uses mRNA technology, which is also used to develop Pfizer’s vaccine.
“If I held my old position at the FDA, I might not bring Moderna to the advisory board because it is in the same category as Pfizer,” he said.
Dr. Isaac Bogoch, an infectious disease expert at the University of Toronto, said that in terms of public perception, the government’s communications regarding Pfizer’s enhanced injections have been confusing and “very destructive”.
“From the outside, it seems to be free for everyone,” Bogoch said. “Like, yes, there are some loose guidelines in the United States. But basically it seems that anyone can enter any pharmacy and get a booster shot, and then say you know what I smoke, I am obese, or I am a Health care workers.”