Booster Doses of J&J and Moderna Vaccines – FDA Agenda
The FDA released briefing documents Tuesday on coronavirus booster doses for the Moderna and Johnson & Johnson vaccines
With several Americans who receive Pfizer vaccination shots already getting ready for a booster dose, millions of other Americans who received the Johnson & Johnson and Moderna vaccine wait eagerly to know when their turn will come. Federal regulators started undertaking that question this week. The Food and Drug Administration (FDA) assembles its independent advisers for the initial stage in the procedure of deciding whether booster shots of both these vaccines should be distributed and, if so, which Americans should receive them and when.
Next on FDA’s agenda: Booster shots of Moderna, J&J vaccines
In this May 19, 2021, file photo, a licensed practical nurse draws a Moderna COVID-19 vaccine into a syringe at a mass vaccination clinic at Gillette Stadium in Foxborough, Mass. Starting Thursday, Oct. 14, 2021, the… pic.twitter.com/Qd1YlByRii
The concluding approval is not expected for almost another week. Then, after the recommendations of FDA advisers, the health agency itself will decide whether to approve booster doses. Next week, the Centers for Disease Control & Prevention (CDC) made a panel that will further specify who should receive them. Moreover, its decision is dependent on the approval of the CDC director.
The overall procedure aims to strengthen public confidence in the COVID-19 vaccines. However, it already led to conflicts among agencies and experts – and papers the drug agency released Tuesday suggest the decisions of this week will be equally difficult. In the same way, in an earlier vaccine dispute last month, the advisory panel of the CDC supported Pfizer booster shots at the 6-month point for older people, Americans with underlying health issues, and nursing home residents.
Will teachers and Health Care Workers will take booster shots?
Rochelle Walensky, the Director of CDC, overruled her advisers and planned booster shots should also offered to those Americans with high-risk jobs such as healthcare workers and teachers, the decision which adds tens of millions more Americans to the list. Some health officials have concerns that the back-and-forth deliberations are spoiling the public effort to persuade the unvaccinated people to get their initial shots. They fear that the debate of booster shots will lead people to wrongly distrust the effectiveness of the vaccines in the first place.
When the panel of FDA gathers to review the Johnson & Johnson and Moderna vaccines, experts will discuss whether an additional Moderna dose should contain just half the original shot and the best timing for a second dose (booster) of the single-shot J&J vaccine. Furthermore, the panel will also look into the effectiveness and safety of matching-and-mixing different vaccine brands and something regulators endorsed so far.
According to the CDC, approximately one hundred and three million Americans received full vaccination with the formula of Pfizer, sixty-nine million with Moderna vaccine formula, and fifteen million with the formula of Johnson & Johnson. Officials took up the query of Pfizer booster shots first because the health agency submitted its statistics before the other vaccine makers.
The meetings of the FDA come as United States vaccination hiked back more than one million daily on average, an escalation of over fifty percent during the last fifteen days. Pfizer booster shots and employer vaccine mandates mainly drove the rise in vaccination. Though the CDC and FDA so far endorsed Pfizer booster shots for specific groups only, Biden government officials, including Anthony Fauci, suggested that extra doses will ultimately recommend for most Americans.
What are the side effects of booster shots?
The first two doses of the Moderna vaccine contain a hundred micrograms of vaccine each. But the company says fifty micrograms should enough for a booster shot for healthy individuals. Moderna study of three hundred and forty-four people and gave them a fifty-microgram dose six months after their second vaccine shot, an antibody level increased. The drugmaker said the booster dose generated a forty-two-fold rise in antibodies targeting the more infectious delta variant.
Booster Doses of J&J and Moderna Vaccines are FDA Latest Agenda Source: Web
The company said that the side effects of booster shots were similar to the fevers and body pain that Moderna vaccine recipients usually experience after their second regular dose. On the other hand, for the people who received the Johnson & Johnson vaccine, the company submitted statistics to the Food and Drug Agency for different options: a booster dose at two months or six months. In its FDA submission, J&J said that a six-month booster dose suggested but that an additional shot could be given at two months depending on the situation.
In September, Johnson & Johnson released statistics that showed that a booster shot injected at two months provided ninety-four percent protection against moderate-to-severe coronavirus infection. J&J refused to share patient data on six-month booster shots, but early measures of antibodies suggest it provides even higher protection. Further, it added that even without a booster dose, its vaccine remains almost eighty percent effective at preventing coronavirus hospitalizations in the United States.
