US FDA Advisors Evaluate Approval of Moderna’s COVID Booster Jab

An advisory panel from the U.S. Food and Drug Administration (FDA) is expected to vote on whether to approve a third dose of Moderna Inc.’s COVID-19 vaccine, as the Biden administration intensifies efforts to vaccinate more Americans.

Moderna awaits approval Thursday of a booster that includes 50 micrograms of vaccine, half the regular dose but still higher than the Pfizer-BioNTech injection, which contains 30 micrograms.

Last month, the FDA approved booster doses of Pfizer-BioNTech for specific segments of the US population.

The FDA advisory panel will vote on whether Moderna boosters should be given six months after the second dose to people 65 years of age or older, those at high risk for severe COVID-19, and people 18 to 64 years of age who are frequently exposed to coronavirus infections due to their jobs.

President Joe Biden, who is lobbying American companies to adopt mandatory vaccine requirements, said Thursday that he hopes the FDA will soon approve more booster doses and vaccines for children as the coronavirus pandemic in the U.S. It seems to be decreasing.

“It’s working. We are making progress,” Biden said in remarks at the White House.

After seeing a spike in infections mid-year, the US is experiencing a decline in COVID-19 cases, hospitalizations, and deaths.

Over the past six weeks, daily COVID-19 cases were down 47 percent nationwide, while hospitalizations were down 38 percent, Biden said, citing data from the White House COVID-19 task force.

But US officials fear that as the American population flocks indoors in the colder months of winter, infection rates may rise again. “Now is not the time to give in. We have a lot more to do, ”Biden said.

There are 66 million American adults who have not yet been vaccinated, he added.

The US President has urged private companies to require workers to be vaccinated, and the US Department of Labor is preparing to issue an emergency rule requiring employers with more than 100 employees require vaccinations.

“Every day, we see more companies implementing vaccination requirements, and the accumulated data shows that they work,” Biden said.

A healthcare worker holds a vial of Moderna COVID-19 vaccine at a pop-up vaccination site in Manhattan in New York City on January 29, 2021 [File: Mike Segar/Reuters]

Republican opposition

However, Biden’s push to demand vaccines has met resistance, especially in Republican-led parts of the country.

In Texas, Governor Greg Abbott issued an order on October 11 to prohibit private companies from imposing vaccine mandates. White House officials have said that federal rules supersede such state orders.

“Vaccination requirements should not be another issue that divides us. That is why we continue to fight the misinformation that exists, ”Biden said.

If the FDA approves the Moderna booster, as expected, the US Centers for Disease Control and Prevention (CDC) will make specific recommendations on who should receive the vaccines. Biden said he also hopes Johnson & Johnson’s coronavirus vaccine for booster shots will be approved soon.

In a hearing Thursday before the FDA advisory panel’s expected vote, Israeli health officials said booster injections of the Pfizer-BioNTech vaccine had improved protection against severe COVID-19 cases in people in their 40s. or more in Israel.

“What we are seeing is a break in the curve of the epidemic in Israel,” said Dr. Sharon Alroy-Preis, director of public health services at the Israel Ministry of Health.

Alroy-Preis said that the Israeli booster vaccination program, which now includes 50 percent of the population across all age groups, is beginning to reduce infections even among unvaccinated populations in Israel.

The World Health Organization (WHO) has asked rich countries like the United States to delay offering booster vaccines until more people in less developed countries receive a first dose of the vaccine.

Meanwhile, United Nations Secretary General Antonio Guterres has asked for $ 8 billion to ensure that COVID-19 vaccines can be distributed fairly around the world.

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