US FDA advisers mull approval of Moderna’s COVID booster jab

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With 66 million American adults still unvaccinated, President Biden is pushing for emergency approvals of booster jabs.

A US Food and Drug Administration (FDA) advisory panel is expected to vote on whether to approve a third dose of Moderna Inc’s COVID-19 vaccine, as the Biden administration ramps up efforts to get more Americans vaccinated.

Moderna is hoping for approval on Thursday of a booster jab that includes 50 micrograms of vaccine, half the strength of its regular dose but still higher than the Pfizer-BioNTech shot, which contains 30 micrograms.

The FDA last month approved Pfizer-BioNTech booster jabs 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 individuals aged 65 and older, those at high risk of severe COVID-19 and to people ages 18 to 64 who are frequently exposed to coronavirus infections due to their jobs.

President Joe Biden, who is pushing US companies to adopt mandatory vaccine requirements, said on Thursday that he expects the FDA will soon approve more booster jabs and vaccines for children as the coronavirus pandemic in the US appears to be easing.

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

After seeing a surge in infections in the middle of the year, the US is now experiencing a decline in COVID-19 cases, hospitalisations and deaths.

During the past six weeks, daily cases of COVID-19 are down 47 percent nationwide, while hospitalisations are down 38 percent, Biden said, citing White House COVID-19 task force data.

But US officials fear that as the North American population congregates indoors in the coming colder winter months, infection rates could surge again. “Now is not the time to let up. 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 get vaccinated, and the US Labor Department is preparing to issue an emergency rule requiring employers with more than 100 employees to require inoculations.

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

A healthcare worker holds a vial of the 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

Biden’s drive to require vaccines has faced resistance, however, especially in Republican-led parts of the country.

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

“Vaccination requirements should not be another issue that divides us. That’s why we continue to battle the misinformation that’s out there,” Biden said.

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

In a hearing on Thursday in advance of the FDA advisory panel’s expected vote, Israeli health officials said booster jabs of the Pfizer-BioNTech vaccine had improved protection against severe cases of COVID-19 in people aged 40 and older in Israel.

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

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

The World Health Organization (WHO) has called on wealthy countries like the US to hold off on offering booster shots until more people in less-developed countries receive a first dose of vaccine.

Meanwhile, United Nations Secretary-General Antonio Guterres has called for $8bn to ensure that COVID-19 vaccinations can be fairly distributed across the world.



Al Jazeera and news agencies

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