The external expert consultant of the FDA of the US Food and Drug Administration unanimously gave the green light to Moderna Inc's COVID-19 vaccine booster injection. This means that the FDA may soon approve the booster injection of a second COVID-19 vaccine for some Americans.
On Thursday, Oct. 16, US Eastern time, all 19 advisers to the Advisory Committee on FDA Vaccines and related Biological products (VRBPAC) voted unanimously to recommend that FDA approve the emergency use authorization for the third dose of Moderna Inc vaccine. Moderna Inc applied for a booster dose of 50 micrograms, which is half of the dose of each of the first two injections.
If approved, Moderna Inc's strengthening needle will be limited to people aged 65 or above, people aged 18 to 64 who are at high risk of new coronary disease, and people aged 18 to 64 who are at high risk of severe or high risk of infection in the working environment. These people can receive enhanced injections at least six months after the first two injections.
In late September, the FDA approved Pfizer Inc's authorization for emergency use of the needle, and only people aged 65 and over, who are at high occupational risk and at high risk of severe illness, are allowed to receive the vaccine.
The progress fell short of the Biden administration's original goal of strengthening needle popularization programs. It had planned to provide enhanced injections to adult nationals who had completed vaccination for at least eight months from September 20. At a meeting on September 17th, FDA's VRBPAC advisers rejected Pfizer Inc's application for a nationwide booster injection by an overwhelming majority. Wall Street articles mentioned at the time that, including two FDA officials, earlier in the week on the 17th, a number of scientists known as the "all-Star" lineup by the media wrote in the Lancet that there was no need to strengthen needles for most vaccinators.
After Moderna Inc, FDA will also evaluate the enhanced injection of the COVID-19 vaccine developed by Johnson & Johnson. Recent studies have shown that compared with Johnson & Johnson's own booster injection after being vaccinated with Johnson & Johnson vaccine, Johnson & Johnson vaccine is more effective as a combination of booster injection and other vaccines, that is, mixed vaccination.
At the end of last month, Anthony Fauci, a senior infectious disease expert in the United States and director of the Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), said that NIH was nearing completion of the experiment of initial injection and enhanced injection of three kinds of vaccine, Pfizer Inc, Moderna Inc and Johnson & Johnson, and the mixed injection research data of Moderna Inc vaccine could be obtained. Johnson & Johnson vaccine mixed injection research data may be ready within a week, by mid-October. The study of mixed injection and enhanced injection of Pfizer Inc vaccine may be completed.