Moderna announced on Wednesday that it had submitted the first information to the US Food and Drug Administration (FDA) for permission to administer a third, booster dose of its vaccine against COVID-19 in the USA.
"We are delighted to have started the application process," said Moderna President and CEO Stefan Bancel. "We are committed to continuing to take the lead against the virus."
The American biotechnology company delivered the results of its clinical trials to nearly 350 participants who received a booster dose of the COVID-19 vaccine six months after the second. The dosage of the third dose is 50 micrograms, ie half the amount of the two initial doses. According to Moderna, the level of antibodies that fight the virus had "significantly decreased" after "about six months" from the first two doses of the vaccine.
However, "after a third dose, a corresponding percentage of antibodies was achieved" at all ages. Moderna said it expects to submit this data to the European Medicines Agency (EMA) as well as to other regulators "in the coming days".
Pfizer / BioNTech submitted the first results of its clinical trials to the FDA in mid-August for approval of a third dose of its vaccine against covid-19. The FDA announced yesterday that an advisory committee will meet on September 17 "to discuss the issue of additional doses of vaccines against covid-19And specifically to consider Pfizer 's request. The establishment of this committee is a precondition for the granting of a permit. High-ranking health officials said in late August that the booster campaign for Moderna and Pfizer / BioNTech vaccines covid-19 will begin on September 20 for all Americans who received the second dose of the vaccine eight months ago.
However, experts have been critical of the decision, which was taken before health services could conduct an independent inquiry. In addition, available data currently show that vaccines against covid-19 remain effective in preventing serious illness, hospitalization and death, which is their main goal, according to them. Furthermore, the issue of a third booster dose raises the issue of inequalities in the distribution of vaccines against covid-19, at a time when many countries - mainly in Africa - have access to a limited number of doses. In the US, some immunosuppressed people may already be receiving a third dose of the vaccine covid-19.