Moderna announced on Wednesday that it had submitted first data to the United States Medicines Agency for the purpose of obtaining approval for a booster dose in the United States.
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“We are happy to initiate the application process”, said in a statement Stéphane Bancel, CEO of Moderna. “We are committed to staying one step ahead of the virus.”
The American biotechnology company provided the results of trials conducted on nearly 350 participants, who received this booster dose six months after their second injection.
The dosage for this booster is 50 micrograms, or half the dosage of the initial injections.
According to Moderna, the levels of antibodies to fight the virus had “weakened significantly” after “approximately six months” after the first series of two injections.
But “after a third dose, a similar level of antibodies was reached”, and this for all age groups.
The booster dose was tolerated similarly to the first two.
Moderna said it plans to submit this data to the European Medicines Agency (EMA) and other regulatory authorities around the world “in the days to come”.
The Pfizer / BioNTech alliance also filed its first results with the US Medicines Agency (FDA) in mid-August to support its own request for authorization of a third dose.
The FDA said on Wednesday that an advisory committee would meet on September 17 “to discuss the subject of additional doses of COVID-19 vaccines,” and specifically to study Pfizer’s request for 16-year-olds.
The opinion of this committee is required before a possible authorization.
Senior health officials announced at the end of August that a recall campaign for COVID vaccines from Pfizer and Moderna would be launched from September 20, for all Americans who received their second dose eight months previously. The schedule is therefore tight to meet this date.
Experts have been critical of the decision, announced before scientific agencies conducted their independent analysis.
In addition, the available data shows for the moment that vaccines remain very effective against severe cases of illness, hospitalizations and deaths, which remains their main goal according to them.
The subject of the third dose has also revived the issue of vaccine inequalities, when many countries have only had access to a very limited number of doses, especially in Africa.
Some people who are immunocompromised may already receive a third dose in the United States.
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