The European Medicines Agency (EMA) has started an accelerated review of whether to recommend a third dose of Pfizer / BioNTech Covid-19 in humans approximately six months after the second dose.
A statement issued by the ESA on Monday said it was considering whether a third dose would be needed to “re-establish protection” for people aged 16 and over about six months after the vaccination process was completed.
EZA has indicated that it intends to take a decision in the next few weeks.
The Agency’s experts are evaluating data provided by Pfizer and BioNTech, including the results of an active study of around 300 healthy adults who received a third dose about six months after the second dose.
Pfizer has already asked the US Food and Drug Administration (FDA) to approve the third dose, and the US government said last month that additional doses are likely to be available by the end of September.
Israel, meanwhile, is already offering a third dose of Pfizer / BioNTech vaccine to fully vaccinated people, and similar plans are being considered in the UK, France and Germany.
In order to ensure a more equitable distribution of vaccines between rich and poor countries, the World Health Organization (WHO) called in August for a moratorium on additional doses of Covid-19 vaccines for people who have already been fully vaccinated against Covid-19, at least until the end of September.
EZA also said it was evaluating the need for a third dose of Pfizer / BioNTech Covid-19 vaccine and a third dose of Moderna Covid-19 vaccine for people with weak immune systems. The agency indicated that these people may need an extra dose.
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