Green light from the European drug agency Ema for the third dose of the anti-Covid vaccine. The EU regulatory body’s Committee for Medicinal Products for Human Use (CHMP) concluded that “an extra dose of the Comirnaty * (BioNTech / Pfizer) and Spikevax * (Moderna) vaccines can be given to people with severely weakened immune systems, at least 28 days after the second dose “. In this case it is an ‘additional’ dose to be understood as completion of the primary vaccination cycle. As for the dose ‘booster’, intended as a booster for people with a normal immune system, with the aim of enhancing the response against Sars-CoV-2, the CHMP has evaluated for now the Comirnaty data and concluded that “the booster dose can be considered after at least 6 months from the second dose, for people aged 18 and over “. Evaluation still in progress, however, for the recall with Spikevax.
As for the immunosuppressed, the EMA explains in a note, “the recommendation comes after studies have shown that an extra dose” of Pfizer and Moderna mRna vaccines “increased the ability to produce antibodies to the virus that causes Covid-19 in organ transplant patients with weakened immune systems. Although there is no direct evidence that the ability to produce antibodies in these patients protects against Covid, it is expected that an extra dose can increase the ‘shield effect’ in at least some of them. ” The EMA will continue to monitor all data that emerge on the effectiveness of the additional dose, the agency assures, specifying that the product information of both vaccines will be updated to include this recommendation.
As for the general population, “the CHMP – continues the regulatory body – examined the data from Comirnaty that show an increase in antibody levels when a booster dose is administered about 6 months after the second dose, in people aged between 18 and 55 years “. And on the basis of this evidence, the panel concluded that the third dose can be considered for those over 18.
“At the national level – the EMA reiterates – public health bodies can issue official recommendations on the administration of booster doses, taking into account the emerging efficacy data and limited safety data”. The agency reiterates that “the implementation of” anti-Covid “vaccination campaigns in the EU remains the prerogative of the national technical advisory groups on immunization (Nitag) that guide the immunization plans in each EU member state. they are “in fact” best placed to take into account local conditions, including the spread of the virus (particularly any variant of concern), vaccine availability and the capabilities of national health systems. The EMA will continue to work closely together with national authorities and the European Center for Disease Prevention and Control (Ecdc) to evaluate the available data and provide recommendations aimed at protecting the population during the ongoing pandemic “.
RARE RISKS UNKNOWN THIRD DOSE, CLOSE MONITORING – “The risk of inflammatory cardiac conditions or other very rare side effects after a booster” of the anti-Covid vaccine “is not known and is carefully monitored”, states the European Medicines Agency Ema.
“As for all medicines – the EU regulatory body specifies in the note – the EMA will continue to examine all the data on the safety and efficacy of the vaccine. More information on the recall recommendations for Comirnaty *” by Pfizer and BioNTech “will be available in the updated product information “.