The European Medicines Agency (EMA) is preparing to approve Pfizer / BioNTech’s anti-Covid vaccine adapted to combat Omicron’s Ba.4 and Ba.5 variants in the autumn. The two pharmaceutical companies have started a clinical trial and are expected to submit an application for authorization to the European regulatory body soon, which could then proceed with rapid approval in the autumn. A signal in addition to the others that the wait for vaccines adapted to the latest variants of Covid is about to end.
In the EU 350 thousand infections a day
At the beginning of August, infections in the Old Continent remain stable – on average, around 350 thousand a day – but the European Commission works tirelessly to be ready for the cold season, when the curve is expected to raise its head. And it does so first by moving forward a few weeks the deliveries scheduled for the summer with Moderna, to ensure that countries have the doses they need when they need it most, and then by starting to book the first doses of vaccines adapted to the variants. Ba.4 and Ba.5 from Omicron. First, however, the authorization of the European Medicines Agency (Ema) will be needed, whose lens has been, since mid-June, aimed at updating immunizers destined to target both the original SARS-CoV-2 strain and subsequent ones. subtypes.
The agreement between Brussels and Moderna
In the aftermath of Pfizer and BioNTech’s announcement of their first clinical trial of the updated vaccine to neutralize the new variant duo, Brussels closed an agreement with US Moderna to once again adjust its delivery schedule, postponing to September and during the autumn-winter the supply of the lots initially planned for the summer. An agreement that will ensure that “countries have access to the doses they need at the right time to protect their citizens,” explained the European Commissioner for Health, Stella Kyriakides. And, above all, which ensures the first 15 million doses adapted to the variants to the European capitals. Subject, as usual, to the marketing authorization by Ema.
Family doctors: very much the submerged
The premises reinforce the hope of facing the cold season with new weapons in fighting a pandemic still far from being over. «On the Covid front we are experiencing a strange summer, with a lot of submerged. We observe many cases, confirming the fact that not only has the virus not disappeared, but it is strongly underestimated », underlines Claudio Cricelli, president of the Italian Society of General Medicine and Primary Care (Simg). Numbers that will inevitably rise again with the arrival of autumn. For this, Kyriakides noted, “Member States must have the necessary tools”.
Maximum safety, Ema’s firm line
BioNTech and Pfizer recently announced the launch of a clinical trial for the updated vaccine, aiming for “a broad and prolonged protection”. And Moderna itself, with the agreement reached with Brussels, expects to be ready by September. When more than a million doses of the vaccine developed by Valneva are also on the way. Ema, on the other hand, has the delicate task of keeping up with the new variants while ensuring maximum safety. “Promises are not enough for me,” said the director of the EU agency, Emer Cooke, a few days ago.