The European Medicines Agency (EMA) today released the first comprehensive vaccine safety update COVID-19 - Comfnaty, of Pfizer and concludes that the safety data collected for the use of Comirnaty in vaccination campaigns is in accordance with the known vaccine safety profile, no new side effects have been identified and any deaths not related to it.
It also includes the EMA Safety Committee (PRAC) assessment of deaths reported after vaccination with Comirnaty, including deaths in frail, elderly people.
The PRAC analyzed the cases and took into account the presence of other medical conditions and the death rate for respective age groups in the general population.
The PRAC concluded that the data showed no association with vaccination with Comirnaty and that the cases did not raise safety concerns.
The safety and effectiveness of Comirnaty will continue to be monitored as it is used in all Member States and worldwide, through the EU pharmacovigilance system, additional company studies and independent studies coordinated by European authorities.
EMA is also expected to issue a conditional license (CMA) recommendation to the AstraZeneca vaccine today, if the relevant data are found to be positive. The head of the organization had stated on Tuesday that she does not rule out the establishment of a license only for certain groups of the population, such as those under 65 years of age.
In addition to the positive preliminary data on the Novavax vaccine in the UK, it is worth noting that on 17 December the Commission concluded exploratory talks for a pre-contract for the supply of 100 + 100 million doses.
Today, the Commission is expected to introduce a mechanism for transparency of vaccine exports from the EU, which will have a deterrent effect to prohibit third governments from pressuring companies to default on contracts with the EU. one step further, citing Article 122 TFEU on securing the supply of the internal market.
The president of the commission called a teleconference with the CEOs of all the vaccine manufacturers on Sunday with whom Brussels signed contracts, including Paul Hudson of Sanofi (which, however, is abandoning its own vaccine and will produce Pfizer). Moderna's Stéphane Bancel, Curevac's Franz-Werner Haas (the first EU-invested company), Uğur Şahin, AstraZeneca's Pascal Soriot and Albert Bourla of BioNTech / Pfizer. The President will be accompanied by the Commission's Chief Virologist Peter Piot.
Source: KYPE