The regulator recommends this booster shot from 6 months after the second injection
The more than 30 million Spaniards over 18 years of age who have already completed the schedule or who are still in it will be inoculated again over the next half year to receive the third dose of the covid vaccine, which in all cases will be from Pfizer, regardless of the prophylaxis they received the first time.
The European Medicines Agency has authorized this Monday the administration in the 27 of the “additional” intake (booster) to all adults of the formula of the German-American consortium. That – recognized today officials of the department headed by Carolina Darias – was the signal that Health was waiting to immediately launch the revaccination campaign this month of October.
The Committee for Human Medicines (CHMP) of the EMA, which since September 6 was immersed in an “accelerated evaluation” of the request of the North American giant, resolved in its meeting today that the data from Pfizer indeed “shows an increase in antibody levels when a booster dose is given approximately 6 months after the second dose in people aged 18 to 55 years. “On the basis of these data.” Therefore, the committee committee concluded “that booster doses can be considered at least 6 months after the second dose for persons 18 years of age or older.” In other words, the green way to universal revaccination of adults, regardless of their health status or whether they are groups more or less exposed to the virus.
With this decision, the EMA went even further than the regulators of the United States, United Kingdom or Israel, which had limited themselves to recommending the third puncture only in the oldest age groups and certain groups of workers.
In Spain, until now, this booster dose was reserved exclusively for people with solid organ transplants, hematopoietic stem cell transplant recipients, patients receiving anti-CD20 drugs or very high-risk immunosuppressive treatments and those residents in senior centers.
Today’s decision by the EMA is a near total victory for the consortium of Pfizer and BioNTech, which had actually requested authorization to revaccinate the entire population over 16 years of age. And is that the EMA, under pressure from the majority of European countries in favor of inoculating and third doses to the largest number of their inhabitants, has even rejected the opinion of the European Center for Disease Prevention and Control (ECDC), which considered that “a booster dose is not urgent” in the general population, at least for the moment and pending further scientific evidence on the benefits of universalizing the third puncture.
Since last July, the pharmaceutical giant has been presenting different studies – not yet peer-reviewed, as required by the scientific community – that would suggest that inoculating that booster dose would increase antibody levels five to ten times more. against the original strain of the coronavirus and the Beta variant, the South African one.
At the end of last July, the American pharmaceutical company presented another study, in this case on the impact of a third dose of its prophylaxis in the Indian strain, which pointed out that this booster dose could “potentially multiply the neutralization of the Delta variant by 100 »Compared to the current two-dose regimen 21 days apart. Pfizer, in its documents, stated that its clinical trials would prove that this new inoculation can “strongly boost” protection against the Indian lineage.
What’s more, the laboratory pointed out that a third dose produces levels of antibodies against the Delta mutation 5 times higher in people between 18 and 55 years old and more than 11 times in people between 65 and 85 years old, compared to the levels that are reached. after only two inoculations.
Pfizer managers since last spring have been insisting that all their studies suggest that the booster dose should be inoculated between 6 and 12 months after the second injection, which is when antibody levels begin to drop drastically.
Pfizer CEO Albert Bourla pointed out two months ago that the company’s own studies confirmed that the effectiveness of its vaccine with just two doses drops to 84% four to six months after administration. Bourla explained that the company’s data shows that the maximum effectiveness of his prophylaxis is 96.2%, but only during the two months after receiving the two inoculations. Then, the effectiveness of the prophylaxis drops an average of 6% every two months, according to the study by Pfizer itself in which 44,000 people from the US and other countries participated but, as with the research on the vaccine and Delta , has not yet been peer reviewed.