The EMA is “ready” for the adaptation of vaccines “if necessary” | International


The executive director of the European Medicines Agency (EMA), Emer Cooke, stressed on Tuesday the concern about the new omicron variant, but noted that “we already knew that viruses mutate and we are prepared” to adapt COVID-19 vaccines “if necessary”. “We still do not know if it is,” he said in an appearance before a European Parliament committee in Brussels, in which he recalled that since February 2020 there is “a guide to allow companies to accelerate the adaptation of vaccines if it were necessary”. “And we must be very careful at this point in saying this: we do not know yet if this is going to be necessary, but if it were, we already have a contingency plan,” he added.

If in the end it is shown that it is necessary to adapt the vaccines, the EMA could take “about three or four months” to give its approval to a new version of the preparation, but that will only happen “when the data are available” and that, has assured, “it does not depend on the EMA, but on several factors, such as the epidemiological situation, the effectiveness of the current vaccine and the circulation of this variant in Europe.”

“We are prepared for the worst”

Cooke has indicated that the EMA is in contact with international drug agencies, the World Health Organization (WHO), the European Center for Disease Prevention and Control (ECDC) and pharmaceutical companies “to ensure that we are prepared for the worst. , although we hope the best happens. ” Thus, he has reaffirmed the need to expand vaccination coverage in “those countries where it is dangerously low” and has considered this “particularly important as we learn more about the omicron variant.”

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Cooke explained that health authorities already feared that “at some point” a mutation of the virus “means that current vaccines have to be adapted”, but he recalled that until now all available preparations are still effective against all variants that they circulate “in Europe.” We don’t know if that will continue to be the case with the omicron variant but we have to make sure we understand it. For that, part of the work is to analyze the cross-neutralization of the vaccines, a laboratory process that takes about two weeks to see if the vaccines offer protection against the new variant, “he explained.

Ensures that the vaccines we have continue to protect

In any case, he has opined that the situation in Europe is different from that of South Africa because European vaccination coverage is more advanced “and we are already in the phase of recommending booster doses”, so there are “several factors that could influence “in the circulation of the omicron variant in the European region. “From the available data, we continue to see that licensed vaccines remain effective and continue to save people from severe COVID-19 and death. Even if the new variant continues to spread, the vaccines we have will continue to offer protection,” he reassured. .

Advocates for booster shots and vaccinating children

However, Cooke has recognized that the effectiveness of vaccines decreases with the passage of time and considers it “very important” to start the vaccination with the booster dose for people who receive this recommendation, as well as the vaccination of children, after last week’s approval of Pfizer’s use in minors between the ages of 5 and 11.

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In addition, the EMA hopes to have “by the end of this week” a scientific recommendation on the strategy of “mix & match”, the combination of different vaccines. Cooke has emphasized that “we have many more tools to fight this pandemic right now than we had last winter”, but warns that vaccines “are and will continue to be the key” to this.


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George Holan

George Holan is chief editor at Plainsmen Post and has articles published in many notable publications in the last decade.

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