Netherlands: Pfizer and Moderna COVID booster shots approved by EMA for over-18s

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The Head of Biological Health Threats and Vaccines Strategy at the European Medicines Agency (EMA), Marco Cavaleri, discussed a recent decision to approve Cominarty (Pfizer/BioNTech) and Spikevax (Moderna) COVID-19 booster shots during a briefing in Amsterdam on Tuesday.

“The Committee (Committee for Medicinal Products for Human Use) concluded that administering a booster dose to people aged 18 years and older at least six months after the second dose is safe and provides a sharp increase in the amount of antibodies to a much higher level than what was seen just after a second dose,” explained Cavaleri.

The EMA officially updated their recommendations on extra doses and boosters on Monday.

SOT, Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy at European Medicines Agency: “The CHMP (Committee for Medicinal Products for Human Use) concluded that third doses of Comirnaty (BioNTech-Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems aged 12 years or older at least 20 days after their second dose. The recommendation for both vaccines is based on studies in patients with severely weakened immune systems because of the use of immunosuppressive drugs after an organ transplant.”

“Although there is no direct evidence yet from studies measuring effectiveness, it is expected that a third dose would increase protection at least in some of these patients and the EMA (European Medicines Agency) will continue monitoring emerging data that would estimate the effectiveness of the third dose in this population.”

“It is important to distinguish between third doses for people with severely weakened immune system and booster doses for the general population. For the latter, the CHMP has evaluated an application for Comirnaty to add a booster dose to the product information, the application is based on data after a booster dose was given approximately 6 months after a second dose in individuals aged 18 to 25 years of age.”

“The Committee concluded that administering a booster dose to people aged 18 years and older at least six months after the second dose is safe and provides a sharp increase in the amount of antibodies to a much higher level than what was seen just after a second dose.”

“However, let me say that no firm recommendations can be made at this stage, including when and for whom to implement a booster dose. Such decisions should be made based on the available epidemiological and vaccine effectiveness data, taking also into account the limited data on safety that we have for the booster.”

“It is important to stress that most of the cases of myocarditis reported are mild and self-limiting. It has to be acknowledgeable though that the risk of myocarditis and pericarditis after a third dose has not been characterised so far because it is a very rare event, however, overall the safety profiles seen after the booster dose is reassuring.”

“[The] EMA is currently evaluating an application for the use of a booster dose also for Spikevax to be given at least 6 months after the second dose in people aged 12 years and older. The CHMP will carry out an accelerated assessment of all the data submitted by the company, including results from an ongoing clinical trial. Based on these reviews the CHMP will recommend whether updates to the product information are appropriate and the EMA, as usual, will communicate the outcome of the assessment in due course.”

“We are aware that some [European] Member States have already started administering booster doses. As a reminder, implementation of vaccination campaigns in the European Union remains a prerogative of the public health authorities guiding the vaccination campaign in each member state. Implementation of vaccination strategy at national or subnational level taking into account the local conditions including the epidemiological status, the effectiveness of the vaccination campaigns and any operational aspects related to the capacity of the national health systems.”

“In the product information we will be specifying that this is a prudent recommendation and moreover, it will be important to look carefully at the effects in this data that are emerging from the different European Member States when deciding whether it will be good to use that booster at that point in time. So I think the conclusion on the data are pretty similar but the implementation in terms of regulatory decision are slightly different because we are working in a much more complex environment in Europe.”

#Vaccines #COVID19 #Pfizer #Moderna

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