The double decision issued yesterday by the European Medicine Agency (EMA) favorable to the use of a third dose of Vaccines based on MRNA -comirnaty (Biontech and Pfizer) and Spikevax (modern) in immunosuppressed people, and to the administration of a third dose of reinforcement for people with a normal immune system, at the moment only with the Pfizer and Biontech vaccine, it has focused a large part of the explanations that Marco Cavaleri has issued today, responsible for Biological Products and EMA vaccine strategy, in biweekly comprehension It has been doing to inform about the progress of the European Agency in the evaluation of vaccines and treatments against the virus.
"It is important to distinguish between the administration of a third dose to people with a severe immunosuppression and the reinforcement dose for the general population, for which the EMA Advisory Committee - the ChMP - has evaluated the request made by Pfizer and Biontech to add this dose of reinforcement of comirnatyen the information of the product ".
Caveleri has pointed out that emerging data from other parts of the world, including those of Israel, the United Kingdom and the United States "point to an erosion in protection against mild disease, and in some studies even compared to the most serious ways" . These data would justify the convenience of administering that third dose of reinforcement in the general population - after 18 years and past six months since the administration of the complete pattern, as the recommendation of the EMA has been issued, although this Decision corresponds to national or regional authorities, so "will be the ones that should be assessed based on the data available on epidemiology and effectiveness of vaccination campaigns, also taking into account the limited data we have at this time on The reinforcement dose ".
The agency spokesman has added that "the data collected by EU Member States will be important to define the best vaccination strategies; We know that some States have already begun to administer reinforcement doses, given that strategies in campaigns of Vaccination is a prerogative of the authorities of each country according to local conditions such as the pandemic state, the effectiveness of vaccination campaigns or the capacity of national or regional systems ".
Specifically, the request to expand Comirnatyse indications has based on the administration data of the aforementioned reinforcement dose six months after the second dose in people between 18 and 65 years. The Committee has concluded that the administration of this dose in the aforementioned conditions "is safe and provides an important increase in the production of antibodies at levels much higher than those observed after the second dose, so this option should be considered in the context of vaccination campaigns. "
In addition, EMA is currently evaluating an application for the use of a reinforcement dose of SpikeVAX for its administration at least six months after the second dose and more than 12 years. "The CHMP will make an accelerated evaluation of all the data offered by the company, including the results of a start-up trial."
"From what we know so far-added Cavalemi- When two doses are administered, vaccines offer good protection against severe complications by Covid, such as hospitalization and deaths, and this is something that we monitor very closely to update the data and protocols to recommend ".
Regarding the recommendation to administer the third dose of vaccines based on Arnmen immunosuppressed people, especially since having received immunosuppressive treatment after a transplant, the EMA vaccine strategy manager recalled that the trials with COMINARTY have shown that a high percentage Of these patients "had not been able to generate enough antibodies against SARS-COV-2 after the second dose, but they could do it after a third dose. In a similar way, the study with Spikevax showed that transplanted patients who have received a third Dosage of this vaccine had higher levels of antibodies than those who had received only two doses ".
"Based on the limited amount of data available, the use of the third dose is restricted to patients with severe immunosuppression, since there is still no direct evidence that patients with lower levels of immunosuppression would benefit from receiving a third dose as part as part Of his vaccination pattern, "he has punctualized.
Although there is still enough evidence of increased protection with these third doses, "it is expected to increase protection at least in some of these patients," although EMA will continue to study the data that arrives on third doses in this group of population.
The agency also continues to evaluate the cases of myocarditis and pericarditis associated with the use of mRNA-based vaccines, "especially after the second dose, it is important to emphasize that the reported cases are mild, although it is necessary to recognize that the risk of myocarditis and pericarditis after the Administration of a third dose has not yet been characterized because it is a very rare effect. In any case, the general safety profile observed after the third dose is reassuring. "
Finally, Cavaleri has remembered that treatments against Covid-19 are still evaluated, and the objective of approving approvals by the end of this year. The EMA has begun to evaluate an application for the rekirone monoclonal antibody -regdanvimab-, from the CELLTRION South Korean pharmaceutical, in adults with COVID-19 that do not need oxygen therapy and are at risk of progression towards the serious form of the disease. The Agency will study the product in accelerated deadlines and could issue an opinion within a period of two months depending on the strength of the data and that additional information may be required for the evaluation. "Meanwhile we continue working on the continued evaluation procedure -rolling Review- in three other monoclonal antibodies and three immunomodulators, and their reviews progress well; Committee's opinions for some of them could occur in the coming weeks."Date Of Update: 09 October 2021, 03:47