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Vaccination Who will receive the third dose, when and with which coronavirus vaccine
Covid-19 The elderly of the residences, people on hemodialysis and those over 40 with Down syndrome will receive a 'third dose' against Covid
The double decision issued yesterday by the European Medicines Agency (EMA) in favor of the use of a third dose of mRNA-based vaccines -
Comirnaty
(BioNTech and Pfizer) and Spikevax
(Modern)
in immunosuppressed people, and the administration of a third
booster dose
for people with a
normal immune system
, for the moment only with the
Pfizer and BioNTech vaccine
, has focused much of the explanations that Marco Cavaleri, responsible for of Biological Products and Vaccine Strategy of the EMA, in the fortnightly appearance that it has been doing to report on 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 severe immunosuppression and the booster dose for the general population
, for which the EMA advisory committee - the CHMP - has evaluated the request made by Pfizer and BionTech adding this booster dose of Comirnaty
in the product information ".
Caveleri noted that emerging data from other parts of the world, including Israel, the United Kingdom and the United States, "point to an
erosion in protection against mild disease
, and in some studies
even against the most severe forms.
" . These data would justify the convenience of administering this third booster dose in the general population - from 18 years of age and six months after the administration of the complete regimen, as the EMA recommendation has been issued - although
this decision corresponds to national or regional authorities
Therefore, "it will be these that should assess it based on the available data on epidemiology and efficacy of vaccination campaigns, also taking into account the limited data that we have at this time on the booster dose."
The agency's spokesperson added that "the data collected by the EU member states will be important to define the best vaccination strategies; we know that
some states have already begun to administer booster doses
, given that the strategies in Vaccination is a prerogative of the authorities of each country according to local conditions such as the pandemic status, the effectiveness of vaccination campaigns or the capacity of national or regional systems ".
Specifically, the request to expand the indications of Comirnaty
has been based on the data of administration of the aforementioned booster 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 a significant increase in the production of antibodies to levels much higher than those observed after the second dose
, so this option should be considered in the context of vaccination campaigns ".
In addition, the EMA is currently evaluating an application for the use of a booster dose also of Spikevax
for administration at least six months after the second dose and in people over 12 years of age.
"The CHMP will do an expedited assessment of all the data provided by the company, including the results of an ongoing trial."
"From what we know so far," Cavaler added, "when two doses are administered, the vaccines offer good protection against serious complications from Covid, such as hospitalization and deaths, and this is something we monitor very closely to update the data. and protocols to recommend ".
Regarding the recommendation to administer the third dose of mRNA-based vaccines
in immunosuppressed people, especially due to having received immunosuppressive treatment after transplantation, the EMA's head of vaccine strategy 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 so after a third dose. Similarly, the study with Spikevax showed that transplant patients who received a third dose 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
, as there is no direct evidence yet that patients with lower levels of immunosuppression would benefit from receiving a third dose as part of their vaccination schedule ", he pointed out.
Although there is still insufficient evidence of increased protection with these third doses, "it is expected that these increase protection in at least some of these patients", although
the EMA will continue to study the data that arrive on the third doses in this group of
patients.
population
.
The agency also continues to evaluate 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 must be recognized that
the risk of myocarditis and pericarditis after 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 recalled that treatments against Covid-19 are still being evaluated, and the objective that approvals can be produced by the end of this year. The EMA has begun to evaluate an application for the
monoclonal antibody Rekirona
-regdanvimab-, from the South Korean pharmaceutical company Celltrion, in adults with Covid-19 who do not need oxygen therapy and are at risk of progression to the severe form of the disease. The agency will study the product in an accelerated timeframe and
could issue an opinion within two months
depending on the strength of the data and whether additional information may be required for the evaluation. "Meanwhile we continue working on the continuous evaluation procedure -
rolling review
- in three other monoclonal antibodies and three immunomodulators, and their reviews are progressing well;
committee views for some of them could come in the next few weeks. "
According to the criteria of The Trust Project
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