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"The four vaccines approved so far in the European Union provide high protection against all the SARS-CoV-2 strains that are in circulation
at the moment, especially in preventing serious illness and admission from developing." This was stated today by
Marco Cavaleri,
head of Biological Products and Vaccine Strategy of the European Medicines Agency (EMA), in an appearance to update the body's work in the pandemic, the last scheduled until September, if there are no new incidents to report .
According to Cavaleri, as expected, preliminary data suggests that in the case of
the approved two-dose
vaccines - Comirnaty, from Pfizer and BioNTech; Spikevax, from Moderna, and Vaxzevria, from AstraZeneca -
the two doses are necessary to provide adequate protection against the delta variant
, which makes "even more important to insist that the population complete the vaccination schedule as soon as possible, and that the interval between the two doses is the closest to the one recommended in each case ".
It is too
early to know if a different vaccine will be necessary or the adaptation of one of those available to deal with this variant
, "although work is already being done to study vaccine variations, and the EMA is very committed to the companies to establish development programs that allow the gathering of sufficient clinical information to take any future regulatory action ".
The head of the EMA's Vaccine Strategy has also pointed out that "given the rapid spread of the highly contagious delta variant, which is generating concern not only in Europe but throughout the world, it
is extremely important to vaccinate as many people as possible
, as recommended at the national level in each of the countries. "
He recalled that in a joint statement by the EMA and the European Center for Disease Control and Prevention (ECDC), both organizations warned precisely about the current pandemic situation, and
"we encourage the population to protect itself by ensuring that you complete your vaccination schedule
.
"
Possible booster dose
The aforementioned statement also
points to the possibility that a booster dose may be necessary after the vaccination cycles established so far
. "At this moment," Cavaler said, "it is too early to confirm whether this dose will be necessary, or when it should be raised, because there is still not enough data from the vaccination campaigns or the ongoing studies to conclude how long the protection will last. of the vaccines, also considering the impact of the dispersion of the variants. The EMA, in any case, will review all these data as soon as they are available. "
On the other hand, Cavaleri also presented some of the conclusions of the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which met last week.
"After careful review of all the data available so far, the PRAC has concluded that
myocarditis and pericarditis can occur in very rare cases after vaccination with Comirnaty.
and Spikevax.
The product information in both cases will be updated to include these two very rare side effects of these vaccines as possible.
It is important that healthcare professionals and people to be vaccinated are aware of these risks and are aware of possible symptoms of myocarditis or pericarditis. "
"However, the available data suggest that
the course of both conditions
when they occur after vaccination usually
improves rapidly with rest or treatment
, as in the typical forms of these pathologies."
For all vaccines, the
EMA will continue to monitor
their safety and efficacy and provide timely information, especially
as more adolescents and young adults are vaccinated
and more doses are administered, and will make the necessary decisions if any risks are identified. .
Disinformation
Cavaleri has specifically addressed the
misinformation and misinformation that circulates on the internet
about the safety of vaccines, "and even sometimes with disavowal of official and regulatory decisions in favor of anti-vaccine movements", recalling that
the official source on the safety of
vaccines
vaccines in the EU are
the agency's
adverse reaction reports (ADRs)
. In them, "the EMA collects all cases of reported adverse effects, including those that have resulted in death."
"In any case," he added, "these reports collect suspicions or events that occurred after vaccination, but it is important to note that
the fact that an event or even death occurs after vaccination does not necessarily mean that it is a consequence of it
, and that these effects may have been produced by underlying problems of the patients, until then unknown ".
The EMA and EU member states continue to
monitor these cases to update vaccine safety information.
"We are committed to ensuring that any potential effects are investigated quickly so that we can build confidence in vaccines with a solid scientific basis."
Medications are also needed
Finally, Cavaleri stressed that, along with the important progress made with available vaccines,
"we also need drugs to treat and save the lives of those who become infected
, and to control the pandemic. We support this need by expediting the review of promising treatments", among which there are several subjected to the
rolling revie
w procedure, or continuous evaluation.
"Right now -HA recordado-,
they are being evaluated
by this procedure both
Olumiant
-baricitinib-, from Lilly, as four monoclonal antibodies or combinations of antibodies
, whose reviews will continue until there is sufficient data for their eventual approval, expected by the end of the year. "
"The positive thing -he concluded- is that
there is an
extensive and active
pipeline
of drugs against Covid-19,
both to treat patients with the disease that do not require hospitalization and those who do need admission, and we hope that some of these agents progress throughout this year. The EMA will maintain an active dialogue with the companies developing these products to ensure that the clinical information necessary for subsequent agile approval is generated. "
Finally, Cavaleri recalled that the Committee for Medicinal Products for Human Use of the EMA is
evaluating an application
to expand the indication of the
Spikevax
vaccine
to include the population between the ages of 12 and 17
, and expects the final decision to come by the end of next week.
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