The covid-19 vaccine from Pfizer-Biontech To be applied from six months of age, it could be ready no later than December of this year, Rodrigo Sini, Director of Vaccine Medical Affairs for Latin America at Pfizer, told Excelsior.
After last May, the emergency use of this biological for people between 12 and 15 years of age was authorized by the United States Food and Drug Administration (FDA) and by the European Medicines Agency (EMA) , the pharmacist works in phase 2 and 3 to verify the safety, tolerability and efficacy in population groups under 12 years of age.
In fact, immunization for children between the ages of two and five is expected to be ready in September.
“The studies are divided into subgroups: from six months to two years; from two years to five years and from five years to 11 years.
“We already have primary results in terms of safety and tolerability to know the dosage that we are going to use in these three age groups and we have already started phase 2 and 3 studies to measure efficacy, of which we hope to have results during 2021.
“At the end of September from 5 to 11 years old. And we wait until the end of November and December, from six months to five years of age ”, he explained.
From Brazil, in a virtual interview, Rodrigo Sini, Director of Vaccine Medical Affairs for Latin America at Pfizeradded that his vaccine against covid-19 it is safe for the entire population because anaphylaxis (allergic reactions) are minimal.
“After the application of 700 million doses, it is proven that the cases of anaphylaxis are lower than in the general population, therefore, the safety of the vaccine is greater and the importance of getting vaccinated,” he explained.
Rodrigo Sini added that the biological is also being tested in pregnant women and in patients with some type of immunosuppression.
However, he clarified that it can currently be used in patients with HIV.
“And we are also including studies with pregnant women and with patients with some type of immunosuppression, because in the first studies we included people with chronic diseases, for example stable heart disease, diabetics and people with hepatitis B and C, but in this study they are transplant patients or cancer patients ”, he pointed out.
Vaccine for children 12 years and older awaits authorization
In our country, the vaccine against coronavirus from Pfizer-Biontech, is awaiting your authorization for emergency use from 12 years of age.
The outlook for its approval is optimistic, after last June 11, the Committee of New Molecules and the Subcommittee for the Evaluation of Biotechnological Products, of the Federal Commission for Protection Against Sanitary Risks, (Cofepris) recommended its application for this sector of the population.
“The Committee for New Molecules (CMN) and the Subcommittee for the Evaluation of Biotechnological Products (SEPB) met this morning to issue a technical opinion on the extension of the age group from 12 years, for the application of the BNT162b2 vaccine (Pfizer- BioNTech COVID19 vaccine), which received a unanimous favorable opinion, ”reported Cofepris.
Therefore, if Cofepris supports the extension of the emergency use requested by Pfizer, the vaccine against the SARS-CoV-2 virus would have to be included in the National Vaccination Plan to be used in the population from 12 years of age, since its application is currently endorsed from the age of 17.
In this regard, Rodrigo Sini, Director of Vaccine Medical Affairs for Latin America at Pfizer, pointed out that in all population groups – from 12 years of age – the biological is applied in the same way for children, youth and adults.
“The same dosage was used as the other age ranges. 30 micrograms in two doses over a three-week interval were used in all studies and this was also done in this population.
“So today, in summary, the authorization for people over 12 years of age are two doses of 30 micrograms in a minimum interval of three weeks,” he stated.
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