Everything we know about Pfizer’s Covid-19 vaccine for children under 5

Pfizer and BioNTech They announced this week that they will begin the process of requesting the U.S. health regulator to authorize the emergency use of the Covid-19 vaccine for children older than six months and younger than five years, given the increase in infections. the population, mainly due to the presence of the variant Omicron of the coronavirus.

The rate of hospitalization of children under 5 years of age with Covid-19 in the United States, it began to rise in mid-December and peaked in early January, according to data from the U.S. Centers for Disease Control and Prevention (CDC). As of January 22, however, weekly data still showed that more than seven out of 100,000 children in that age group were hospitalized; more than three times the rate of hospital admissions for children and adolescents from 5 to 17 years.

According to data from the American Academy of Pediatrics, more than 3.5 million new cases of COVID-19 infections were reported in January 2022. Covid in minors.

Here we share what has been known so far about the Pfizer and BioNTech Covid-19 vaccine for children under 5 years:

• Pfizer and BioNTech have begun submitting data from their clinical trials to the Food and Drug Administration (FDA for its acronym in English) and expects to complete the process within a few days to obtain authorization for the emergency use of its Covid-19 vaccine for children older than six months and younger than five years.
• The US laboratory and the German biotechnology company continue to investigate what the appropriate dose will be for the population of children older than six months and younger than five years and the number of injections they will need to guarantee its effectiveness against the coronavirus and the variants that have emerged.
• The pharmaceutical company explained it intends to initially give injections that contain a tenth of the dose of the vaccine administered to adults.
• The executive director of PfizerAlbert Bourla said on Tuesday that company scientists believe that this age group will need three of the “extra-low” doses (three micrograms), but that the FDA’s initial authorization for the two-dose application will allow parents to begin the process of vaccination while awaiting a final decision on the number of doses to be given.
• In December, Pfizer expanded clinical trials of its vaccine in younger children. However, the administration of two doses could not produce the expected immunity in children older than two years and younger than five years. Only infants aged six months to two years showed some degree of immune response. Given this, the specialists decided to try the administration of a third dose.
• The FDA Advisory Committee will meet on February 15 to discuss Pfizer and BioNTech’s request for emergency use of their Covid-19 vaccine for children aged six months to four years.
• FDA authorization could pave the way for younger Americans to start receiving the flu vaccine. coronavirus SARS-CoV-2 in late February and early March, US media reported.
• The vaccine developed by Pfizer and BioNTech will be the first biological remedy available to children six months and younger than five years.
• Pfizer’s biological agent already has FDA authorization to be used in children 5 to 11 years old.

What will the FDA analyze to authorize vaccination for children under 5 years of age?

• The results of the Pfizer-BioNTech clinical trial.
• The data relate to the efficacy according to the proposed “amount of the dose”.

“In phases 1 and 2 of the clinical trials you see what the required dose is, we talk about whether it is 0.5 milliliters, etc. and how many doses are required. In the case of children, as seen with others vaccines, sometimes different doses are needed, with more or less of the antigen, depending on the vaccine. “For example, the tetanus vaccine in children has twice the antigen as the stimulant vaccine given to adults, because the immune response differs between children and adults,” said Dr. Rodrigo Romero Feregrino, coordinator of the Mexican Vaccine Association.

“Then in the first phases of the investigation it is reviewed, it is seen which is the most suitable dose with which they have the best reaction, therefore it took a little longer,” said Romero.

Children under six months and up to 5 years old would be the last segment of the population to have the coronavirus vaccine worldwide, and the need to vaccinate them has become increasingly urgent due to the fact that the Omicron variant has affected this sector in a more serious way.

“The need for a safe and effective vaccine for our youngest children is significant, especially given the rapid spread of the disease. Omicron variant, the marked increase in the number of hospitalizations in young children with serious illnesses and the possibility that future variants may cause serious illnesses. disease in those who have not been vaccinated, ”said Peter Marks, director of the Center for Biological Evaluation and Research of the FDA.

Despite the US government’s rush to vaccinate this sector of the population, it remains to be seen whether the parents’ response will be vaccines despite its approval by health regulators.

According to a survey released by the Kaiser Family Foundation on Tuesday, more than two-thirds of parents of girls and boys in this age group responded that they would wait and see the vaccination or that they “definitely” did not plan to vaccinate their children. Almost a third of parents say they will be vaccinated your babies and toddlers right away.

Why is it advisable to vaccinate minors against Covid-19?

Andreu Comas García, research professor at the Faculty of Medicine of the Autonomous University of San Luis Potosí (UASLP), explained that it is important to take into account that minors represent a population with “three important characteristics” within the transfer dynamics of the contagious diseases:

• They are a highly mobile population within the community.
• They are the population with the highest rate of contact between individuals.
• They are the population with a high incidence of new infectious diseases.

The specialist explained that this sector of the population “is an important source of spread and infection of diseases such as Covid-19“.

“For the coronavirus to act seasonally, more than 88% of the entire population is required to be vaccinated and the only way to achieve this is to immunize minors as well,” Comas García explained.

Benefits of vaccinating girls and boys against Covid-19

• Decrease in the burden of illness in minors. Helps reduce incidence, mortality, hospitalization and medication use; in addition to preventing school absenteeism and absenteeism from their parents or caregivers.
• Reduce coronavirus transmission at community level. The vaccination of minors makes it possible to mitigate the size, speed and impact of the epidemic.
• Establish the “cocoon strategy” to protect the vulnerable or unvaccinated population
• Helps avoid further consequences after suffering from Covid-19.
• Softens the viral reservoir in humans. “Although it is not possible to eradicate or eliminate the coronavirus, its presence in humans can be limited so that it occurs seasonally in temperate places and endemically in tropical places,” explained Andreu Comas García.
• This will enable the massive reactivation of activities involving minors, such as face to face classes.
• Reduce the selective pressure against Covid-19 by preventing the emergence of variants that escape the immune system or variants with a better capacity to replicate or prevent over.