Children under 12 in the United States should be able to get vaccinated by the end of the year, US government officials and Pfizer estimate, amid calls for the process to be sped up.
The American laboratory conducts studies on the application of the immunizing agent in babies and children from six months of age. The release must take place first for those over the age of five.
“We are in a position to send the data [dos estudos] to the FDA [órgão federal que aprova os medicamentos] in September, and submitting the application for approval in early October, which puts us on a schedule where the vaccine could be available in late fall, most likely early winter [dezembro], depending on how long the FDA takes to review the application,” Scott Gottlieb, who serves on Pfizer’s board of directors, told CBS TV on Sunday.
In recent interviews, Anthony Fauci, the top US infectious disease specialist, has estimated that the FDA will have all the necessary data by October and that release of doses could take place before the year-end holidays.
Moderna also conducts studies on immunization for children, but it will take longer to complete.
The US is experiencing a new high in Covid cases as children start the school year. Most schools are resuming classes in person, and vaccination can help prevent new outbreaks of the disease.
In the week of August 19-26, there were 204,000 new cases of infected children in the US. A month earlier, this average was 38,000 weekly infections.
Despite the discharge, hospitalizations and deaths by Covid in this age group remain very low. In the US, 141 children under 4 years old and 313 between 5 and 18 years old have died from the disease, according to the CDC (Center for Disease Control), since the beginning of the pandemic. Altogether there were almost 640 thousand deaths by Covid-19 in the country.
In May, the US released the application of the Pfizer vaccine to people over 12 years old, and the expansion of immunization to younger people depends on the results of clinical studies.
The FDA has been more judicious in analyzing immunizations for this age group. In July, the agency ordered Pfizer and Moderna to double the number of children participating in the studies and extend the time over which they would be followed, from two to six months.
“Since cases of severe Covid are rare in children, it is necessary to carry out broader studies, as the possible side effects will also be more difficult to find”, explains Renato Kfouri, pediatrician and director of the SBIm (Brazilian Society of Immunizations).
“The percentage of deaths in children is low, but in Brazil we had around 2,000 deaths by Covid of children under 20 years old. It’s less than 1% of the total, but there are 2,000 preventable deaths, caused by a disease that already has a vaccine”, he ponders.
In the US, as vaccination progresses among adults, children start to concentrate a greater number of cases. In the sum of data since the beginning of the crisis, they represent 14.6% of infections, according to data from the AAP (American Association of Pediatricians), but in August they became 22.4% of newly infected.
The AAP advocates that the release be made faster, as it assesses that the benefits of starting child immunization soon will be much greater than any possible risks.
“Waiting for the six-month follow-up will significantly hamper the ability to reduce the spread of the hyperinfectious delta variant,” the organization warned in a public letter.
One of the points that raised concern was the occurrence of cardiac inflammation, such as myocarditis and pericarditis, in adolescents who received mRNA vaccines, such as those from Pfizer and Moderna. A study, completed in June, showed that the problem particularly affected boys over 16 years of age, but at a very low rate: 12.6 cases per million doses applied. The symptoms disappeared after a few days.
The US began vaccinating teenagers in May and was followed by several countries in the following months, including Canada, Chile, France, Israel, Italy, Japan, Mexico and New Zealand, among others. In Brazil, only Pfizer’s immunizing agent was approved for use in children and adolescents aged between 12 and 17 years.
In June, China was the first country to approve the use of a Covid vaccine for children. Sinovac, which produces Coronavac, has obtained authorization to immunize children as young as three years old. And, at the beginning of August, the UAE released the use of Chinese Sinopharm’s vaccine for the same band.
In August, Anvisa denied authorization for the application of Coronavac in Brazil for people aged between 3 and 17 years. The agency said that studies were lacking to prove the drug’s effectiveness in this age group.