NBC News
The Food and Medicines Administration (FDA, in English) plans important changes in the way in which vaccines against COVID-19 will be distributed and who can receive the updated doses this fall.
In an article published on Tuesday in the New England Journal of Medicine magazine, the FDA Commissioner, Dr. Marty Makary, and Dr. Vinay Prasad, new FDA Vaccine Chief, wrote that any new vaccine against the COVID-19 must now be subjected to clinical trials controlled with placebo, which means that some people would receive the real vaccine Inactive, as an injection of saline solution, to compare the results.
At a meeting scheduled for Thursday of the FDA vaccine panel, the agency advisers are expected to advise vaccine manufacturers on the strains to which the new vaccines should be directed. The new requirement of clinical trials is not expected to affect the autumn launch for older adults and other people with high risk of serious illness, since medication manufacturers are exempt from additional tests for these groups.
Makary and Prasad said in a question and answers session held Tuesday that annual vaccines for healthy children and adults would no longer be approved routinely. They also suggested that vaccines may not be updated every year.
“Instead of having a strategy against COVID-19 that is repeated year after year, why don’t we let science tell us when we should change?” Said Prasad. “The virus has no calendar.”
Previously, updated vaccines against COVID-19 had been authorized by the FDA similar to flu vaccines.
Original vaccines against COVID-19, from Pfizer and Modern, approved by the late 2020s, were subjected to placed controlled tests. Next, drug manufacturers went to smaller studies to check the effectiveness of updated vaccines in the activation of the immune response against the variants currently circulating in the United States.
In the magazine article, Makary and Prasad questioned the model of the flu vaccine, noting that only a quarter of the American population is vaccinated every year with updated vaccines, including less than one third of health workers.
In comparison, about 75% of workers were vaccinated against seasonal flu, according to data from disease control and prevention (CDC, in English).
The Vaccination policy against COVID-19, the officials wrote, “it has sometimes justified that the American population is not sophisticated enough to understand the recommendations based on age and risk.”
“We reject this opinion”they added.
Dr. Jesse Goodman, a professor of medicine and infectious diseases at Georgetown University and former chief scientist of the FDA, agreed that people can understand their own health risks, but was skeptical of the new approach of the agency, stating stating that it limits the “freedom of choice” of people.
“What about the people who have family or high -risk family members or colleagues? “He wrote in an email.” What about people who do not have a high risk of suffering from a serious illness and want to reduce their risk of infection or the time they have to miss work? “
During the Internet transmission, Prasad said that “there is no high quality tests that show that putting a reinforcement dose to visit your grandmother protects it.”
Who can receive vaccines COVID-19?
According to the new FDA guidelines, drug manufacturers will have to carry out new rehearsals that follow up the participants for at least six months.
The main objective of the trials should be to demonstrate that vaccines help prevent the symptoms of COVID-19, according to the officials, with data that demonstrate an effectiveness of at least 30%. People who have had COVID-19 in the past must continue to be included in the essay to better reflect the general population, they said.
Medication manufacturers can still use smaller studies, known as immunogenicity studies, to obtain approval for adults 65 years of age or older, as well as for children and adults with at least one medical condition that puts them at greater risk of contracting COVID-19.
The FDA indicated that many people are considered high risk, including pregnant women and people with obesity or suffering from mental health disorders such as depression. Other conditions related to severe COVID-19 are diabetes, heart disease and asthma.
“Ultimately, these studies alone can ensure that the US repeated reinforcement strategy indefinite is based on evidence,” the officials wrote.
Estimates, they said, suggest that between 100 and 200 million people in the United States will have access to updated vaccines.
The FDA decision is produced before the meeting of the Advisory Committee on Thursday Vaccines, in which external experts will discuss what strains should be included in the next round of vaccines against COVID-19.
In informative documents published on Tuesday, members of the FDA staff wrote that updating the vaccines so that they adapt better to the strains currently could “Provide additional benefits” in anticipation of a rebound in cases during autumn and winter.
Change means that it will be almost impossible for Pfizer and Modern to complete the new rehearsals in time for the autumn season. In addition to carrying out essays, pharmaceutical companies will still have to design and recruit participants, which can also take several weeks or months.
Next, the data would have to be analyzed and approved by the FDA.
Nor is it clear what the change will mean for healthy children and adults who want to receive updated vaccines.
Dr. Paul Offit, director of the Vaccine Education Center of the Chiladelphia Children’s Hospital and member of the FDA Vaccines Advisory Committee, said that people considered “low risk” can also be affected by the virus.
“Low risk does not mean any risk”he said. “Anyone can be hospitalized and die from the virus.”
Goodman questioned why the FDA was making the change instead of the Independent Advisory Committee on Vaccines of the CDC, known as an advisory committee on immunization practices, which normally makes recommendations on who should receive vaccines against COVID-19.
“It is not clear why there was a weight reason for the FDA to intervene and advance to that usual and publicly transparent advisory process,” he said.
Kennedy’s influence on vaccines
A change was expected in the way in which vaccines against COVID-19 are updated. Earlier this month, the Secretary of Health and Human Services (HHS, in English), Robert F. Kennedy Jr., ordered that all new vaccines be subjected to clinical trials controlled with placebo.
Until Tuesday, it was not clear if the HHS considered that the updated Pfizer and Modern vaccines were “new vaccines” that required new clinical trials.
Government’s former health officials feared that the FDA, under Kennedy’s mandate, was taking measures to slow down the approval of vaccines.
During the weekend, the FDA approved the Novovax vaccine after weeks late. However, in an unexpected turn, the agency limited the use of the vaccine to people 65 years of age or older adolescents and adults with at least one medical condition that puts them at risk of suffering a serious illness. Normally, it is the CDC that makes recommendations about who should receive vaccines.
Makary had warned about the changes in the way the vaccines are tested and approved, and said last week that the agency would soon “reveal a broader frame.”
Kennedy has long opposed vaccines, including that of COVID-19.
In 2021, he presented a citizen petition in which he requested that the FDA revoke the authorization of Vaccines against COVID-19.
That same year, he described the vaccines against COVID-19 as “the deadliest vaccines ever manufactured”, citing rare cases of myocarditis in young men. Studies reveal that the risk of myocarditis is greater-and normally more serious-in people with Covid-19 infection than after the vaccine.
Last week, at an audience of the Senatorial Committee of Health, Education, Labor and Pensions, Kennedy also falsely said that the only vaccines proven against a placebo were vaccines against COVID-19.
This statement led the president of the Committee, Bill Cassidy, Republican for Luisiana, to suspend the audience to correct Kennedy.
“To record, that’s not true. Rotavirus, measles and HPV vaccines have been (evaluated in front of a placebo), and some vaccines are tested against previous versions. So, to record, to make it clear, ”said Cassidy, who is a doctor.
Kennedy is not the only health officer who has criticized Vaccines against COVID-19. Makary, Prasad, Dr. Tracy Beth Hoeg, Makary Special Advisor, and Dr. Jay Bhattacharya, Director of National Health Institutes, have also done so.
