Boston, Massachusetts 2021-10-23 09:10:25 –
NSFood and Drug Administration Scientist Presented the analysis At the end of Friday, the protection provided to children ages 5 to 11 by the Covid vaccine developed by Pfizer and BioNTech Myocarditis, Heart-related side effects that the vaccine may cause.
FDA analysis published Prior to Tuesday’s meeting Of outside scientists gathered to make recommendations on granting vaccines to children in that age range. The agenda of the conference presents a session focusing on the effectiveness of the vaccine and the potential risk of myocarditis, an inflammation of the heart. The FDA is not bound by an advisory board vote, but generally follows their advice.
New data from Pfizer It was also released on Friday. They show that the vaccine is about 91% effective in preventing Covid-19 aged 5-11 years.
“While the benefits of vaccination were highly dependent on the incidence of Covid-19, the overall analysis showed that the number of clinically significant Covid-19-related outcomes prevented was determined by Covid’s various assumptions. It was predicted to clearly exceed the number of cases of vaccine-related excess myocarditis in. -19 Incidences, “the agency researcher wrote.
However, researchers pointed out that if the incidence of Covid-19 drops to the levels seen in June 2021, there will be more cases of vaccine-related myocarditis than hospitalization with Covid-19. .. However, FDA staff still said, “The overall benefits of the vaccine may still outweigh the risks in this low-incidence scenario,” given the more serious nature of hospitalization with Covid-19. Said.
Much of the Commission’s discussion may focus on the benefits of vaccines. This dramatically reduces the chances of a child being infected with SARS-CoV-2, the virus that causes Covid-19, and its potential risk. In older boys and younger men, the vaccine is associated with myocarditis. Estimates of risk vary, but occur in approximately 1 in 10,000 boys and men between the ages of 16 and 19 who receive a second dose.
New data from the briefing document show that the Pfizer / BioNTech vaccine not only reduces the risk of infection, but also reduces the risk of symptomatic Covid-19 in children infected with SARS-CoV-2. Of the 1,518 children in the vaccinated study, there were 3 cases of symptomatic Covid-19. Of the 750 children who received placebo, 16 had the disease. In other words, the effect of the vaccine was 90.7%. Previously, only data on the ability of children to produce antibodies to Covid-19 after vaccination were available, not their effectiveness in disease prevention.
The symptoms of the vaccinated children were very mild. No one had a fever. In contrast, 10 out of 16 unvaccinated children who developed Covid-19 developed fever. Common side effects were similar to those commonly caused by adult vaccines and included headaches and fever. Pediatric shots are 10 micrograms, or one-third of the adult dose.
Of the volunteers in this study, 52% were male, 79% were white, 6% were black, and 6% were Asian-American.
The data were also included in an expanded group of 1,591 additional children who received the vaccine and another 788 who received placebo, all of which were not followed for 2.5 weeks. For these children, the information is only available for side effects. The FDA seems willing to make decisions about vaccines without the data from this extended trial.
Since children are unlikely to experience the serious consequences of Covid-19, the panel may discuss whether the benefits of protection outweigh the small risk of myocarditis or other side effects. Covid-19 itself can cause myocarditis at a much higher rate than vaccines.
Too few young people have been treated to get a clear picture of the risk of myocarditis. Researchers still don’t fully understand why it happens. Some patients with vaccine-induced myocarditis needed intensive care, but the FDA said most patients resolved their symptoms with “conservative management.”
Myocarditis rarely occurs in clinical trials, so it is difficult to accurately estimate its frequency. In a briefing document, the FDA stated that myocarditis and pericarditis, and associated inflammation of the inner wall of the heart, were reported to the U.S. government’s Vaccine Adverse Event Reporting System (VAERS) 71.5 per million vaccinated men aged 16 to 17 and 42.6 per million men aged 12 to 15 years, approximately 1 per 12,000 men aged 16 to 17 , Equivalent to 1 case per 24,000 people. For 12 to 15 years old.
However, the FDA also analyzed a database of claims from Optum, which is part of the insurance company UnitedHealth Group. According to the database, the estimated excess risk of myocarditis and pericarditis approaches 200 per million for fully vaccinated men aged 16 to 17 years and 180 per million for vaccinated men aged 12 to 15 years. I did. This is about 1 in every 5,000 vaccinated boys.
But the question is not just what the risk of myocarditis is, but whether the benefits of the vaccine outweigh the risk. And the benefits of vaccination of someone depend on how many cases of Covid-19 are occurring.
The FDA has modeled the number of hospitalizations that can be prevented by vaccination of 1 million boys between the ages of 5 and 11 at six different points in the pandemic. In most cases, the vaccine will prevent 200 to 250 hospitalizations per million vaccinated boys. However, at some point, in June 2021, when cases plummeted nationwide, the vaccine would have prevented only 21 hospitalizations per million boys.
At any given time, the number of hospitalizations for myocarditis caused by the vaccine is the same. The FDA estimated 98 hospitalizations per million vaccinated boys. Therefore, the number of Covid-related hospitalizations prevented is usually twice the number of hospitalizations for myocarditis, even in the highest-risk group. However, if the virus is controlled, the number of myocarditis-related hospitalizations for boys in this age group will be slightly higher than the number of Covid-related hospitalizations, as there are very few cases of Covid-19.
This condition is less common, as the FDA still claimed that the outcome of patients admitted with Covid-19 was worse than that of patients with myocarditis and chose to model a high rate of myocarditis. There is a possibility.
of Pfizer briefing document The company, which became available prior to the meeting, quoted data from Israel. Vaccines are primarily used in Israel, and data on myocarditis are closely tracked.
In these data, Pfizer states that the risk of myocarditis after the second dose in boys aged 12 to 15 years is 1 in 12,000, which is about half that in men aged 16 to 19 years. It is based on 12 cases that occurred in 255,444 adolescents. .. Only one of those cases was in female vaccine recipients.
Pfizer said in its document that vaccination of 1 million children aged 5 to 12 would result in 33,600 hospitalizations in 120 days, assuming that the 90% efficacy figure of the vaccine would be maintained. It states that it can prevent 170 deaths. During the same period, 21 cases of myocarditis or pericarditis occur.
NS Draft agenda At the meeting on Tuesday, the Commission has indicated that it will consider a presentation on myocarditis and other risks, and the benefits of the vaccine. According to the briefing document, the panel will consider whether the benefits of a double-dose vaccine outweigh the risks of using it in children aged 5 to 11 years, based on a whole set of scientific evidence.
If the FDA decides to approve the vaccine, its use will be assessed by another panel convened by the US Centers for Disease Control and Prevention. The committee also recommends its use, and if the CDC director agrees, the vaccine will be available.
Damian Gard contributed to this article.
FDA scientists say benefits of Pfizer Covid-19 vaccine ‘clearly outweigh’ the risks for children ages 5 to 11 Source link FDA scientists say benefits of Pfizer Covid-19 vaccine ‘clearly outweigh’ the risks for children ages 5 to 11