“Although the totality of the data currently suggests that the signal … is very unlikely to represent a true clinical risk, we believe it is important to share this information with the public, as we have done in the past. , when one of our security monitors detects a signal,” the statement read.
The real-time monitoring system, CDC’s Vaccine Safety Datalink, met criteria for further investigation into whether the bivalent Pfizer vaccine leads to a higher risk of ischemic stroke, which occurs when the arteries that pump the blood to the brain are blocked by a blood clot.
Pfizer and BioNTech said in a statement that there is “no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
The announcement prompted a response from the chairman of House Energy and Commerce Cathy McMorrisRodgers (R-Wash.), who said the CDC and FDA will testify before his committee.
“These agencies must promptly investigate, in an open and transparent manner, whether or not the vaccine may have contributed to the reported strokes,” McMorris Rodgers said in a statement. “If there is one lesson the CDC and FDA should have learned from the pandemic, it is the importance of providing honest, clear, accurate, and timely information to the American people about the potential risks and benefits of COVID interventions. -19, including vaccination. .”
The announcement comes as the Biden administration has actively promoted the updated vaccine to older Americans.
People over the age of 65 are most at risk of severe illness from Covid, including hospitalization and death, and CDC data shows that 70% of average daily new hospitalizations of patients with confirmed Covid-19 over the past week were aged 60 and over.
According to the CDC, less than 40% of people over the age of 65 have received the booster which became available in the fall, despite the administration’s six-week push to increase vaccination in this age group before the vacation. Ninety-four percent of the elderly received both main series messenger RNA injections.
Millions of doses of messenger RNA Covid vaccines made by Pfizer-BioNTech and Moderna — the agencies said the Moderna vaccine was not flagged by its oversight — have been administered in the United States, and federal health officials have repeatedly deemed them safe and effective for use in anyone 6 months and older.
Yet rare but serious side effects – which can occur with any pharmaceutical product – have emerged since the vaccines were launched.
The data showed an elevated risk of myocarditis and pericarditis – inflammation of the heart muscle and membrane, respectively – after the second dose of mRNA vaccine in men aged 12 to 39, people at the end of teens and twenties being the most affected. The condition can also occur after infection with Covid and other conditions and tends to be more severe in those cases, and the FDA and CDC say the benefits of vaccination outweigh the risks.
Federal authorities suspended the use of the Johnson & Johnson single-dose Covid vaccine for 10 days in April 2021, just weeks after its debut, after the vaccine’s adverse event monitoring systems detected a possible link between a condition severe blood clotting and injections.
The FDA later discovered that approximately 15 percent of cases of thrombosis with thrombocytopenia syndromeknown as TTS, were fatal, with the highest reporting rate among women aged 30-49. This vaccine, made with a different technology, has largely fallen out of favor in the United States in favor of mRNA injections, with the FDA limiting the use of the J&J vaccine in May 2022 in adults who cannot or do not want to obtain the products. Pfizer or Moderna.