Health
The CDC panel states that the benefits of the J & J COVID-19 vaccine outweigh the risks
- The CDC Vaccine Advisory Board has reviewed cases of rare neuropathy in some people who received the Johnson & Johnson vaccine.
- As of June 30, there were 100 cases of Guillain-Barré syndrome reported through the Johnson & Johnson CDC Vaccine Safety Monitoring System.
- This is 8.1 cases per million doses administered, which is higher than the expected 1.6 cases per million doses in the general population.
Despite reports of rare but serious neuropathy after vaccination, a US Centers for Disease Control and Prevention (CDC) advisory group said Thursday that the benefits of Johnson & Johnson’s COVID-19 vaccine “exceeded risk.” I’m continuing. “
As of June 30, there were 100 cases of Guillain-Barré syndrome reported through the CDC’s Vaccine Safety Monitoring System.
This is 8.1 cases per million doses administered, which is higher than the expected 1.6 cases per million doses in the general population.
It is also about eight times the rate of Guillain-Barré syndrome found with the Pfizer-BioNTech and Moderna-NIAID vaccines.
Cases reported to the Vaccine Adverse Event Reporting System (VAERS) need to be examined in more detail to confirm that they meet this definition of neurological condition.
Guillain-Barré Syndrome Rare obstacles The immune system accidentally attacks the nerves of the body.
Symptoms include weakness and tingling in the extremities, difficulty with facial movements and walking, vision problems, and difficulty controlling the bladder and intestines.
This condition can also occur after a respiratory or gastrointestinal infection.
Of the 100 cases of Guillain-Barré syndrome reported through VAERS, 95 were hospitalized, according to a slide presented Thursday. Ten patients were intubated and / or required mechanical ventilation and one died. The other five cases were not serious.
Most cases occurred in people aged 18-64 years within 42 days of vaccination. In addition, 61% occurred in men.
ACIP member
But “I have no problem [J&J] “Products available,” he added. “But I think those risks must be stated in advance to those who are vaccinated.”
The ACIP review of these cases took place approximately a week after the Food and Drug Administration (FDA) updated the J & J vaccine fact sheet to include a warning about the risk of Guillain-Barré syndrome within 42 days of vaccination. increase.
On July 12, the FDA updated both fact sheets
ACIP Chair Dr. Jose Romero said single-dose J & J vaccines are an important tool for addressing recent problems. undulation COVID-19 cases and hospitalization rates — almost all are found in unvaccinated people.
“To get out of this situation, the availability of a single dose vaccine is very important,” he said, noting that some “individuals do not return with a second dose” of the mRNA vaccine.
Dr. Peter Marks, director of the FDA’s Center for Biopharmaceutical Evaluation and Research (CBER), said: video The benefits of being vaccinated on Twitter far outweigh the risks of rare side effects such as Guillain-Barré Syndrome.
“COVID-19 is very realistic and unfortunately we still have a lot left. Comeback [in the United States]”Therefore, it is advisable to get vaccinated if you are not vaccinated, especially if you are in an area with low vaccination rates.”
The CDC Vaccine Advisory Board also discussed the potential dose of COVID-19 vaccine booster for immunocompromised people.
These people are at high risk for severe COVID-19 and may not produce a less powerful immune response to standard vaccination regimens.
At a meeting on Thursday, CDC staff suggested that both regulated and unregulated approaches were needed to keep immunocompromised people safe from COVID-19.
Currently, with FDA urgent approval, people can be vaccinated once with the J & J vaccine or twice with the mRNA vaccine.
The FDA needs to change the current Emergency Use Authorization (EUA) so that booster doses can be given. Another route is full FDA approval, which allows physicians to “off label” recommendations for boosted immune doses.
FDA liaison Dr. Doran Fink During the meeting, authorities said they did not yet have data on vaccines to support regulatory measures that would allow booster doses.
Some studies have already investigated the benefits of booster doses for people with immunodeficiency.
ACIP reviewed several studies during the meeting and 33-50% of immunocompromised people who did not show a detectable antibody response to two mRNA vaccine doses responded after the third dose. I found that.
However, without the FDA’s decision on boosters, some immunocompromised people “take the problem in their own hands” and “promote additional vaccines that appear appropriate,” said ACIP members. .. Dr. Camille Cotton, Of Massachusetts General Hospital in Boston.
Until and perhaps even after booster doses became available to immunocompromised people in the United States, the CDC wore face masks while these people were in indoor public spaces, physically separated and crowded. We recommend that you continue to take other precautions, such as avoiding it.
The agency also states that vaccination of COVID-19 itself will help family and close friends to protect people with immunodeficiency.
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