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US Health Officials to Allow J&J Vaccine With Side Effects Warning

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Eleven days ago, the Centers for Disease Control and Prevention and the Federal Drug Administration pulled the Johnson & Johnson Janssen vaccine after a few women suffered extremely rare but serious blood clots after being vaccinated. On April 23, 2021, the health officials lifted the pause but will issue a fact sheet about the aforementioned side effect.

Earlier in the day, the Advisory Committee on Immunization Practices revealed they had determined the U.S. should resume using J&J COVID-19 vaccines. Panel members voted 10 to 4 to recommend lifting the pause but added they suggested the CDC and FDA add a warning. One of the 15-panel members abstained due to a conflict of interest.

vaccineDr. Jose Romero, chair of the panel and the director of the Arkansas Health Department said:

“Removing a vaccine that can be given in a single dose and is a preference among Latinos in our communities would be a detriment.”

The Director of the FDA Center for Biologics Evaluation and Research Dr. Peter Marks said vaccines should be able to resume as early as tomorrow morning.

He added, the FDA had been preparing updated fact sheets over the past few days so they would be ready when the vaccine would once again be available to the public.

Marks said the warning sheets were approved and easily accessible via the internet and print on demand. These will alert doctors and hospitals to look out for complications and understand how to treat them effectively. The doctors also need to know that a regularly used blood thinner – heparin — appears to make the conditions worsen.

Post-COVID-19 Vaccines Reported Blood Clot Cases in the United States

On April 13, the CDC and FDA recommended temporarily halting the Janssen vaccine due to the aforementioned blood clot cases out of more than 7 million individuals who had been vaccinated. Since then, reports of nine additional cases along with new information surfaced said Dr. Tom Shimbukuro, a member of the CDC’s Vaccine Task Force. He added there are 15 confirmed and a handful of unconfirmed cases under review.

The rate of occurrences is 11.8 per million doses of the Janssen COVID-19 vaccines administered. Cases breakdown:

  • Of the 15, three patients have passed away and seven others remain in the hospital.
  • All cases were in women.
  • All but two were women ages 18-50.
  • Seven women were in their 30s.
  • No medical conditions or medications link the cases, including birth control pills or obesity.

Professor of Pediatrics at Stanford University School of Medicine Dr. Grace Lee explained it is encouraging that the last 11 days did not include hundreds of confirmed cases despite the increased awareness of the rare but serious blood clots.

Dr, Helen Talbot, an associate professor of medicine at Vanderbilt University in Nashville, Tennessee expresses concern about the likelihood that there might be confusion over the COVD-19 vaccine-related event with those of oral contraceptives. The doctor added the types of blood clots are quite different as are the treatments.

Johnson & Johnson vows to work with the federal regulators to make sure this rare event can be identified early and effectively treated.

We remain committed to the health and safety of people worldwide.

Written by Cathy Milne-Ware

Sources:

NBC News: U.S. should resume J&J vaccinations with warning notice, CDC advisory group says; by Sara G. Miller and Ericka Edwards
ABC News: CDC, FDA lift pause on Johnson & Johnson vaccine with warning of risks

Featured and Top Image by Edwin J. Torres/NJ Governor’s Office Courtesy of Phil Murphy’s Flickr Page – Creative Commons License
Inset Image by Art Writ Courtesy of  VCU Capital News Service’s Flickr Page – Creative Commons License

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