peel back effect

U.S. lifts pause on Johnson & Johnson vaccine

By Tim Mastro
Posted 4/23/21

DOVER — The U.S. Food and Drug Administration and Centers for Disease Control and Prevention lifted an 11-day pause on Johnson & Johnson’s COVID-19 vaccine Friday, after scientific …

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U.S. lifts pause on Johnson & Johnson vaccine

Posted

DOVER — The U.S. Food and Drug Administration and Centers for Disease Control and Prevention lifted an 11-day pause on Johnson & Johnson’s COVID-19 vaccine Friday, after scientific advisers decided its benefits outweigh a rare risk of blood clot.

The Delaware Division of Public Health did not respond to a request for comment on how this will affect Delaware’s vaccine distribution. DPH officials said during a COVID-19 press briefing Tuesday they were hopeful to resume J&J vaccinations this upcoming week, including a J&J vaccination clinic at Dover International Speedway the weekend of May 1, pending Friday’s decision.

Delaware has received a total of 47,500 doses of the J&J vaccine — the only one-dose vaccine currently approved by the federal government. It has used 30,888 of those doses, as of Thursday at 11:59 p.m.

FDA and CDC officials decided Friday J&J’s one-does vaccine is critical to fight the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.

“Above all else, health and safety are at the forefront of our decisions,” CDC Director Dr. Rochelle Walensky said in a statement. “Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses” of the J&J shot and will continue to monitor them.

The government’s investigation uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.

The U.S. decision — similar to how European regulators are rolling out J&J’s shot — comes after CDC advisers voted 10-4 to resume vaccinations earlier on Friday, but panelists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.

The side effect debate isn’t the only hurdle facing J&J. The FDA separately uncovered manufacturing violations at a Baltimore factory the company had hired to help brew the vaccine. No shots made by Emergent BioSciences have been used — J&J’s production so far has come from Europe. But it’s unclear how the idled factory will impact J&J’s pledge to provide 100 million U.S. vaccine doses by the end of May and 1 billion doses globally this year.

Delaware has administered a total of 682,445 doses of vaccine, including two-dose vaccines Moderna and Pfizer, as of Thursday at 11:59 p.m.

More than 387,000 Delaware residents ages 16 and older have received at least one dose of the COVID-19 vaccine, representing nearly 50% of the currently eligible population in the state. More than 253,000 Delawareans are fully vaccinated, representing approximately 33% of the currently eligible population, using data for DelVAX, the state’s immunization information system.

A total of 281,652 individuals have been fully vaccinated in Delaware, this includes non-residents who are eligible to receive vaccinations in Delaware if they work in Delaware or access their healthcare in Delaware.

The vaccination news comes as Delaware is averaging 329.1 new positive cases of COVID-19 over the last seven days. The most recent seven-day rolling average for the percentage of positive tests is at 5.7% as of Tuesday at 6 p.m., a decrease from 6.5% the Tuesday prior. There is a two-day lag for presenting percent-positive data to account for the time delay between the date of the test and the date the DPH receives the test result.

COVID-19 hospitalizations are at 168 in the DPH’s most recent report, as of Thursday at 6 p.m. That is a decrease of 12 compared to the day prior, but an increase of 23 compared to a week ago. Of those hospitalized, 21 cases are considered critical.

Five additional COVID-19-related deaths were announced by the DPH on Friday, bringing the state’s total to 1,609. Three were from Sussex County while one each was from Kent County and New Castle County. One did not have underlying health conditions while another was a resident of a long-term care facility — the 742nd COVID-19-related death in a long-term care center.

The Associated Press contributed to this story.

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