- The Washington Times - Sunday, April 25, 2021

National Institutes of Health Director Francis Collins on Sunday said federal regulators and advisers made the right call in resuming the Johnson & Johnson vaccine for everyone, saying its benefits in fighting COVID-19 outweigh the threat of rare blood clots seen in a handful of recipients.

“There’s no comparison. We clearly have a situation where the benefits greatly outweigh the risks, even for younger women,” Dr. Collins told NBC’s “Meet the Press.”

Federal officials paused the J&J vaccine for more than a week as they investigated over a dozen blood-clotting incidents among 7 million recipients of the single-shot vaccine. The clots tended to impact women under 50.

Advisers to the Centers for Disease Control and Prevention voted Friday to continue the vaccine’s use with a fact sheet for doctors and recipients, prompting criticism from some doctors who wondered why it didn’t include an explicit warning for women of certain ages since alternatives exist.

Dr. Collins said the Advisory Committee of Immunization Practices met for a full day before deciding to make the J&J version available to everyone again.

“I think that was the right decision,” he said. “When you consider the nature of this risk, this is truly a rare event.”

The J&J vaccine was approved much later than messenger-RNA vaccines from Pfizer-BioNTech and Moderna and accounts for less than 5% of the 225 million shots delivered in the U.S. so far.

However, it is viewed as a versatile tool because it is easy to store and requires one dose instead of two, making it ideal for governments trying to reach transient or homebound populations or people who don’t want to schedule two vaccine appointments.

New York, Virginia, Michigan and other states announced an immediate restart after the FDA and CDC cleared the vaccine late Friday. For instance, the shots were deployed over the weekend at a mass-vaccination site at the Indianapolis Motor Speedway.

Its reintroduction comes at a critical phase in the vaccine effort. More than half of U.S. adults and 42% of the national population overall has received at least one dose of a COVID-19 vaccine, though governors say they’re seeing demand slow down.

That’s prompting fears the vaccination campaign will stall out before the U.S. reaches sufficient levels of immunity. It’s an elusive target, but experts say at least 70% of the population should be vaccinated to wrangle the virus.

“I’m worried. We have seen our vaccination go down about half of what it was three weeks ago,” Ohio Gov. Mike DeWine told CBS’s “Face the Nation.”

States have opened the shots to everyone 16 and older — not just priority groups — and officials are thinking about ways to be more targeted in their approach.

Mr. DeWine said his state is reaching out to businesses to help them get their workers vaccinated.

“We’ve got to be more aggressive,” Mr. DeWine said.

Dr. Collins said there are clear reasons to get vaccinated. For example, he and his wife recently had a dinner at his house with another couple who were fully vaccinated.

“If you’re not vaccinated, you’re missing out on that chance to lift that sort of blanket of fear that’s been there,” he told NBC. “Even if you don’t think COVID-19 is that big a deal, tell me whether you haven’t at some points worried about whether that’s going to hit you and your family. This is the way to put that fear behind us and to get back to normal life. That’s an incredible gift and you just have to unwrap that gift.”

Vaccinators had been relying on the Pfizer and Moderna vaccines during the J&J pause that began on April 13.

Investigators found that 15 out of nearly 8 million people who received the J&J vaccine were diagnosed with a rare blood clotting disorder possibly linked to the shots, according to a presentation shared during the advisory panel meeting.

Three of the affected persons died after developing the disorder known as thrombosis with thrombocytopenia syndrome, or TTS.

Seven remained hospitalized while five have been discharged, the advisory committee said. The risk of developing these blood clots appears to be the greatest in women ages 30 to 39.

J&J’s vaccine is similar but not identical to the AstraZeneca-Oxford vaccine in Europe, where regulators in many countries temporarily suspended its use amid blood clot concerns. Denmark has banned the use of AstraZeneca’s vaccine.

The AstraZeneca and J&J vaccines possibly could trigger an immune response involving blood platelets and coagulation systems in some people, officials theorize.

European regulators last week announced they would allow the use of the J&J vaccine to resume with a formal warning label attached.

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