“Less than 1 in a million,” Dr. Anthony Fauci noted during a White House briefing on Tuesday.
All six cases were in women aged 18 to 48, the agencies said in a statement, and symptoms appeared six to 13 days after vaccination. The recommendation to take a break is the result of “great caution”, they added, and these cases “seem extremely rare”.
“It makes sense now to take a break, to find out if this is a real phenomenon, if it is really associated with the vaccine and who, in particular, could be most at risk”, Dr Jonathan Reiner, professor of medicine and surgery at George Washington University, told CNN on Tuesday.
“The way I want people to think about it is this: These vaccines are incredibly effective. You are much more likely to die from the coronavirus than you are to have a significant complication from these vaccines, ”he said.
The J&J news comes amid a major race in the United States: Officials strive to get as many Covid-19 shots in the arms as possible to defeat another possible Covid-19 outbreak then that variants of the virus are rampant and that cases and hospitalizations of Covid-19 are gradually upwards, mainly in the younger groups who have not yet been vaccinated.
The break should “underscore and confirm how seriously we take safety, even though it’s a very rare event,” Fauci told CNN on Wednesday. Fauci had no reason to believe there were many more cases, but the break will allow officials to take a peek to see, he said.
“If anyone has any doubts that maybe they don’t take safety very seriously, I think it’s a statement that safety is a primary consideration when it comes to the FDA and of the CDC, ”he said. “That’s why it was done and that’s why it’s a hiatus. It is not a cancellation; it’s a break. ”
“Our confidence in these vaccines is still high”
The recommendation to take a break should show “how seriously we take adverse events and how much of a top priority safety really is,” US Surgeon General Dr Vivek Murthy told CNN Tuesday evening.
There are several reasons for the break, Murthy said.
“The first is to investigate quickly, to understand if there is a link between the vaccine and the adverse events. But there is also another reason to take a break, which is to give ourselves time to talk to the medical community … so that we can ask for their help in looking for the kind of symptoms that might be of concern to us. “
And a break is not unusual, he added. The breaks happen “often,” Murthy said, with vaccines or new drugs, “to assess new developments. “
“Our confidence in these vaccines is always high… We just want to make sure that the investigations are fully completed,” he said.
The fact that blood clot issues were not raised during Johnson & Johnson vaccine trials comes down to a “question of numbers,” Fauci said in an interview with NBC on Tuesday.
“Typically, clinical trials are between 30,000 and 40,000 people,” he said. “You are talking about an adverse event that has occurred in six out of 6.85 million people who are vaccinated in the United States with J&J. “
“When you step into the real world, you give it to tens and tens of millions of people, and that’s when you see if there’s a rare adverse event,” Fauci added.
The break could have a significant impact on students
Even with the break on the J&J vaccine, the United States has enough Moderna and Pfizer vaccines to be able to vaccinate its adult population by the end of July, Murthy told CNN.
“I am confident that even with what is happening with Johnson & Johnson, we will be able to vaccinate the country and do it effectively,” he said.
In Kentucky, Gov. Andy Beshear said that while the break wasn’t good news, it wasn’t crippling for the state’s vaccination efforts either.
State leaders from other states, including New York and North Carolina, have also said they will be able to continue vaccinations with their Pfizer and Moderna supplies. In Ohio, state officials said on Tuesday that the majority of doses of J&J the state had received were directed to mass vaccination clinics, colleges and universities, “most of which have already completed. their student vaccinations ”.
Most mass immunization clinics and university clinics that planned to offer this vaccine this week will offer Pfizer or Moderna vaccines instead.
“A total of eight sites will not offer any vaccines this week as the healthcare community works to recognize, report and manage any adverse events related to the Johnson and Johnson vaccine,” said Ohio Gov. Mike DeWine’s office. .
Across the country, the discontinuation of the J&J vaccine could have a significant impact on students, who were key targets for shooting before leaving school at the end of the spring semester.
“There isn’t enough time to give it a second before many students leave for the summer,” according to an Ohio state official. “This is a much bigger deal than the White House will recognize. “
An official in another Midwestern state said college campuses have scheduled vaccination clinics for students during the last two weeks of April. The break on J&J vaccines makes those plans very uncertain, the official said, depending on the length of the hiatus.
Good news from other vaccines
The other two Covid-19 vaccines approved for the United States – Pfizer and Moderna – are not involved in the hiatus, Murthy added on Tuesday.
That means the company will deliver 220 million doses by the end of next month, 20 million more than expected. The company previously expected to fulfill its US contract of 300 million doses by the end of July – and that deadline would also come two weeks earlier, Bourla said.
The United States also purchased 300 million doses from Moderna, which the company says remains on track to complete delivery by the end of July.
Moderna also announced that its vaccine remained over 90% effective for at least six months, citing preliminary results from its Phase 3 trial.
The ongoing Phase 3 clinical trial of the Pfizer / BioNTech vaccine also confirms that its protection remains high for at least six months after the second dose, the companies said earlier this month.
CNN’s Elizabeth Cohen, Michael Nedelman, Jeff Zeleny, Chris Boyette, Alec Snyder and Lauren Mascaren contributed to this report.