Why is Johnson and Johnson vaccine on hold?

Why is Johnson and Johnson vaccine on hold?
Why is Johnson and Johnson vaccine on hold?

California abruptly halted distribution of Johnson & Johnson’s COVID-19 vaccine on Tuesday, after federal regulators recommended pausing use of the single-shot regimen because of a rare side effect that caused severe blood clots in a handful of cases.

But government officials, from Gov. Gavin Newsom to the Biden Administration, insisted the setback would not significantly limit vaccine supply or delay the loosening of pandemic restrictions.

California’s plan to open eligibility for vaccines to everyone 16 and older on Thursday remains “on track,” Newsom said at a bill signing event Tuesday, and several Bay Area counties have already taken that step.

“It will not materially impact our ability to fulfill our expectations and commitment to provide enough vaccine to fully vaccinate all those that seek to get vaccinated, so that we can begin to more fully open our economy by June 15th,” Newsom said.

State epidemiologist Dr. Erica Pan said Tuesday that California is following recommendations of the U.S. Centers for Disease Control and Prevention and U.S. Food and Drug Administration to “pause” use of the Johnson & Johnson vaccine “until we receive further direction from health and safety experts.” Counties across the Bay Area said they are doing the same.

The CDC and FDA are investigating six reported cases of a “rare and severe type of blood clot” among more than 6.8 million people nationwide who received the Johnson & Johnson shot, the agencies said in a joint statement Tuesday morning. The cases involved women between the ages of 18 and 48 whose symptoms occurred six to 13 days after vaccination, one of whom has died.

While health and government officials emphasized the rarity of the reported severe side-effect, the news was unsettling for Bay Area residents who had booked appointments for the Johnson & Johnson shot.

“I feel that it’s a good call for them to hit pause on the J&J vaccine,” said Amie Lu, 24, of San Jose, who rescheduled her appointment.

Newsom said 8,800 people with appointments to receive Johnson & Johnson shots in the state’s MyTurn system were being switched to Moderna or Pfizer appointments.

Dr. Donna White Carey, a physician and executive pastor of True Vine Ministries in West Oakland, said she had fielded two-dozen calls by Tuesday afternoon from congregants and others who had received Johnson & Johnson shots when the church hosted a four-week vaccination clinic earlier this spring. More than 7,000 people were vaccinated at the clinic, which wrapped up earlier this month.

“I try to reassure people, and then of course let them know what to look for,” White Carey said.

The risk of an adverse reaction for people who received Johnson & Johnson vaccine more than a month ago is extremely low, according to the CDC. People who got a shot more recently should contact a healthcare provider immediately if they develop symptoms such as severe headaches, severe abdominal pain, severe leg pain or shortness of breath – these symptoms are different than the usual, minor reactions that some people may experience in the day or two following their vaccination.

Because the Johnson & Johnson vaccine does not need special refrigeration or a second dose, like the Pfizer and Moderna vaccines, it was seen as a key component in the nation’s effort to quickly immunize the population against COVID-19 before new virus variants render vaccines less effective.

But the J&J shots so far have made up a small share of the vaccine supply: They represent just 3.7% of doses administered nationwide, according to the CDC, and 7.2% of doses the federal government has delivered to California. Pan said J&J represented “less than 4% of the state’s allocation this week.”

Although most Bay Area counties said J&J represented a small sample of overall doses administered, the suspension was causing some problems. San Mateo County Supervisor said they are scrambling to find enough Moderna and Pfizer vaccines to supply an East Palo Alto clinic that had been using the J&J shots.

The White House said the U.S. has secured enough doses from Pfizer and Moderna to vaccinate 300 million Americans, and it expected to make available 28 million doses this week, which is “more than enough supply to continue the current pace of vaccinations of 3 million shots per day.”

In California, Thursday’s statewide expansion of vaccine eligibility for everyone 16 and up will add some 16 million people to the vaccine queue. There are almost 32 million residents in that category, but more than 15 million have already received at least one dose. At California’s current vaccination pace, it would take about a month and a half to give a shot to all 16 million people, but that does not account for people needing second shots.

Whether the stoppage will significantly affect that pace, which now averages more than 360,000 shots per day, will depend on how long it takes the federal government to evaluate any risks posed by Johnson & Johnson, said William Padula, a USC professor of pharmaceutical and health economics.

“The FDA is not hitting a stop button — it’s hitting a pause button right now,” he said.

If adverse reactions turn out to be more common and the FDA goes so far as to make the stoppage permanent, Padula said, it could take longer for vaccines to be widely available because two manufacturers, rather than three, would be providing the supply.

But if further study shows serious side-effects are extremely rare, Padula said, “I would expect that we’ll hear in the next several days or weeks from the FDA that this is a pause button that we can hit play on again.”

It was unclear Tuesday how long the shots will be shelved, but Bay Area residents looking for vaccines or helping others get immunized through social media weren’t concerned about availability.

“If you’re flexible on either schedule or distance, appointments are easy to come by if you know where to look,” said Clay Volino, 21, of Palo Alto, a Georgetown University student taking online courses from home who has helped more than 150 family and friends get shots.

Even so, there were concerns that worries about the J&J shot will slow the vaccination effort by making people more hesitant to get immunized.
“When there’s an adverse event with one vaccine, that causes people to question the safety of all the vaccines,” said White Carey, the Oakland physician and pastor. “This is a potential setback.”

“But as we get more information about this event and the investigation continues,” White Carey added, she hopes “we will be able to allay some people’s fears — and once again talk about the safety of the vaccine.”

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