First it was the manufacturing mess up that made Johnson & Johnson discard 15 million doses of its COVID-19 vaccine after it was accidentally contaminated and now the medical corporation is facing a pause for at least another week by the FDA and CDC in its rollout of its vaccine due to a rare side effect that causes blood clots.
Out of approximately seven million doses that have already been administered to Americans, so far there have only been seven reported cases—as of publication—of recipients experiencing blood clots that appeared between six to 13 days after being vaccinated.
Last Wednesday, the Advisory Committee on Immunization Practices (ACIP) met to discuss whether there was enough information to make age or risk factor-based recommendations regarding the vaccine, and what recommendation the committee felt is appropriate given currently available information for use of the vaccine.
During the ACIP meeting, an additional incident involving a 25-year-old man who developed blood clots, which occurred during a clinical trial, was reported, but could not currently be linked to the vaccine.
Since there has only been seven reported cases, the chances of having a complication from the Johnson & Johnson vaccine is just one in a million—an incredibly low number. All seven cases have occurred in women between the ages of 18 and 48, which has seen one death. The CDC will meet this Friday to provide recommendations on how to proceed with the J&J vaccine.
“The safety and well-being of the people who use our products is our number one priority,” Johnson & Johnson said in a statement on its website. “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine…Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our vaccine.”
The company has also been reviewing these cases with European health authorities and have decided to delay the rollout of its vaccine.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company added. “The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot. The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.”
So how does this pause of the one-dose vaccine hamper the county’s rollout plan?
“Today’s news of CDC and FDA recommendation of halting or pausing of the Johnson & Johnson vaccine is a setback,” Nassau County Executive Laura Curran admitted during a press conference held last Tuesday. “Our number one priority is the health and safety of our residents. While the blood clots that we’ve been reading about is rare…because the CDC and FDA recommended we pause the use of J&J, we are going to do that at all of our county run facilities until further notice.”
Curran urged residents that the county’s vaccination program is still robust and that 45 percent of county residents have already received at least one shot of a vaccine.
“Most of our progress in the county has been done with a very small percentage of Johnson & Johnson,” Curran said. “We have had incredible success with the Pfizer and Moderna vaccines. Since this news broke, my administration has been working to reevaluate our county run operations so we can continue to keep up with our record pace.”
Appointments for the Johnson & Johnson vaccine were recently scheduled at the Nassau Veterans Memorial Coliseum. In a last minute switch, Northwell replaced the vaccine with Moderna in order to avoid any appointment cancellations. Curran said that the county was relying on the Johnson & Johnson vaccine for its homebound seniors and inmate population.
“If any residents have questions or concerns and have received the Johnson & Johnson vaccine, you can call our county hotline at 516-227-9570,” Curran added. “If you have received a Johnson & Johnson vaccine, you’re still protected against COVID-19.
Also on hand at the conference was County Health Commissioner Dr. Lawrence Eisenstein who added that this situation should bring comfort to people because it shows that there are protections in place when new vaccines are introduced to the public.
“Every reportable possible outcome is required to be reported to the federal government,” he said. “It may end up being that this pause is temporary and in a few days or in a week or two, Johnson & Johnson is safely in play.”
The White House also weighed in.
“[This pause] allows the FDA and CDC to further investigate these cases to try and understand some of the mechanisms of what it is, some details about the history of the individuals who were involved that might shed some light on what will happen and what we will do,” Dr. Anthony Fauci said. “[It’s also important] to make physicians aware of this…rare syndrome.”
Fauci addressed the issue of vaccine hesitancy that may now be increased among people because of the pause.
“There have been 120 million people that have received at least one dose of a vaccine,” Fauci said. “Most of that is the mRNA from Pfizer and Moderna. There have been no red flags from those. You’re talking about tens and tens of millions of people with vaccine with no adverse effect. This is really rare. This is something that’s out of abundance of caution to give us time to look at it and see if we can get further information.”
