The Food and Drug Administration turned heads this morning when it directed all 50 states to temporarily halt the use of Johnson & Johnson’s COVID-19 vaccine after six people contracted a rare blood clotting disorder. Now, states are racing to follow through on already scheduled appointments despite this major setback. Until the FDA resolves the issue, vaccination clinics around the country will have to make do with vaccines from Moderna and Pfizer.
Breaking Down the Blood Clotting Issue
The FDA says it decided to pause the rollout of the J&J vaccine out of “an abundance of caution”. The agency said six women in the U.S. ages 18 to 49 developed a rare blood clotting disorder after taking the drug; one of the women passed away and another remains in critical condition.
The FDA and CDC issued a joint statement earlier today, stating, “Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
The J&J vaccine has already been administered to 7 million people all over the country.
Experts say symptoms such as shortness of breath, chest pain, and fatigue, usually start between six and 13 days after vaccination.
Dr. Anne Schuchat, the principal deputy director of the CDC, added, “For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your healthcare provider and seek medical treatment.”
However, if you or someone you know got their J&J vaccine shot several weeks ago, you probably don’t need to worry.
As Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told reporters, “We know that for these vaccines, that for the first several days after vaccination, there are flu-like symptoms that can include headache,” but these are common side effects. “It would be more likely if someone presented to an emergency room with very severe headache or blood clots, that a history of vaccination be elicited,” so a plan of care can be put in place. He also said if the patient also has low platelets, the doctor should consider a possible correlation to the vaccine.
The CDC says it will convene an emergency meeting of the Advisory Committee on Immunization Practices on Wednesday to review the safety information.
The COVID-19 vaccine from AstraZeneca has come under fire for similar safety concerns after several people experienced blood clotting. The drug hasn’t been approved for emergency use in the US, but it has been administered widely across Europe. Both the AstraZeneca and J&J vaccines use a similar platform to inoculate patients. They contain an adenovirus, a common type of virus that typically causes mild cold symptoms.
Regulators in the EU recently announced that the drug is indeed safe, but an unusual blood clotting with low blood platelets would be added as a “very rare” side effect to the AstraZeneca vaccine’s product information, along with a slew of other possible adverse reactions.
When J&J submitted its safety data to FDA in February, the concerns over blood clotting never came up. It wasn’t detected in any of the adults that participated in the clinical trial. The FDA said at the time the most common side effects reported were headache and fatigue, followed by muscle aches, nausea and fever.
It’s unclear how long the delay will last, but representatives from the FDA said they hope to resolve the issue within a matter of days.
Can the U.S. Fill the Gap?
The news puts a wrench in Johnson & Johnson’s plan to deliver 100 million doses of its vaccine by the end of May.
However, the White House is staying positive. Vaccines from Pfizer and Moderna already account for around 95% of the shots administered this week, so, “This announcement will not have a significant impact on our vaccination plan,” said Jeff Zients, the White House Covid-19 response coordinator.
President Biden hoped to have enough shots for every adult American by the end of May, but that’s looking less likely after today.
With the J&J vaccine on pause, the country hopes to have enough vaccines to vaccinate 200 million people by the end of May and enough for another 100 million people by the end of July.
“This is more than enough supply to continue the current pace of vaccinations of 3 million shots per day, and meet the president’s goal of 200 million shots by his 100th day in office – and continue on to reach every adult who wants to be vaccinated,” Zients added.
Clinics across the country, especially those in the south and Midwest, say they are already running out of arms for vaccines. Some areas have an overabundance of vaccines, while coastal and more urban areas run low on supply. The J&J delay will likely fuel vaccine hesitancy among many Americans, but it’s important to remember that these side effects remain extremely rare.