Early Tuesday morning, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) released a statement suggesting states stop administering Johnson & Johnson’s single-dose coronavirus vaccine.
With nearly 7 million doses of the vaccine already administered nationwide, the announcement prompted swift concern from officials and their constituents alike.
The CDC and FDA held a conference early Tuesday in an attempt to answer some of these questions; Jeff Zients, White House COVID-19 response coordinator, and Dr. Anthony Fauci, the nation’s leading infectious disease expert, joined Tuesday’s White House press briefing to do the same.
Officials and experts largely shared two messages with the American public; one, that the pause is not immediate cause for panic, and two, that the vast majority of Americans can — and should — get vaccinated with either a Pfizer or Moderna shot by the summer.
Here are answers to questions you may have:
The CDC and FDA are investigating reports of a rare but potentially dangerous blood clot found in only six women who received the Johnson & Johnson vaccine nationwide. Until the investigation is finalized, the agencies are recommending that states pause using Johnson & Johnson's COVID-19 vaccine.
Over 6.8 million doses of the single-shot regimen have been administered across the country; the vast majority of people who have taken the shot have experienced no major side effects.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets, the fragments in blood that normally form clots. All six cases were in women between the ages of 18 and 48. One person died, another is in critical condition; all of the cases remain under investigation.
The recommendation came out of an “abundance of caution,” the FDA and CDC said in a statement.
A CDC committee will meet Wednesday to discuss the cases, and the FDA has also launched an investigation into the cause of the clots and low platelet counts. The investigation is expected to last a matter of days.
The answer varies based on who you are, and when you got the shot.
Since the individuals who experienced blood clotting from the Johnson & Johnson vaccine were all women between the ages of 18-48, it’s less likely that men who received that particular shot will have similarly severe side effects.
If you got the J&J shot over a month ago, Dr. Fauci says the pause “really doesn’t mean anything” as far as the anticipated efficacy of the vaccine. Additionally, onset of the thrombotic phenomena in all of the affected individuals occurred between 6 and 13 days following vaccination, Fauci said — so if you got the vaccine a month ago and have yet to fall ill, you likely won’t.
People who got the Johnson & Johnson vaccine within the last two or three weeks “should look for any symptoms” of severe side effects, said Dr. Anne Schuchat, principal deputy director of the CDC.
These symptoms will be different than those typically associated with post-vaccination conditions, which the CDC warns can include fever and mild, flu-like conditions.
Signs of a more severe problem may include an intense headache, dizziness, abdominal pain, leg pain, or shortness of breath, Fauci said Tuesday. Should you experience these conditions, authorities advise to contact your medical provider immediately.
But Dr. Fauci also made sure to add, for those who recently got the vaccine, not to “have an anxiety reaction” should they develop similar symptoms, as the chances are currently less than one in a million.
This answer will also vary based on a number of factors — some of which will likely not be known until after the CDC committee finalizes its investigation.
Without making any predictions, Fauci said it would be “entirely conceivable” that upon review of those who experienced the severe thromboembolic side effects, the FDA and CDC may provide updated guidance on which demographics of people should — or should not — receive a Johnson & Johnson vaccine.
Until the committee’s recommendations are released, federally run mass vaccination sites will pause the use of the J&J shot. The federal government is “working with state and federal partners” to get anyone currently scheduled for a Johnson & Johnson vaccine switched over to an appointment for one from either Pfizer or Moderna, Zients said Tuesday.
Some states, like New York, have already begun the process of shifting away from Johnson & Johnson doses. Officials said Tuesday Pfizer doses will be given to those scheduled for the J&J jab in the coming days.
Other states, like New Jersey, are either cancelling or putting on hold all Johnson & Johnson appointments for the time being. Per a CNBC tally, over two dozen states have taken similar measures to New York and New Jersey since news of the CDC and FDA investigation broke earlier Tuesday.
Still, the announcement is not a mandate. Doctors and patients can still use J&J’s vaccine if they decide its benefits outweigh its risks for individual cases, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Visit the health department website or contact your local pharmacy to get more specific update guidance on how the pause impacts your state.
In short, yes.
According to the White House, the Johnson & Johnson pause "will not have a significant impact" on the country’s ability to vaccinate all Americans who want a jab by the end of May.
The administration plans to step up shipments of the Pfizer and Moderna vaccines to a combined 28 million this week, an increase from the past weekly rate of about 25 million. That increase will keep the country on pace with its daily vaccine administration average of 3 million per day.
Even without J&J’s vaccine, White House officials said they remain on track to have enough supplies to vaccinate most American adults by the summer. Moderna and Pfizer have separately pledged to ship nearly 300 million vaccine doses across the country by July.
“We believe there’s enough vaccine in the system — Moderna and Pfizer — for all Americans who want to get vaccinated by May 31 to do so,” Zients said Friday.
Hours after the White House press conference, Pfizer CEO Albert Bourla said the pharmaceutical company has “ramped up production” of its COVID-19 vaccine, promising news for those who may have to swap from a J&J jab.
The company is now on track to deliver “10% more doses to the US by the end of May than previously agreed,” a 20 million dose increase from the company’s originally promised 200 million doses by the end of the month.
Pfizer will also be able to “supply the full 300M agreed on for the end of July two weeks early,” Bourla wrote, adding: “In the fight against COVID-19, we’re in this together.”
The Associated Press contributed to this report.