Archived blog from CDC/FDA press conference Tuesday:
- Dr. Janet Woodcock, acting FDA commissioner: “These events appear to be extremely rare.”
- Dr. Peter Marks, Director, FDA Center for Biologics Evaluation and Research: Treatment for this particular type of blood clot is different than the treatment for other blood clots. It needs alternative treatments.
- Marks: Of the clots seen in the U.S., one case was fatal. One patient is in critical condition.
- Marks: The FDA will revise the fact sheets for recipients and health care providers.
- Marks: We take all reports of adverse reactions after vaccines very seriously.
- Dr. Anne Schuchat, principal deputy director of CDC: “I know the information will be very concerning to Americans who already received the Johnson and Johnson…vaccine.”
- Schuchat: The pause is meant “to prepare the health care system” to treat patients accordingly and to report the events they may see in recipients.
- Schuchat: For people who have gotten the vaccine a month ago, the risk is very low at this time. for those who got the vaccine in the last couple of weeks, they should be aware of any symptoms. (Those with abdominal pain, shortness of breath, etc., should contact their healthcare provider)
- Schuchat: The clotting symptoms are different than the mild flu-like symptoms many experience in the couple days following their vaccine.
- Schuchat: We are not seeing these clotting events…with the other two vaccines.
- Schuchat: Those with appointments with the other two vaccines should keep the appointments.
- Woodcock: The pause will likely be just a matter of days.
- Woodcock: The decision was a result of extensive work on this set of events.
- Marks: The real thing that is notable is not just the (clotting), “it’s their occurrence together that makes a pattern, and that pattern is very similar to what was seen in Europe with another vaccine. I think we have to take the time to make sure we understand this complication and we address it properly.”
- Schuchat: “When we saw this pattern and were aware that treatment needed to be individualized for this condition, it was of the utmost importance to us to get it out. The pandemic is quite severe…vaccinations are critical so we want to make sure we make some recommendations quickly.”
- Marks: Have usually occurred about a week after vaccination and not longer than three weeks with a median of about 9 days after vaccination.
(WJW/AP) — The Food and Drug Administration and the Centers for Disease Control are calling for a pause in the use of Johnson & Johnson’s COVID-19 vaccine after six women who received it in the U.S. developed blood clots.
According to a thread of tweets by the FDA, about seven million people in the United States have gotten the Johnson & Johnson vaccine.
Officials are reviewing data involving six cases of a rare and severe type of blood clot in individuals after receiving the vaccine. All six individuals were women, between the ages of 18 and 48. One of the women died.
“Right now, these adverse events appear to be extremely rare,” according to the FDA.
The CDC will meet Wednesday to further review the cases. The FDA will review that analysis.
“Until that process is complete, we are recommending this pause,” according to the FDA. “This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.”
U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot, and states and other providers are expected to follow. The other two authorized vaccines, from Moderna and Pfizer, are not affected by the pause.
They are recommending that people who were given the J&J vaccine who are experiencing severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after receiving the shot contact their health care provider.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
The J&J vaccine received emergency use authorization from the FDA in late February with great fanfare, with hopes that its single-dose and relatively simple storage requirements would speed vaccinations across the country. Yet the shot only makes up a small fraction of the doses administered in the U.S.
In a statement from the White House, Jeff Zients, COVID-19 response coordinator, said the announcement will not have a significant impact on the country’s vaccination plan.
“Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date. Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans. Over the last few weeks, we have made available more than 25 million doses of Pfizer and Moderna each week, and in fact this week we will make available 28 million doses of these vaccines. 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. We are working now with our state and federal partners to get anyone scheduled for a J&J vaccine quickly rescheduled for a Pfizer or Moderna vaccine.”
J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week the drugmaker took over the facility to scale up production in hopes of meeting its commitment to the U.S. government of providing about 100 million doses by the end of May.
Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the U.S. Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets, one that seems to occur more in younger people.
The European Medicines Agency stressed that the benefits of receiving the vaccine outweigh the risks for most people. But several countries have imposed limits on who can receive the vaccine; Britain recommended that people under 30 be offered alternatives.
But the J&J and AstraZeneca vaccines are made with the same technology. Leading COVID-19 vaccines train the body to recognize the spike protein that coats the outer surface of the coronavirus. But the J&J and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body. J&J uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
The announcement hit U.S. stock markets immediately, with Dow futures falling almost 200 points just over two hours before the opening bell. Shares of Johnson & Johnson dropped almost 3%
Georgia, Colorado and North Carolina have already halted the use of the Johnson & Johnson shot at some vaccination sites after reports of several adverse reactions.