CDC and FDA Pause Use of Johnson & Johnson Vaccine After It Causes Rare Blood Clotting In Six Women

This morning, federal officials recommended that states avoid using Johnson & Johnson’s Covid-19 vaccine until an investigation into six unusual, but severe clotting problems in women who received the vaccine is conducted.

The clotting problem is similar to one that has been identified following the use of AstraZeneca’s Covid-19 vaccine, which has yet to be approved for use in the United States. It’s also related to an incident that happened during a Johnson & Johnson clinical trial in the US, which caused the trial to be temporarily suspended.

The CDC and FDA both issued the recommendation, which is not a restriction against using the vaccine. On Wednesday, the CDC’s Advisory Committee on Immunization Practices will be held to review the data.

“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the statement said. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”

Six cases of a rare form of blood clot known as a cerebral venous sinus thrombosis (CVST) were identified, all of which were associated with low blood platelet levels, a disorder known as thrombocytopenia. The symptoms appeared between six and thirteen days after vaccination in women aged 18 to 48.

More than 6.8 million doses of the Johnson and Johnson vaccine had been distributed in the US as of Monday.

The occurrences appeared to be “extremely rare,” according to the agencies’ statement. It didn’t mention the background rate for such incidents or how many cases you’d expect to see in non-vaccinated people. This figure is required to help authorities determine whether an adverse reaction to vaccination was caused by the vaccine or was simply a coincidence.

CVST incidents occur at a rate of around five per million people per year, according to the Johns Hopkins School of Medicine.

People who have received the Johnson & Johnson vaccine and develop any symptoms within three weeks of receiving it should contact their health care provider.  According to the CDC and FDA, some of the symptoms are extreme headache, stomach pain, leg pain, or shortness of breath.

The Johnson & Johnson vaccine investigation arrives at a crucial time for the Covid-19 vaccine rollout. Vaccine stocks, which were low earlier this year, are beginning to replenish; instead of long lines, some jurisdictions report unclaimed shots.

This was to be predicted; it was previously understood that among the hordes of people desperate to be vaccinated were those who were concerned about receiving recently founded vaccinations, as well as those who would reject vaccines under any circumstances. The challenge would be persuading the former to get vaccinated in the face of news of a possible association between certain Covid vaccines and a serious side effect.

Despite this, vaccination with the AstraZeneca vaccine continues in several nations, but some have put restrictions on who may obtain it, reserving it for older adults who have not experienced these side effects.