Sources: United States Food and Drug Administration and United States Centers for Disease Control and Prevention (Information):
United States: Federal health agencies are recommending a pause on the use of Johnson & Johnson’s COVID-19 vaccine as they investigate blood clot reports.
In a joint statement on Tuesday, April 13th, 2021, the United States Food and Drug Administration and United States Centers for Disease Control and Prevention said that they were investigating unusual clots in six women that occurred 6 to 13 days after vaccination.
The clots occurred in veins that drain blood from the brain and occurred together with low platelets, and all six cases were in women between the ages of 18 and 48.
The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
United States federal distribution channels, including mass vaccination sites, will pause the use of the Johnson & Johnson’s COVID-19 vaccine shot, and states and other providers are expected to follow. The other two authorized vaccines, from Moderna and Pfizer, make up the vast share of COVID-19 shots administered in the United States and are not affected by the pause.
United States Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the United States Food and Drug Administration has also launched an investigation into the cause of the clots and low platelet counts.
“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Anne Schuchat, principal deputy director of the United States Centers for Disease Control and Prevention, and Dr. Peter Marks, director of the United States Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a joint statement.
They are recommending that people who were given the Johnson & Johnson’s COVID-19 vaccine shots 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.
United State health authorities cautioned doctors against using a typical clot treatment, the blood-thinner heparin.
“In this setting, administration of heparin may be dangerous and alternative treatments need to be given,” said United States Food and Drug Administration and the United States Centers for Disease Control and Prevention.
European authorities are investigating the AstraZeneca cases have concluded clots appear to be similar to a very rare abnormal immune response that sometimes strikes people treated with heparin, leading to a temporary clotting disorder.
Officials say they also want to educate vaccine providers and health professionals about the “unique treatment” required for this type of clot.
Johnson & Johnson said it was aware of the reports of “thromboembolic events,” or blood clots, but that no link to its vaccine had been established.
In a statement, Johnson & Johnson said, “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”
The Johnson & Johnson 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. as J&J has been plagued by production delays and manufacturing errors at the Baltimore plant of a contractor.
Last week, Johnson & Johnson took over the facility to scale up production in hopes of meeting its commitment to the United States government of providing about 100 million doses by the end of May 2021.
According to data from the United States Centers for Disease Control and Prevention, only about 9 million of the Johnson & Johnson’s doses have been delivered to states and are awaiting administration,
Until now concern about the unusual blood clots has centered on the vaccine from AstraZeneca, which has not yet received authorization in the United States, but 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.
Johnson & Johnson and AstraZeneca COVID-19 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 Johnson & Johnson and AstraZeneca vaccines use a cold virus, called an adenovirus, to carry the spike gene into the body.
Johnson & Johnson uses a human adenovirus to create its vaccine while AstraZeneca uses a chimpanzee version.
Following the announcement Tuesday morning, health officials in California, including in Los Angeles, California as well as in Riverside County, California and San Bernardino County, California, announced that they will “pause” the use of the Johnson & Johnson vaccine until further notice.
In a press release, the County of San Bernardino spoke about this morning temporarily paused distribution and use of the Johnson & Johnson COVID-19 vaccine in accordance with recommendations made by state and federal health agencies.
“None of the six cases were in California,” said the County of San Bernardino in their press release adding, “More than 6.8 million doses of the Johnson & Johnson/Janssen vaccine have been administered in the U.S.”
San Bernardino County Health Officer Dr. Michael A. Sequeira said, “The county has no higher priority than the health and safety of our residents. Although this condition is extremely rare among Johnson & Johnson recipients – much more rare than serious blood clots among those who contract COVID-19 – this pause is prudent pending further federal review. The Pfizer and Moderna vaccines remain widely available in our county and have proven to be safe and effective. The public should remain confident in the nation’s COVID-19 vaccination effort.”
San Bernardino County Health Officer Dr. Michael A. Sequeira said that anyone who has received the Johnson & Johnson/Janssen vaccine and who develops a severe headache, abdominal pain, leg pain or shortness of breath should contact their health care provider.
According to the County of San Bernardino, the Johnson & Johnson vaccine accounts for 48,600, or 6.6%, of the 738,225 vaccine doses received countywide well Pfizer accounts for 49.5% and Moderna 43.9%.
Stay tuned to ZachNews as more information continues to come in.