After six women developed a rare and severe form of blood clotting in six years who received Johnson Johnson's Covid-19 vaccine, U.S. health officials called for an immediate pause in using the single dose.
The decision comes at a crucial juncture in the US vaccination effort that has gained speed in recent weeks at the same time a worsening outbreak driven by coronavirus variants grips the upper Midwest. And it is likely to heighten worry over vaccines around the world after similar issues caused delays in the distribution of AstraZeneca Plc's shot.
A type of blood clot in the brain called benign sinus thrombosis was seen in the women with low levels of blood platelets, all between the ages of 18 and 48, federal health officials said Tuesday in a statement. One of the cases was critical and a second is in fatal condition, Peter Marks, director of the Center for Biologics Evaluation and Research of the Food and Drug Administration said in a Tuesday briefing.
More than 6.8 million doses of the single-shot J& J vaccine have been administered in the U.S. through Monday. Those who received vaccination a month ago are at low risk of the complication, but people who got it in the last few weeks should be on the lookout for headache, leg pain, abdominal pain and shortness of breath, said Anne Schuchat, chief deputy director at the Centers for Disease Control and Prevention.
According to Marks, there has been no definitive cause of the disorder but did not declare blood clotting incidents related to the AstraZeneca Plc vaccine. After vaccination, it may be attributed to an immune response that leads to activation of platelets and clotting, said he.
Schuchat, meanwhile, emphasized that the clotting events with low platelet counts are not being seen with the moderna Inc. BioNTech SE vaccine and the Pfizer Inc. shot.
We recommend a pause in the use of this vaccine out of an abundance of caution, said the CDC and FDA in a joint statement Tuesday. This is in part important to ensure that the health care provider community is aware of the potential for these unique events and can plan for proper recognition and management due to the appropriate treatment required with this type of blood clot.
A key reason for the pause, FDA officials said in the briefing, is that the rare constellation of symptoms means that the normal treatment for blood clots, the blood-thinner heparin, could make the problem worse or even kill a patient who has the abnormal adverse reaction.
In a statement, J& J said that it has decided to delay the rollout of its vaccine in Europe. Walgreens Boots Alliance Inc. and CVS Health Corp. who have been dispensed with the shot in drugstores, each said they would immediately pause. New York- Shares fell to USD$ 157,39 at 10:56 a.m. in J& J trading.
The Biden administration has been trying to accelerate vaccinations in recent weeks as new coronavirus variants increase the risk that the pandemic could drag on. During the White House Covid 19 response coordinator Jeff Zients said that the pause will not have a significant impact on our vaccination plan.
We expect it to be a matter of days for this pause, Janet Woodcock said at the Tuesday briefing on FDA.
The decision could broaden the hesitancy of vaccines, which is seen as a significant obstacle for health policy makers as they try to increase immunizations. The J& J shot has been popular due to its single dose- vaccines, made by Pfizer Inc.- BioNTech SE and Moderna Inc.- two doses that are spaced several weeks apart.
Many of the J& J doses in the U.S. have been targeted by the federal government through the distribution program targeting pharmacies, federally qualified health centers and other locations to harder-to-reach populations.
The CDC will hold a Tuesday meeting of its Advisory Committee on Immunization Practices to assess cases and review their potential significance. According to the statement, the FDA will also investigate the CDC assessment as it reviews these cases.
The recommended pause may also complicate the global vaccination push, coming just weeks after a vaccine that developed on a similar approach and has raised similar concerns in Europe by AstraZeneca and the University of Oxford. Clotting fears have prompted many countries to impose age restrictions on use of the Astra vaccine which was developed together with the University of Oxford.
J& J has recently begun shipping to the European Union; the drug regulator of the European Medicines Agency did n't immediately respond to a request for comment. The EMA announced Friday that it is assessing blood clots in people who received the J& J vaccine, after four fatal cases of unusual clots accompanied by low blood platelets, one of which was fatal.
On Friday afternoon, FDA spokesperson Abby Capobianco said in an emailed statement that the agency had not found a causal relationship between the J& J vaccine and the six cases of thromboembolic events and was continuing its assessment of the cases.
Her analysis of the data will inform the potential need for regulatory action, she said.
The agency shared information with the EMA, which became the basis of the EU probe, she said. Asked Monday if further analysis had determined a causal relationship, the FDA declined to comment.
A handful of vaccination sites in North Carolina, Colorado and Georgia temporarily stopped administering the J& J vaccine last week in the wake of adverse reactions, including nausea and fainting.
Such side effects are typical of vaccination, health authorities said at the time. An analysis by the North Carolina Department of Health and Human Services did not find any safety issues or cause for concern Friday, the CDC said in a statement.
The CDC recommends continuing to administer the vaccine. On the same day, J& J said in a statement that it was collecting information, assessing adverse events and sharing reports with the FDA and other health agencies.
The company said that there is no greater priority than the safety and well-being of the people we serve, if we say so.
This is part of the comprehensive process to inform health authorities' comprehensive surveillance programs that monitor the overall safety of medicines as well as the vaccines authorized for use against this pandemic. For more articles like this, please visit bloomberg.com at www.flowerberg.com.
Subscribe now to stay ahead with the most trusted business news source in the world.