On Friday, the top health regulators said that the United States can resume the usage of the Johnson & Johnson’s COVID-19 vaccine immediately, ending a 10-day pause to enquire the vaccine’s link to extremely rare but potentially deadly blood clots.
The U.S. Centers for Disease Control and Prevention, and the U.S. Food and Drug Administration said in a joint statement that the health systems and the vaccine recipients would be warned of the risk involved with a potentially fatal syndrome that involves severe blood clots and also low platelets.
The agencies state the decision following a meeting held by the outside advisers to the CDC that thereby recommended the vaccine pause to be ended. The decision was however followed by investigations by the agencies into the risks attached to the vaccine.
CDC Director Rochelle Walensky stated that they are no longer recommending a pause in the usage of the vaccine and added that the vaccine could be used immediately.
It was earlier on Friday when the CDC panel voted 10-4 that the J& J COVID-19 vaccine is now recommended for use in people above 18 years of age based on the parameters of its current FDA authorization.
Dr. Beth Bell, a member of the advisory panel and also a clinical professor at the University of Washington in Seattle said that the benefits do outweigh the risk from a population and individual perspective.
Furthermore, the J&J’s Chief Scientific Officer, Paul Stoffels said in a statement that the Committee’s recommendation is an essential step towards continuing the urgently needed vaccinations in a safe method for millions of people in the U.S.
The J& J executives said that the FDA shall update the emergency use authorization for the vaccine to include details about the risk and also on how to recognize, and treat the condition.
William Moss, who is the executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said that the vaccine should be used with warnings of the risk as it shall then help advance the vaccination effort.
Moss said in an email that giving people the choice to receive a single-dose vaccine shall help them get more people vaccinated faster and it shall also better protect some populations, especially those who are homeless or incarcerated.
On Tuesday, the European Medicines Agency said that the benefits of the shots have outweighed its risk factors and is now recommended added by a warning about the unusual blood clots with low blood platelet counts to the vaccine’s product label. The J&J has resumed its rollout.
Moreover, the regulator has said that the blood clots in patients who have received the J&J Vaccine bear close resemblance to 169 cases in Europe who have been reported with the AstraZeneca Plc vaccine.
J&J has faced several setbacks but now the FDA inspectors have imposed a long list of cleanliness and safety issues at the BioSolutions plants making the J&J vaccine.