Amid blood clot concerns, US to resume use of Johnson & Johnson's single-dose COVID-19 vaccine
New Delhi | Jagran News Desk: Amid blood clot concerns over the vaccine, the US Food and Drug Administration (USFDA) and Centre for Disease Control and Prevention (CDC) on Friday (local time) lifted the ban on the use of Johnson & Johnson's vaccine against the COVID-19 in the US and resumed the use of the single-dose vaccine in the country.
The announcement by the Food and Drug Administration and the Centers for Disease Control and Prevention, came after an advisory committee to the CDC recommended the United States to resume use of the vaccine without any restrictions on who should be offered it, CDC said in a statement.
The pause was recommended after reports of six cases of a rare and severe type of blood clot in individuals following administration of the Janssen COVID-19 Vaccine. The government uncovered 15 vaccine recipients who developed a highly unusual kind of blood clot, out of nearly 8 million people given the J&J shot. All were women, most under age 50. Three died, and seven remain hospitalized.
But ultimately Friday, the Food and Drug Administration and Centers for Disease Control and Prevention decided that J&J's one-and-done vaccine is critical to fighting the pandemic — and that the small clot risk could be handled with warnings to help younger women decide if they should use that shot or an alternative.
"Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work--identifying even these small number of cases. We've lifted the pause based on the FDA and CDC's review of all available data and in consultation with medical experts and based on recommendations from the CDC's Advisory Committee on Immunization Practices," said Janet Woodcock, M.D., Acting FDA Commissioner.
The US decision — similar to how European regulators are rolling out J&J's shot — comes after CDC advisers earlier Friday voted 10-4 to resume vaccinations but panelists made clear that they must come with warnings about the risk. The group debated but ultimately steered clear of outright age restrictions.
"We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider," said Woodcock.
European regulators earlier this week made a similar decision, deciding the clot risk was small enough to allow the rollout of J&J's shot. But how Americans ultimately handle J&J's vaccine will influence other countries that don't have as much access to other vaccination options.
(With Agencies Inputs)
Posted By: Talibuddin Khan