U.S. health officials on Friday lifted a recommended hiatus for the use of Johnson & Johnson’s Covid-19 vaccine and provided assistance to state and local authorities in distributing the doses that are considered critical to delivering life-saving shots to hard-to-reach ones To bring communities.
The Centers for Disease Control and Prevention and Food and Drug Administration’s announcement came after the CDC’s Advisory Committee on Immunization Practices known as ACIP, recommended on Friday for further use of the J&J vaccine, explored the benefits of the Shot outweighed risk. The committee is an external body of experts that advises the CDC.
Advisory panel members did not recommend U.S. regulators limit the use of the J&J vaccine by age or gender, but suggested that the Food and Drug Administration consider adding a warning to women under the age of 50.
In a statement late Friday, the FDA and CDC said they were confident the vaccine would be safe and effective in preventing Covid-19, adding that the risk of blood clots was “very low”.
“Safety is our top priority,” said Acting FDA Commissioner Dr. Janet Woodcock in a statement. “This pause was an example of our comprehensive security monitoring designed to work – and identify even this small number of cases.”
“We have taken the hiatus based on a review of all available data by the FDA and CDC and in consultation with medical experts and based on recommendations from the CDC Advisory Committee on Immunization Practices,” said Woodcock. “We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh the known and potential risks in those aged 18 and over.”
During a press conference on the announcement, Woodcock said health care providers should review revised FDA datasheets on the vaccine, which include details about rare blood clots. People with questions about the vaccine should discuss these with a health care provider, she said.
J & J’s Covid-19 vaccine, like the Pfizer and Moderna shots, received emergency approval from the FDA to begin distributing the doses in the United States. An EEA grants conditional clearance based on two months of safety data until another submission for full approval, which normally requires at least six months of data.
On April 13, the FDA and CDC urged states to temporarily discontinue use of J & J’s vaccine “out of caution” after it was reported that six women aged 18 to 48 years had a cerebral combination with low platelets Venous sinus thrombosis developed. CVST occurs when a blood clot forms in the venous sinuses of the brain. It can prevent blood from draining from the brain and can eventually lead to bleeding and other brain damage.
Within hours of the warning from U.S. regulators, more than a dozen states, along with some national pharmacies, stopped vaccinating with J & J’s vaccine. Some sites replaced the J&J recordings for scheduled appointments with either the Pfizer or Moderna vaccine.
The US government should lift the recommended hiatus shortly after the committee voted in favor.
Prior to Friday’s vote, the committee debated whether to recommend against J & J’s use of the vaccine or recommend it to U.S. regulators enforcing a warning label. The committee also considered limiting use of the vaccine based on age or other risk factors.
During the meeting, CDC official Dr. Tom Shimabukuro, there have been no reports of the condition of those who received the Pfizer BioNTech mRNA vaccine. There have been three reports of CVST in patients receiving the Moderna vaccine, he said, even though the patients did not have the low platelet levels seen in the J&J recipients.
Platelets help the body form blood clots to heal wounds. US health officials warned against a treatment such as blood-thinning heparin in patients with low platelets, which could make their condition worse.
Rare blood clots with low platelets occur in women aged 18 to 49 at the rate of 7 per 1 million vaccinations for the J&J shot and 0.9 per 1 million in women aged 50 and over. This is evident from a slide presented at the CDC panel meeting. CDC has confirmed a total of 15 cases of rare blood clots, including 12 women who developed blood clots in the brain. According to the presentation, three women died and seven remained in the hospital.
There are no confirmed cases in men, although officials have stated that they are looking at potential additional cases.
Dr. Michael Streiff, a hematologist at Johns Hopkins University Medical School, said the condition is very rare under normal circumstances. “I can tell you from my experience treating these patients that I’ve just never seen it before,” he told the committee during a presentation on Friday.
Earlier this week, J&J announced that it would restart its vaccine rollout in Europe after regulators there backed the single vaccine by recommending adding a warning to the label. The European Medicines Agency has examined all available evidence, including reports from the United States.