While many of the committee members – including public health experts, scientists and doctors – said they needed more information before making a call, others expressed their frustration over the damage that sustained uncertainty to the public would inspire confidence and vaccination efforts among the underprivileged population.
“We’re in a position where making a decision is not the same as making a decision,” said Nirav Shah, who is the director of the Maine Public Health Agency and the Association of State Officials and representing territorial health.
The panel does not yet know when it will meet again, but leaders said it could take more than a week to convene a new session. Top officials in Biden’s government administration said Monday that the J&J vaccine break could last days to weeks. It is not clear whether the CDC panel’s delay in making recommendations will drag out the federal government’s timeline for deciding how to proceed with the vaccine.
The CDC and FDA on Tuesday recommended stopping the use of millions of doses of J&J while investigating possible links between the six confirmed cases of blood clots and the vaccine. Officials stressed that these blood clots are partly of concern because the typical treatment for clotting – the blood thinner heparin – can make it worse.
All the known cases have in women aged 18-48 years. One of the women is dead, and another in a serious condition. But CDC officials said it could be difficult to enforce sex-based restrictions rather than age restrictions. Several European countries have used the approach for a similar vaccine made by AstraZeneca that is also associated with clotting problems.
The CDC panel, known as the Immunization Practices Advisory Committee, not only examines the six cases of blood clots among J&J recipients, but also discusses whether the risk of using the shot outweighs the benefit.
The J&J vaccine is easy to administer because it requires only one dose and can be stored in a refrigerator. However, CDC officials noted that the country has adequate supplies of safe and effective vaccines from Pfizer and Moderna. These shots use mRNA technology, while the vaccines from Johnson & Johnson and AstraZeneca are based on adenoviruses.
“The decision is not necessarily the receipt of a Janssen vaccine against the risk of Covid-19,” said CDC official Sara Oliver, referring to the J&J division that stands a chance. “The decision could be the reception of a Janssen vaccine versus the reception of another mRNA vaccine.”
By the summer, Pfizer and Moderna have each promised 300 million doses to the US. Pfizer said Tuesday that it is ahead of production schedule and can deliver all the photos by mid-July.
The U.S. could easily use the two shots to vaccinate its adult population, according to White House Covid-19 response coordinator Jeff Zients. But by late spring, J&J is expected to play a bigger role in the country’s vaccination plans, especially as the United States moves toward immunizing children and considers the possible need for boost shots in the coming months or years.
Members of the CDC vaccine panel argued that a prolonged hiatus from the J&J vaccine could jeopardize efforts to distribute Covid-19 vaccines fairly. Members said the shot was critical for reaching out to vulnerable populations, including the homeless and homeless.
Aran Maree, who heads Janssen’s Global Medical Organization, said the company determined that four of the women who had blood clots, known as cerebral venous sinus thrombosis or CVST, had low platelets. Three of the patients had other obstructions, including in the portal vein of the abdomen.
Maree said an additional coagulation case has been reported but that specific details are pending. Two additional CVST cases have also been reported in two different clinical trials, he said.
Neither the company nor the regulators know whether any of the known cases of coagulation involve people who were pregnant or postpartum, but one person took oral contraceptives.
Maree said five of the reported cases – one in a clinical trial and four after vaccination – were treated with the blood thinner heparin. Although heparin is commonly used to treat typical blood clots, scientists say the drug may aggravate the type of blood clots being examined for connection to the J&J vaccine.
The food and drug administration authorized J&J single dose vaccine for emergency use end of March. At the time, he expressed concern about blood clots in some trial volunteers, but said there is not enough data to establish a link with the vaccine. Although many of the people who developed in the trial lumps had underlying health issues, a 25-year-old man without conditions had a serious case. FDA advised providers to monitor for more blood clots in the general population, to learn more about potential risks.