The Jerusalem Post

J&J’s vaccine in limbo over rare blood clots


Johnson & Johnson’s COVID-19 vaccine remained in limbo on Wednesday as a US health panel called for more data before making a decision on how and whether to resume use of the onedose shot, putting off a vote for a week or more.

The US Centers for Disease Control and Prevention (CDC) advisory panel decided to delay a vote on how best to use the J&J shot even after a US Food and Drug Administra­tion scientist told advisers he believed warnings could mitigate the risk of extremely rare but serious blood clots.

The panel is reviewing six reported cases of rare brain blood clots in women who received the J&J vaccine, a day after the FDA and CDC jointly recommende­d pausing its use to assess the issue.

Dr. Lynn Batha, an epidemiolo­gist at the Minnesota health department, and several others spoke in favor of extending the pause to gather more safety informatio­n.

“By having more robust informatio­n, I think we can be more confident about how we talk about the safety of this vaccine,” she told other members of the advisory panel.

Earlier, the FDA’s deputy director for vaccine developmen­t, Doran Fink, told the panel that his current thinking was that warning statements and communicat­ions from the federal agency would allow doctors to weigh risks and benefits of the vaccine.

Other panel members and advisers, however, expressed concern that extending the pause could worsen issues related to equitable access to the vaccine, which is seen as important for serving hard-to-reach communitie­s because it can be stored at normal refrigerat­or temperatur­es and given as one dose instead of two.

“Any extension of the pause will invariably result in the fact that the most vulnerable individual­s in the United States will remain vulnerable,” Nirav Shah, director of the Maine Center for Disease Control and Prevention and a representa­tive of the Associatio­n of State and Territoria­l Health Officials told the panel. Shah is not a voting member.

Several panel members wanted to vote to extend the pause by as much as a month, but Dr. Beth Bell, a global health expert at the University of Washington, argued that would send a signal globally of a major issue with the vaccine.

“I don’t want to send the message that there is something fundamenta­lly wrong with this vaccine, which I don’t agree with,” she said.

“It’s a very rare event,” Bell said of the cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets. “Nothing is risk-free.”

The six cases, all in women under age 50, were reported out of 7.2 million doses of the J&J vaccine administer­ed in the United States – a risk federal health officials and immunology experts said was extremely low, especially when weighed against the potential ravages of COVID-19.

One of the six women died and three remain hospitaliz­ed. So far, more than 562,000 people in the United States have died from COVID-19.

Bell argued in favor of postponing a vote and gathering more informatio­n, which the panel decided to do.

The FDA is charged with weighing evidence on a vaccine’s safety and effectiven­ess, and could add warnings to existing labeling. The panel’s role is to advise public health officials and the CDC director on how best to use vaccines once they are approved.

The FDA in an email to Reuters said it is continuing to review the vaccine safety data, in partnershi­p with the CDC, and will provide updates on additional scientific evidence as they become available.

“It’s important that these deliberati­ve processes that protect patients are followed so that the American public has confidence in vaccine safety and effectiven­ess,” the FDA added. (Reuters)

senior officials.

“So currently, we should do away with all disruptive factors, moving forward as swiftly as we can on the work of negotiatio­n, especially by zeroing in on sanctions-lifting.”

Iran’s Foreign Ministry said its negotiator­s had defended their decisions and expressed their disappoint­ment at “the weak reaction” from European powers to the attack on Natanz.

Highlighti­ng Western concerns, a senior diplomat said that while the desire was to make progress, Iran’s latest violation could not be ignored and have made efforts to achieve a breakthrou­gh before the June 18 Iranian presidenti­al election harder.

“The seriousnes­s of Iran’s latest decisions has hurt this process and raised tensions,” said the senior Western diplomat.

“We will have to see how, in the coming days, we address these violations with the will to press ahead in the talks.”

Tehran has repeatedly said that all sanctions must be rescinded first, warning that it may stop negotiatio­ns if the measures are not lifted. The US wants Iran to reverse the breaches of the deal that it made in retaliatio­n for tough sanctions imposed by former President Donald Trump.

“Iran’s “seriousnes­s of purpose” in pursuing diplomacy was tested in the three years since Trump withdrew from the nuclear accord,” Iranian Foreign Minister Mohammad Javad Zarif said on Twitter. “Iran – by remaining in the deal – passed with flying colors. The Biden administra­tion, however, has only shown a commitment to Trump’s maximum pressure.”

Enrique Mora, EU chief coordinato­r for the talks, said in a tweet it was good to see participan­ts resume the talks “despite very challengin­g events and announceme­nts over the past days.”

Israel, which Iran refuses to recognize, opposes the deal, an accord that Tehran and US President Joe Biden are trying to revive after Trump left it in 2018. Israel has not formally commented on Sunday’s Natanz incident.

The United Arab Emirates, which also supported the decision to quit the 2015 accord and reimpose sanctions on Tehran, urged Washington to push for a better accord. A Gulf diplomatic source said the Riyadh-based Gulf Cooperatio­n Council had sent letters

to global powers stressing the need for Gulf involvemen­t in ongoing negotiatio­ns.

Sunday night, when the site’s electric grid and backup system were destroyed, along with large numbers of centrifuge­s. The assassinat­ion was of the head of Iran’s nuclear program, Mohsen Fakhrizade­h, in November.

“Before this, documents from our entire nuclear [archive] have been stolen, and before that, a few suspicious drones came and did some work,” Rezaei added.

When the Mossad smuggled the nuclear archive out of Iran in 2018, with Prime Minister Benjamin Netanyahu presenting evidence that the Islamic Republic aimed to develop a nuclear weapon, Iran denied that it was real. Iran nuclear negotiator Abbas Araghchi called it “a very childish and even a ridiculous play.” Mohammad Marandi, one of Iran’s negotiator­s in the 2015 nuclear deal, said Israel had “fabricated evidence.”

Rezaei said this week’s attack on Natanz was “a bad event in terms of prestige,” and that “they did it to break our resistance in diplomacy.”

Fereydoon Abbasi-Davani, former head of Iran’s Atomic Energy Organizati­on, said earlier this week that Sunday’s attack damaged thousands of centrifuge­s. “The design of the enemy was very beautiful,” he said.

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