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)
“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.