Johnson & Johnson has agreed to revised language on the label of its Janssen coronavirus vaccine that warns of the danger of blood clots, a company official told US Centers for Disease Control and Prevention vaccine advisers on Friday.
CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting to discuss potential changes to guidance for who should get the vaccine.
CDC and the US Food and Drug Administration have paused use of the vaccine while they investigate the risk of a rare blood clotting syndrome.
Johnson & Johnson Chief Medical Officer Dr. Joanne Waldstreicher said the company had worked out revised label language with the FDA.
“We absolutely agree with the FDA on the implementation of a warning within our label and patient and physician fact sheets describing this very rare event, including how it can be identified early and diagnosed and treated,” she told ACIP.
“To that end, here is the language from our label that we have agreed upon with the FDA regarding thrombosis with thrombocytopenia.”
The revised language refers to blood clots in the brain combined with a blood clotting abnormality called thrombocytopenia. “Reports of adverse events following use of the Janssen Covid-19 vaccine … suggest an increased risk of thrombosis,” it reads, and says the relationship between the vaccine and the clots is “plausible.”
“In addition to the description of the event, health care professionals are alerted in the fact sheet to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the COVID vaccine from Janssen,” Waldstreicher said.
“It also states that symptoms began approximately one to two weeks following vaccination, and that most people were females, aged 18 through 49, and that some cases have been fatal. Health care professionals are also directed to the published American Society of Hematology considerations, relevant to the diagnosis and treatment. In addition, the patient’s fact sheet contains a clear warning and instruction. J&J strongly supports this enhanced labeling.”
ACIP will vote later Friday on whether to change recommendations.
A Johnson & Johnson official argued Friday the company’s coronavirus vaccine is valuable to both the US and the world, saying it protects against variants and is easy to distribute.
The benefit of a one-shot vaccine is “critical,” Dr. Mathai Mammen, global head of Janssen Research and Development, told a meeting of US Centers for Disease Control and Prevention vaccine advisers.
Plus, it’s easily stored at regular refrigerator temperatures for three months – as opposed to the Moderna and Pfizer vaccines, which must be stored frozen.
“We have the ability to reach locations in the United States that other vaccines may not,” Mammen told an emergency meeting of the CDC’s Advisory Committee on Immunization Practices.
Some context: ACIP is meeting to discuss whether to change guidance for J&J’s Janssen vaccine.
The CDC and the US Food and Drug Administration recommended pausing its use after six reported cases of women who developed a rare blood clotting syndrome called thrombosis with thrombocytopenia syndrome, or TTS, after receiving Johnson & Johnson’s Janssen vaccine in the United States. Now the CDC says it has learned of 15 cases, including three deaths.
That total does not include one man who experienced clots after taking the vaccine as part of the clinical trial in the fall. That case was not included in the CDC’s analysis of cases seen after the vaccine was authorized and distributed to the public.
Mammen said clinical trials have shown the Janssen vaccine offers protection quickly – within a week of the single dose. Plus, he said, it protects against concerning variants, including the B.1.351 variant that is now dominant in South Africa. The company’s data showed the vaccine had 82% efficacy in South Africa.
The Brazilian state of Sao Paulo on Friday reported a 23.6% decrease in weekly deaths from Covid-19, after eight weeks of rising death numbers.
“It is the first time that the indicators of cases, hospitalizations and deaths are falling since mid-February,” Vice Governor Rodrigo Garcia said at a news conference on Friday.
The weekly average of Covid-19 deaths in Sao Paulo state is 621, compared to 813 deaths during the previous period. The average number of cases dropped 14.3%, from 14,921 to 12,784 infected.
Starting on Saturday, restaurants, beauty salons, cinemas, gyms, and other recreational establishments will be able to reopen with attendance restrictions in Sao Paulo state.
Last week, shopping malls were able to open at 25% capacity, as well as religious events. The curfew from 8 p.m. to 5 a.m. local time has yet to be lifted.
Since the beginning of the pandemic, Sao Paulo state has registered at least 2,793,750 cases and 90,810 deaths from the novel coronavirus, according to the state’s health ministry.
So far, patients with a rare and dangerous blood clotting syndrome linked with Johnson & Johnson’s coronavirus vaccine have started showing symptoms one to two weeks after getting the vaccine, a US Centers for Disease Control and Prevention expert said Friday.
And symptoms are similar to those seen among people who experienced blood clots after getting AstraZeneca’s vaccine in Europe and the UK, the CDC’s Dr. Tom Shimabukuro told a meeting of the CDC’s Advisory Committee on Immunization Practices.
The CDC and the US Food and Drug Administration recommended pausing the use of the Johnson & Johnson vaccine after six reported cases of women who developed a rare blood clotting syndrome called thrombosis with thrombocytopenia syndrome, or TTS, after receiving the Johnson & Johnson vaccine in the United States. Now 15 cases have been reported, Shimabukuro said – all of them among women.
During the clinical trial of the vaccine last fall, one man experienced clots 21 days after taking the vaccine, according to J&J. That was case was previously presented to CDC, but was not included in the agency’s analysis of cases seen after the vaccine was authorized and distributed to the public.
“So to sum up, TTS is rare but clinically serious and potentially life threatening adverse event that has been observed in association with the Janssen Covid-19 vaccine,” Shimabukuro said.
“Symptom onset appears to occur at least several days after vaccination, typically around one to two weeks after vaccination,” he added.
“The clinical features of TTS following the Janssen Covid-19 vaccine appear similar to what is being observed following the AstraZeneca Covid-19 vaccine in Europe. It is important to recognize TTS early and initiate appropriate treatment.”
The main danger is using a common blood thinner called heparin. Other blood thinners are safe to use, and experts are also recommending use of an immune product called IVIG to restore the balance of blood-clotting cells.
“We will certainly continue our enhanced surveillance for this,” Shimabukuro said.
ACIP is expected to vote on any changes to its guidance for J&J’s vaccine later Friday. If ACIP recommends changes to the vaccine label – such as a warning, or changes to who it recommends should get the vaccine – CDC Director Dr. Rochelle Walensky will sign off and then the FDA will have to make any label changes.
The US has more than nine million doses of Johnson & Johnson’s vaccine ready to be administered if federal health officials lift their recommended pause of the one-shot vaccine, CNN has learned.
President Biden’s coronavirus adviser Jeff Zients told CNN there are more than nine million doses that have already been distributed to states, tribes, territories and federal channels that are ready to go depending on the conclusion reached by the independent vaccine advisory panel Friday.
If the pause lifts, it’s still unclear how soon those shots will start going into arms, including whether it could take hours or days. Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, will have to approve the recommendation reached by the independent panel.
The United Kingdom is looking at what can be done to help India with the Covid-19 pandemic, UK Prime Minister Boris Johnson told reporters on Friday.
“We’re now in a position where we do have 30,000 ventilators, we’re able for instance to think about what we could do to help the people of India, who are suffering so terribly at the moment,” Johnson said.
On Friday, India reported the world’s highest daily rate of Covid-19 for the second day in a row, according to a CNN tally of figures from the Indian Ministry of Health, as Delhi hospitals call for emergency oxygen supplies amid shortages.
No blood clots have been associated with coronavirus vaccines made by Moderna or Pfizer, a US Centers for Disease Control and Prevention expert said Friday.
The CDC’s Advisory Committee on Immunization Practices is meeting to discuss whether to change guidance for J&J’s Janssen vaccine. The CDC and the US Food and Drug Administration recommended pausing its use after six reported cases of women who developed a rare blood clotting syndrome called thrombosis with thrombocytopenia syndrome, or TTS, after receiving Johnson & Johnson’s Janssen vaccine in the United States. But no cases have been firmly linked with other vaccines used in the US.
“Currently, there is a lack of evidence of an association between mRNA COVID-19 vaccines and (Cerebral venous sinus thrombosis) with thrombocytopenia,” the CDC’s Dr. Tom Shimabukuro told members of the CDC’s vaccine advisory group. J&J’s vaccine is made using a common cold virus called an adenovirus, while Moderna’s and Pfizer’s vaccines are made using raw genetic material called messenger RNA.
Shimabukuro told ACIP that 2.7 million doses of Pfizer/BioNTech coronavirus vaccine and 2.5 million doses of Moderna’s vaccine had been included in CDC’s Vaccine Safety Database as of April 17. He said 10 cases of a rare type of brain blood clot called CVST were reported afterward but five were ruled out because of the medical histories of the patients, and five more were ruled out because patients did not develop a low level of platelets. It’s the combination of blood clots and low platelet counts that is linked with the vaccines.
ACIP is expected to vote on any changes to its guidance for J&J’s vaccine later Friday. If ACIP recommends changes to the vaccine label — such as a warning, or changes to who it recommends should get the vaccine — CDC Director Dr. Rochelle Walensky will sign off and then the FDA will have to make any label changes.
Dr. Rochelle Walensky, director of the US Centers for Disease Control and Prevention, said Friday the risk-benefit analysis of the Johnson & Johnson Covid-19 vaccine considers who would prefer the single-dose vaccine or wouldn’t otherwise have access to one of the two-dose vaccines currently authorized in the United States.
“I think the FDA and I feel strongly, and the CDC feel strongly, that we need to act swiftly after that analysis,” Walensky said during the White House Covid-19 briefing on Friday. “I do think that there’s plenty of people who are interested in the J&J vaccine, if just for convenience, as well as for a single-dose option.”
The CDC has been working hard over the last week to determine if there have been any additional cases of blood clots among those people who have received the Johnson & Johnson Covid-19 vaccine, Walensky said.
The J&J vaccine rollout has been on pause since April 13, after a small number of people experienced blood clots after taking the shot.
Walensky said the agency’s analysis will be presented during the Advisory Committee on Immunization Practices meeting currently underway.
European Medicines Agency officials said at a news conference on Friday that the benefits of the AstraZeneca vaccine outweigh the risks, and that they will continue to review “very rare cases” of blood clots.
“Importantly, the data show that the benefits of vaccination increased with age and increasing levels of infection in the community,” said Dr. Peter Arlett, head of Pharmacovigilance and Epidemiology Department at the European Medicines Agency.
“Every day, thousands of people in Europe are dying from Covid-19. The AstraZeneca vaccine is highly effective at preventing infection and therefore hospitalization and death,” Arlett added. “Very rare cases of blood clots with low platelets have been reported, and these are listed as very rare side effects of the vaccine.”
Arlett also said the European Medicines Agency is stepping back from reporting the numbers on blood clots, as the agency wants to contextualize the numbers and the risk.
Earlier this month, the EMA said a particular combination of unusual blood clots with low blood platelet counts should be listed as a side effect of the AstraZeneca vaccine, but stopped short of recommending its use be limited. The agency previously said the positive benefits of AstraZeneca’s vaccine outweigh the risks.