April 23 coronavirus news

By Sophie Jeong, Aditi Sangal and Kara Fox, Nicholas Pearce and Philip Wang

Updated 0702 GMT (1502 HKT) April 26, 2021
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3:45 p.m. ET, April 23, 2021

CDC advisers are considering 4 choices on J&J vaccine, including a complete end to its use

From CNN’s Maggie Fox

Vaccine advisers to the US Centers for Disease Control and Prevention are considering four choices for changing the agency’s recommendation on Johnson & Johnson’s coronavirus vaccine, including label changes or a complete end to its use.

The CDC’s Advisory Committee on Immunization Practices is holding an emergency meeting and is expected to vote later Friday on recommendations.

At issue: The vaccine has been linked to 15 cases of a rare blood clotting condition called thrombosis with thrombocytopenia syndrome, or TTS, all among women. Three have died.

It’s a tricky question because all but two cases have been in women under the age of 50, and no cases have been reported among men since the vaccine has been in general use, although the CDC says it’s unlikely the risk is zero among men. 

CDC staff laid out several possible scenarios, all of which show that while resuming vaccination would result in more cases of blood clots, adding the J&J shot to the mix of available vaccines would save lives and keep people out of the hospital.

The committee’s four possible choices are:

  • Recommend against use for all persons
  • Reaffirm recommendation for all age and sex – US Food and Drug Administration to include warning statement with emergency use authorization
  • Recommend vaccination only for adults aged 50 or older
  • Reaffirm recommendations for use; women aged under 50 should be aware of the increased risk of TTS, and may choose another Covid-19 vaccine (ie mRNA vaccines)

Earlier, Johnson & Johnson officials said they had agreed with the FDA on new wording to add to the label saying the risk of blood clots is plausible and warning of the risks.

 

3:35 p.m. ET, April 23, 2021

CDC: Resuming use of J&J vaccine would save lives and result in at most a few dozen cases of rare blood clots

From CNN’s Maggie Fox, Alicia Lee and Christian Sierra

A dose of the Johnson & Johnson COVID-19 vaccine is prepared at an event put on by the Thornton Fire Department on March 6 in Thornton, Colorado.
A dose of the Johnson & Johnson COVID-19 vaccine is prepared at an event put on by the Thornton Fire Department on March 6 in Thornton, Colorado. Michael Ciaglo/Getty Images

Resuming use of Johnson & Johnson’s coronavirus vaccine would save hundreds of lives and result in at most a few dozen cases of rare blood clots, a US Centers for Disease Control and Prevention analysis shows.

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 called thrombosis with thrombocytopenia syndrome, or TTS. The CDC has reports of 15 cases, all in women, and 13 of them in women under the age of 50. Three have died.

The CDC’s Dr. Sara Oliver presented the results of several models laying out what might happen if the vaccine is used again, including with restrictions on use in certain groups. The CDC took into consideration deaths from coronavirus and the likelihood that people would get vaccinated more quickly if the Johnson & Johnson vaccine was in the mix.

“When resuming vaccination among all persons at least 18 years, we expect 26 to 45 TTS cases depending on vaccine uptake,” she said. But 600 to 1,400 deaths from Covid-19 would be prevented, and as many as 3,500 intensive care unit admissions would be prevented. 

If the vaccine were restricted to people over the age of 50, three TTS cases could be expected, but between 40 and 250 Covid-19 deaths would be prevented, and as many as 1,000 people would not need treatment in the ICU. 

For every million doses of vaccine given to women ages 18 to 49, 13 TTS cases can be expected, Oliver said. But 12 deaths from Covid-19 would be prevented and 127 ICU admissions would be prevented among those women if they had access to the Johnson & Johnson vaccine.

 The CDC did not consider a gender-based restriction, Oliver said, because it would be too hard to explain – even though the risk of blood clots appears to be very low among men.

“There are also benefits beyond efficacy. This vaccine is able to be shipped and stored at refrigerator temperatures, and as a single dose series, which may make it easier to reach some disproportionately affected groups,” Oliver said.

“We note that the benefits of vaccination apply to the whole population over a six month period and result from both direct and indirect effects,” she added.

 

3:36 p.m. ET, April 23, 2021

US adds more than 3 million Covid-19 vaccine shots

From CNN’s Virginia Langmaid

Otto Delcid is inoculated with the Pfizer-BioNTech Covid-19 vaccine by nurse Nicole Colon at the UMass Memorial Health Care COVID-19 Vaccination Center in the Mercantile Center in Worcester, Massachusetts, on April 22.
Otto Delcid is inoculated with the Pfizer-BioNTech Covid-19 vaccine by nurse Nicole Colon at the UMass Memorial Health Care COVID-19 Vaccination Center in the Mercantile Center in Worcester, Massachusetts, on April 22. Joseph Prezioso/AFP/Getty Images

The United States added more than 3.3 million Covid-19 vaccine shots to its cumulative tally Friday, according to data from the US Centers for Disease Control and Prevention. 

This is the largest single-day increase reported this week, but still leaves the United States short of the daily average peak reached in early April. 

The seven-day average of new Covid-19 shots reported administered continued to fall, and now sits at 2,862,758. This is the second consecutive day this average has been under 3 million. The United States has not seen a seven-day average for vaccination below 3 million for two days in a row since April 2.

The average pace of new shots reported administered has been greater than 3 million shots per day for most of April, reaching a peak of nearly 3.4 million shots per day on April 13.  

By the numbers: More than 200 million Covid-19 vaccine shots have been reported administered since President Biden took office, reaching a threshold the administration had set for Biden’s 100th day in office about a week early.

About 41% of the US population – over 137 million people – have received at least one dose of Covid-19 vaccine, and about 28% of the population – more than 90 million people – are fully vaccinated, CDC data shows. 

Note: Data published by the CDC may be delayed, and doses may not have been given on the day reported. 

3:16 p.m. ET, April 23, 2021

CDC advisers begin J&J vaccine vote discussion

From CNN's Jacqueline Howard

Members of the Advisory Committee on Immunization Practices have started discussions about what updated recommendation they may have for the Johnson & Johnson vaccine.

A vote is expected following the deliberations.

2:53 p.m. ET, April 23, 2021

J&J says link to blood clots with its Covid-19 vaccine is "plausible" and suggests possible label change

From CNN’s Maggie Fox, Christian Sierra and Alicia Lee

A syringe is filled with a dose of the Johnson & Johnson Janssen Covid-19 vaccine at a vaccination site inside Reuther Hall at Forty Acres on March 13 in Delano, California.
A syringe is filled with a dose of the Johnson & Johnson Janssen Covid-19 vaccine at a vaccination site inside Reuther Hall at Forty Acres on March 13 in Delano, California. Patrick T. Fallon/AFP/Getty Images

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.

2:42 p.m. ET, April 23, 2021

Johnson & Johnson says its coronavirus vaccine is valuable and protects against variants

From CNN’s Alicia Lee, Christian Sierra and Maggie Fox

Doses of the Johnson & Johnson COVID-19 vaccine are prepared at a clinic on March 25 in Los Angeles.
Doses of the Johnson & Johnson COVID-19 vaccine are prepared at a clinic on March 25 in Los Angeles. Mario Tama/Getty Images

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. 

2:34 p.m. ET, April 23, 2021

Brazil's Sao Paulo state reports more than 20% decrease in weekly Covid-19 deaths 

From Rodrigo Pedroso

Workers bury a coffin at the Vila Formosa cemetery in Sao Paulo, Brazil, on April 17.
Workers bury a coffin at the Vila Formosa cemetery in Sao Paulo, Brazil, on April 17. Miguel Schincariol/AFP/Getty Images

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.

1:16 p.m. ET, April 23, 2021

Rare blood clots cause symptoms 1 to 2 weeks after Covid-19 vaccination, CDC expert says

From CNN’s Maggie Fox, Alicia Lee and Christian Sierra 

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. 

1:12 p.m. ET, April 23, 2021

US has more than 9 million Johnson & Johnson doses ready to go if pause lifts

From CNN's Kaitlan Collins

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.