April 13 coronavirus news

By Jessie Yeung, Lauren Said-Moorhouse, Samantha Tapfumaneyi, Melissa Mahtani, Melissa Macaya and Meg Wagner, CNN

Updated 0619 GMT (1419 HKT) April 14, 2021
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12:01 p.m. ET, April 13, 2021

FDA official says similarities between J&J and AstraZeneca vaccines are "plainly obvious"

From CNN's Jacqueline Howard

A dose of the Johnson & Johnson coronavirus vaccine is prepared on April 7 in New York City.
A dose of the Johnson & Johnson coronavirus vaccine is prepared on April 7 in New York City. Michael M. Santiago/Getty Images

There appears to be similarities between the rare blood clotting events possibly associated with Johnson & Johnson’s coronavirus vaccine and the AstraZeneca coronavirus vaccine, Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday. 

"It's plainly obvious to us already that what we're seeing with the Janssen vaccines looks very similar to what was being seen with the AstraZeneca vaccine," Marks said. Janssen is the vaccine arm of Johnson & Johnson. 

The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as "very rare side effects" of the AstraZeneca vaccine. The AstraZeneca vaccine isn't in use in the United States but has been authorized in other countries. 

"The AstraZeneca is a chimpanzee adenoviral vector vaccine. The Janssen is a human adenoviral vector vaccine," Marks said. "We can't make some broad statement yet, but obviously they are from the same general class of viral vectors."

The mechanism behind the blood clotting events among those who have received the Johnson & Johnson vaccine remains unknown – but may be similar to the mechanism behind possible events connected to the AstraZeneca vaccine, Marks said.

"We don't have a definitive cause, but the probable cause that we believe may be involved here – that we can speculate – is a similar mechanism that may be going on with the other adenoviral vector vaccine," Marks said. "That is that this is an immune response that occurs very, very rarely after some people receive the vaccine and that immune response leads to activation of the platelets and these extremely rare blood clots."

11:29 a.m. ET, April 13, 2021

No clear link between potential J&J vaccine clotting events and birth control, FDA official says

From CNN's Jacqueline Howard

The rare blood clotting events among six people who have received the Johnson & Johnson coronavirus vaccine do not appear to be connected to birth control, but the events are still being investigated, Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.

"At this time, it's not clear that there's any association with the oral contraceptive pill birth control in the individuals who had these blood clots," Marks said.

Overall, Marks added that it's too early to tell exactly how many blood clotting events may have occurred or may emerge in connection to the vaccine.

"I think it's too early to make any speculation on how many cases will come out," Marks said. "It's possible we will learn of more cases and that's part of the reason why we're taking the pause to try to ascertain that, but I cannot speculate on how many more we'll learn of. Hopefully, it's just going to be a few."
11:34 a.m. ET, April 13, 2021

Rio de Janeiro had more deaths than births for sixth month in row, government data shows

From CNN's Rodrigo Pedrosa and Mitchell McCluske

A general view of Caju cemetery is seen on March 24 in Rio de Janeiro, Brazil.
A general view of Caju cemetery is seen on March 24 in Rio de Janeiro, Brazil. Buda Mendes/Getty Images

Rio de Janeiro, the second most populous city in Brazil, registered more deaths than births for the sixth month in a row ending in March, according to the Brazil’s civil registry.

There were 16% more deaths than births in Rio de Janeiro since October, with a total of 36,437 deaths and 32,060 births in those six months, according to the civil registry.

The city has been facing a surge in Covid-19 cases and deaths in the past months. When the pandemic reached its peak in the region last year, in May and June, Rio de Janeiro registered 52% more deaths than births.

Since the beginning of the pandemic, in March 2020, Rio de Janeiro had more births than deaths in only five out of thirteen months, according to the civil registry.

Rio de Janeiro currently has 237,974 confirmed cases of Covid-19 and 21,752 deaths, according to figures from the municipal health secretariat.

11:10 a.m. ET, April 13, 2021

US blood clot events after vaccination tied to 1 fatality

From CNN's Jacqueline Howar

One person who experienced a rare type of blood clot after receiving the Johnson & Johnson coronavirus vaccine has died and another is in critical condition, Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday.

"Of the clots seen in the United States, one case was fatal and one patient is in critical condition," Marks said. "While we review the available data, out of an abundance of caution, the FDA and CDC are recommending a pause in the use of this vaccine in the United States."

The US Centers for Disease Control and Prevention and the FDA are recommending that the United States pause the use of Johnson & Johnson's coronavirus vaccine following six reported US cases of a rare and severe type of blood clot.

All six cases occurred among women between the ages of 18 and 48, the CDC and FDA said, and symptoms occurred 6 to 13 days after vaccination. 

11:14 a.m. ET, April 13, 2021

Acting FDA commissioner expects J&J Covid-19 vaccine pause to last "a matter of days"

From CNN Health’s Ashley Ahn)

Doses of the Johnson & Johnson Covid-19 vaccine are prepared at a clinic in Los Angeles, California, on March 25.  
Doses of the Johnson & Johnson Covid-19 vaccine are prepared at a clinic in Los Angeles, California, on March 25.   Frederic J. Brown/AFP/Getty Images

Dr. Janet Woodcock, acting commissioner of the US Food and Drug Administration, said she expects the pause of the Johnson & Johnson’s Covid-19 vaccine to be “a matter of days.”

“The timeframe will depend, obviously, on what we learn in the next few days,” Woodcock said at a news briefing on Tuesday. “However, we expect it to be a matter of days for this pause.”

The US Centers for Disease Control and Prevention and the FDA recommended the US pause the use of the Johnson & Johnson vaccine after six cases of a “rare and severe” blood clot were reported among the more than 6.8 million doses of the vaccine administered in the US.

The CDC will hold an emergency meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow from 1:30 p.m. to 4 p.m. ET to review the blood clot cases. The FDA will also review the ACIP’s analysis as it investigates the cases.

Dr. Anne Schuchat, principal deputy director of the CDC, said Tuesday that the intent is to “provide an update regularly.”

“We are committed to an expeditious review of the available information, and to an aggressive outreach to clinicians so that they know how to diagnose, treat and report,” Schuchat said. “One of the things that the ACIP’s deliberation will do is review the data on the cases, and the context of risks, benefits and possible subsets of the population that may be in a different category."

11:17 a.m. ET, April 13, 2021

Doctors and patients can decide whether to receive J&J vaccine, FDA official says

From CNN's Adrienne Vogt

A nurse prepares a Johnson & Johnson Covid-19 vaccine dose on March 25, in Los Angeles, California.
A nurse prepares a Johnson & Johnson Covid-19 vaccine dose on March 25, in Los Angeles, California. Frederic J. Brown/AFP/Getty Images

Dr. Peter Marks, director of the US Food and Drug Administration's Center for Biologics Evaluation & Research, said the recommendation to pause the Johnson & Johnson Covid-19 vaccine over blood clot concerns is "not a mandate."

“It's out of an abundance of caution we're recommending that the vaccine be paused in terms of its administration,” Marks said. “However, if an individual health care provider has a conversation with an individual patient and they determine that the benefit risk for that individual patient is appropriate, we're not going to stop that provider from administering the vaccine, because it could be right in many cases that benefit risk will be beneficial overall to that individual.” 

“A provider and patient can make the determination whether or not to receive the vaccine,” Marks said. 

Dr. Anne Schuchat, principal deputy director of the US Centers for Disease Control and Prevention, said that 121 million people have been vaccinated with at least one dose of one of the three vaccines.

"With our intensive safety monitoring, we have not detected this type of syndrome with the low platelets among the other vaccines," she said. "So we're taking this pause and precautions around the J&J product in the context of a large, robust, and highly safe and effective vaccination effort."

10:55 a.m. ET, April 13, 2021

Clotting events may be activated by immune response after vaccination, FDA leaders say

From CNN’s Virginia Langmaid

Clotting events that may be linked to Johnson & Johnson’s Covid-19 vaccine could be a result of an immune response, Dr. Peter Marks, director of the United States Food and Drug Administration’s Center for Biologics Evaluation and Research said on Tuesday. 

“We don’t have a definitive cause, but the probable cause that we believe may be involved here that we can speculate, is a similar mechanism that may be going on with other the other adenoviral vector vaccine,” Marks said in a media call. “That is an immune response to that occurs very, very rarely after some people receive the vaccine. And that immune response, leads to activation of the platelets and these extremely rare blood clots.”

Acting FDA Director Janet Woodcock called this the “leading” theory on the clotting response right now.

“The person being vaccinated makes an immune response potentially that actually involves their own platelets or other parts of the coagulation system and can cause this problem,” Woodcock said. “That's the sort of leading theory or hypothesis about what's going on here.”

10:50 a.m. ET, April 13, 2021

CDC vaccine advisers will meet about Johnson & Johnson Covid-19 vaccine at 1:30 p.m. ET Wednesday 

From CNN's Ashley Ahn

The US Centers for Disease Control and Prevention will hold an emergency meeting of its Advisory Committee on Immunization Practices, or ACIP, from 1:30 to 4 p.m. ET Wednesday to review “rare and severe” blood clot cases among people who received the Johnson & Johnson Covid-19 vaccine. 

The meeting will be virtual, with no in-person attendance.

The CDC and the US Food and Drug Administration have recommended that the United States pause the use of the Johnson & Johnson vaccine until the review is complete. 

The FDA will also review the ACIP’s analysis as it investigates the cases, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” the statement said. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."
10:49 a.m. ET, April 13, 2021

FDA official explains quick decision on pausing J&J vaccine

From CNN's Jacqueline Howard

The US Food and Drug Administration and US Centers for Disease Control and Prevention quickly made the recommendation to pause the use of the Johnson & Johnson coronavirus vaccine – even without giving states a heads up – because of concern that rare blood clot incidents might be treated inappropriately. 

The rare type of blood clots observed in association with the vaccine require unique treatment, officials said. The six reported cases were among more than 6.8 million doses of the vaccine administered in the US.

"The issue here with these types of blood clots is that if one administers the standard treatment that we as doctors have learned to give for blood clots, one can cause tremendous harm," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a virtual briefing on Tuesday. 

Marks added that health care providers had to be made aware of the pause immediately in case they see patients with possible blood clot symptoms.

"This was taken rapidly in order to honor our commitment to the American public to ensure that any safety signal was fully addressed in a transparent matter," Marks said.

Acting FDA Commissioner Dr. Janet Woodcock also said during the briefing that the decision to recommend a pause was made quickly to alert the health care community.

"I wish that we had more time to get everyone prepared and that this could go even more smoothly. As we learned about the issue with appropriate treatment, it was clear to us that we needed to alert the public," Woodcock said. "We included the pause in addition to the alert so that there was time for the health care community to learn what they needed to learn about how to diagnose, treat and report, but the decision was based on the events that might occur between when we made that realization and when we got the word out."