Breaking News
0
Ad-Free Version. Upgrade your Investing.com experience. Save up to 40% More details

U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe

CoronavirusApr 13, 2021 06:45PM ET
Saved. See Saved Items.
This article has already been saved in your Saved Items
 
2/2 © Reuters. FILE PHOTO: Vials and medical syringe are seen in front of J&J logo in this illustration 2/2

By Michael Erman and Manas Mishra

(Reuters) - U.S. federal health agencies on Tuesday recommended pausing use of Johnson & Johnson (NYSE:JNJ)'s COVID-19 vaccine for at least a few days after six women under age 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

Johnson & Johnson said it would delay rollout of the vaccine to Europe, a week after regulators there said they were reviewing rare blood clots in four recipients of the shot in the United States. South Africa also suspended use of J&J's vaccine.

Acting U.S. Food and Drug Administration Commissioner Janet Woodcock said the agency expected the pause to be a matter of days, and was aimed at providing information to healthcare providers on how to diagnose and treat the clots.

The moves come after European regulators said earlier this month they had found a possible link between AstraZeneca (NASDAQ:AZN)'s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

FDA official Peter Marks said it was "plainly obvious" the J&J cases were "very similar" to the AstraZeneca ones. He said there had been no similar blood clot cases reported among recipients of the Moderna (NASDAQ:MRNA) or Pfizer/BioNTech vaccines, which use a different technology and accounted for the vast majority of U.S. vaccinations so far.

But J&J's single-dose shot and AstraZeneca's low-cost vaccine are seen as vital weapons in the fight against a pandemic that has claimed more than three million lives.

Immunology experts echoed U.S. officials in underscoring that the risk posed by the J&J vaccine appeared extremely low.

"Even if causally linked to the vaccine: 6 cases with about 7 million doses ... is not something to panic about," Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email, noting that the risk appears lower than that of clots from oral contraceptives.

He expressed concern that the pause could increase hesitancy to get vaccinated.

The FDA said there had been one reported death from the rare blood clotting condition among recipients of the J&J vaccine, while another person was in a critical condition.

The White House said appointments to receive the J&J shot were being rescheduled across the country to the other two authorized vaccines, and that there was enough supply of Pfizer (NYSE:PFE) and Moderna shots to hit President Joe Biden's goal of administering 200 million shots during his first 100 days in office.

"There's enough vaccine - that is basically 100% unquestionable - for every single, solitary American," Biden told reporters.

Graphic: U.S. COVID-19 vaccine doses administered, by type - https://graphics.reuters.com/HEALTH-CORONAVIRUS/JOHNSON-JOHNSON-VACCINE/xegvbxmeovq/chart.png

BALANCE OF RISKS

J&J's vaccine rollout has been limited by production issues. As of April 13, 7.2 million doses of the J&J vaccine had been administered in the United States compared with 185 million of the other two.

An advisory committee to the U.S. Centers for Disease Control and Prevention will meet on Wednesday to review the clotting cases and vote on recommendations for future use of the shot. The FDA will then review the analysis.

All six cases involved women between the ages of 18 and 48, with symptoms occurring six to 13 days after vaccination. The FDA said patients should watch for up to three weeks for symptoms including severe headache, abdominal pain, leg pain or shortness of breath.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets, or thrombocytopenia.

J&J, whose shares closed down 1.3%, said it was working closely with regulators and noted no clear causal relationship had been established between the clots and its vaccine.

"To put this into perspective, it's similar to the chance of being struck by lightning in any given year in the UK. On the other hand, the risks from COVID-19 are substantial," said Ian Douglas from the London School of Hygiene & Tropical Medicine.

The J&J and AstraZeneca vaccines both use an adenovirus - a harmless cold virus - as a vector to deliver instructions for human cells to produce a protein found on the surface of the coronavirus, spurring the immune system to recognize and attack the actual virus.

Chinese and Russian COVID-19 vaccine developers CanSino Biological and Gamaleya Institute also rely on this approach. The Pfizer/BioNTech and Moderna vaccines use messenger RNA (mRNA) technology.

The European Medicines Agency (EMA) recommends AstraZeneca's COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

As of April 4, the EMA said 169 cases of CVST and 53 of splanchnic vein thrombosis had been reported after vaccination with the AstraZeneca shot. About 34 million people had been given the shot in Europe by then.

J&J only began delivering its COVID-19 vaccine to European Union countries this week.

Graphic: J&J COVID-19 vaccine doses administered in the U.S. - https://graphics.reuters.com/HEALTH-CORONAVIRUS/JOHNSON-JOHNSON-VACCINE/qmyvmlgyypr/chart.png

U.S. pauses use of J&J vaccine over rare blood clots, rollout delayed in Europe
 

Related Articles

Add a Comment

Comment Guidelines

We encourage you to use comments to engage with users, share your perspective and ask questions of authors and each other. However, in order to maintain the high level of discourse we’ve all come to value and expect, please keep the following criteria in mind: 

  • Enrich the conversation
  • Stay focused and on track. Only post material that’s relevant to the topic being discussed.
  • Be respectful. Even negative opinions can be framed positively and diplomatically.
  •  Use standard writing style. Include punctuation and upper and lower cases.
  • NOTE: Spam and/or promotional messages and links within a comment will be removed
  • Avoid profanity, slander or personal attacks directed at an author or another user.
  • Don’t Monopolize the Conversation. We appreciate passion and conviction, but we also believe strongly in giving everyone a chance to air their thoughts. Therefore, in addition to civil interaction, we expect commenters to offer their opinions succinctly and thoughtfully, but not so repeatedly that others are annoyed or offended. If we receive complaints about individuals who take over a thread or forum, we reserve the right to ban them from the site, without recourse.
  • Only English comments will be allowed.

Perpetrators of spam or abuse will be deleted from the site and prohibited from future registration at Investing.com’s discretion.

Write your thoughts here
 
Are you sure you want to delete this chart?
 
Post
Post also to:
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Thanks for your comment. Please note that all comments are pending until approved by our moderators. It may therefore take some time before it appears on our website.
 
Are you sure you want to delete this chart?
 
Post
 
Replace the attached chart with a new chart ?
1000
Your ability to comment is currently suspended due to negative user reports. Your status will be reviewed by our moderators.
Please wait a minute before you try to comment again.
Add Chart to Comment
Confirm Block

Are you sure you want to block %USER_NAME%?

By doing so, you and %USER_NAME% will not be able to see any of each other's Investing.com's posts.

%USER_NAME% was successfully added to your Block List

Since you’ve just unblocked this person, you must wait 48 hours before renewing the block.

Report this comment

I feel that this comment is:

Comment flagged

Thank You!

Your report has been sent to our moderators for review
Disclaimer: Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. All CFDs (stocks, indexes, futures) and Forex prices are not provided by exchanges but rather by market makers, and so prices may not be accurate and may differ from the actual market price, meaning prices are indicative and not appropriate for trading purposes. Therefore Fusion Media doesn`t bear any responsibility for any trading losses you might incur as a result of using this data.

Fusion Media or anyone involved with Fusion Media will not accept any liability for loss or damage as a result of reliance on the information including data, quotes, charts and buy/sell signals contained within this website. Please be fully informed regarding the risks and costs associated with trading the financial markets, it is one of the riskiest investment forms possible.
Continue with Google
or
Sign up with Email