FDA recommends pause of Johnson & Johnson COVID-19 vaccine: What we know

J&J's has administered more than 6.8M COVID-19 vaccine doses

Federal health officials recommended a "pause" in administering Johnson & Johnson's single-dose COVID-19 vaccine Tuesday "out of an abundance of caution" following reports of potentially dangerous blood clots.

U.S. federal distribution channels, including mass vaccination sites, will pause the use of the J&J shot as the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) investigate clots in six women in the days after vaccination, in combination with reduced platelet counts. 

States and other providers are expected to follow.

Here's what we know. 

Doses Administered 

To date, more than 6.8 million doses of the J&J vaccine have been administered. In 2020, the company entered into an agreement with the U.S. government -- valued at more than $1 billion -- to develop and deliver 100 million doses. 

The pharmaceutical giant also aimed to supply more than one billion doses globally through the course of 2021 but said it would only do so "as long as the vaccine is safe and effective." 

FDA RECOMMENDS PAUSE OF JOHNSON & JOHNSON COVID-19 VACCINE AFTER BLOOD CLOT CASES

Investor Reaction

J&J's stock was under pressure Tuesday after the FDA and CDC issued their joint statement on the blood clots. So far this year the stock has gained 2.7% and over 15% for the past 12 months. However, Moderna shares rose after the company maker distanced its vaccine from the same side effects. 

MODERNA DEFENDS ITS COVID-19 VACCINE AFTER J&J SETBACK

Ticker Security Last Change Change %
JNJ JOHNSON & JOHNSON 170.19 +0.35 +0.21%
MRNA MODERNA, INC. 161.38 +11.51 +7.68%

Astra-Zeneca has also had its vaccine curbed in Europe during the last few weeks. 

Ticker Security Last Change Change %
AZN ASTRAZENECA PLC 55.21 +0.16 +0.29%

Other vaccine makers will also be in focus on the developments. 

Ticker Security Last Change Change %
PFE PFIZER INC. 40.00 -0.12 -0.30%
BNTX BIONTECH SE 192.77 +11.98 +6.63%

 

Here's What Next

A press conference will be held at 10 a.m. ET on Tuesday to provide further details to the public and is available to view on the FDA's YouTube Channel.

The CDC’s Advisory Committee on Immunization Practices will meet Wednesday morning to discuss the cases and the FDA has also launched an investigation of the cases.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Anne Schuchat, principal deputy director of the CDC, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a joint statement.

Representatives for Johnson & Johnson have not immediately responded to FOX Business' request for comment. 

The Associated Press contributed to this report.