AHF Demands Full Transparency as J&J and FDA Balk at Sharing COVID VAX Trial Info

• Despite a widely-touted recent joint pledge of prudence and caution on vaccine trial safety by nine drug companies working on COVID 19 vaccines, most fall far short on even the most basic transparency
• CNN reported today that a week after it paused its COVID-19 vaccine trial on Oct. 12th, Johnson & Johnson and the FDA both refused to release any information about the paused trial, with the FDA citing federal regulations as the reason it could not share any information from the trials

WASHINGTON--(BUSINESS WIRE)-- AIDS Healthcare Foundation (AHF), the largest global AIDS organization, today sharply criticized Johnson & Johnson (J&J) and the United States Food and Drug Administration (FDA) for their refusal to release any information regarding a COVID-19 vaccination trial that J&J paused earlier this month, with the FDA citing federal regulations as its reason for its refusal to share any information. The refusal to share data or even basic information about the study and the pause comes on the heels of a recent and widely-touted joint pledge of prudence and caution on vaccine trial safety by nine drug companies, including J&J, working on COVID 19 vaccines.

AHF is calling for far greater transparency from J&J, the FDA and other drug companies working on COVID vaccines—at least three of which have been paused or halted, according to the New York Times. Currently, most fall far short on even the most basic levels of transparency.

In J&J’s case, both J&J and the FDA “…declined to answer two questions from CNN: 1) Whether the participant who became ill was in the group that received the vaccine or the placebo, and 2) Whether this was the first pause for the trial.”

“It is worth saying it again: full transparency on COVID 19 vaccine trials, including stumbles and pauses, is essential to public trust,” said AHF President Michael Weinstein. “Despite corporate culture and potential market and/or political pressures, leaders at J&J, the FDA, and in fact all these drug companies, must be fully transparent about their vaccine trials. The damage done to the public trust from lack of transparency could be so great and so long-lasting that it could severely affect uptake of an eventual successful COVID vaccine as well as any other vaccines that follow.”

AHF also repeated its call on the global public health community and governments to exercise caution and due diligence in fast-tracking vaccine candidates for prevention of COVID-19.

Since the beginning of the pandemic, COVID-19 has infected 40.3 million people and claimed over 1.1 million lives. The devastating effects of the pandemic on all aspects of human activity cannot be understated. The impact of the virus on public health, the global economy, politics and civic institutions will likely be felt for generations. Amid this crisis, the possibility of an effective vaccine for COVID-19 holds a hopeful promise for a gradual end to the pandemic.

Vaccines have saved millions of lives across the world from death, disability, and illness. Smallpox, which typically killed 30% of infected patients, was eradicated in 1980 thanks to an effective vaccine. Polio, a crippling disease primarily affecting children, has been eradicated in many parts of the world as a result of a concerted vaccination campaign spanning decades.

For more information, please contact Ged Kenslea at gedk@aidshealth.org or (323) 791-5526

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.4 million people in 45 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.

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