Johnson & Johnson halted clinical trials of its Covid-19 vaccine after a participant fell ill, the second time that a front-runner developer has paused testing in the race to create a viable immunization against the virus. The participant’s illness is being evaluated, the New Brunswick, New Jersey-based company said late Monday, adding that it would share information after further investigation.
The vaccine is undergoing tests in as many as 60,000 volunteers from Peru to South Africa. J&J is racing along with rivals such as Moderna Inc., Pfizer Inc. and AstraZeneca Plc to deliver a shot to help blunt the pandemic. Drugmakers must balance time pressures — especially as coronavirus cases set new records — with safety considerations in the crucial last stage of testing. “We’re going to have to get used to hearing these sorts of reports of pauses,” Hassan Vally, an associate professor in epidemiology at La Trobe University in Melbourne, said by email. “As you vaccinate more people in these trials the chances are that there will be some illnesses in participants. The only difference here is that in the world that we live in right now, the progress of these trials are in the public eye, and so we are riding every bump.”
- https://www.bloombergquint.com/onweb/j-j-confirms-covid-19-vaccine-trial-paused-on-safety-event
Pfizer Modifies Protocol for Coronavirus Vaccine Study
Drugmaker Pfizer has again modified the protocol for its late-stage study of its vaccine against the new coronavirus, this time to include more young participants. The company said on Monday that it’s received permission from the Food and Drug Administration to include adolescents aged 12 through 15 in its global Covid-19 vaccine study. New York-based Pfizer originally planned for 30,000 participants, but in September expanded that to 44,000 people.
That increase was made to boost diversity in the trial population, specifically by including 16- and 17-year-old teens, as well as stable patients with some common chronic infections: hepatitis B, hepatitis C and HIV. Pfizer’s trial also includes significant numbers of Hispanic, Black, Asian and Native American participants, plus many people aged 56 through 85. The diversity is aimed at providing information on how safe and effective the experimental vaccine is in people of different ages and backgrounds.
- https://www.deccanherald.com/business/business-news/pfizer-modifies-protocol-for-coronavirus-vaccine-study-901279.html