Merck & Co said on Monday it would stop development of its two COVID-19 vaccines and focus pandemic research on treatments, with initial data on an experimental oral antiviral expected by the end of March. In early trials, both vaccines generated immune responses that were inferior to those seen in people who had recovered from COVID-19 as well as those reported for other COVID-19 vaccines, the company said.
“Allergic reactions to vaccines are rare but...not unheard of, and they’re seen for most vaccines,” says Jason Schwartz, an assistant professor of health policy at the Yale School of Public Health and co-chair of the Connecticut COVID-19 Vaccine Advisory Group’s Science Subcommittee. While these events need to be taken seriously and investigated, he says, “I wouldn’t anticipate [them], based on what we know right now, substantially changing or slowing the rollout of these vaccines.”
One of the world’s leading vaccine manufacturers has suffered a major setback in its work to produce a Covid-19 vaccine. The problem will push the timeline for deployment of Sanofi Pasteur’s vaccine — if it is approved — from the first half of 2021 into the second half of the year, the company said Friday. The news is not just disappointing for Sanofi and its development partner, GlaxoSmithKline, which is providing an adjuvant used in the vaccine. The companies have contracts with multiple countries, including the United States and Britain, as well as the European Union.
Major coronavirus virus vaccine trials experience halts because of isolated adverse effects. FDA Commissioner Stephen Hahn, MD affirms, “The system was designed to identify safety issues... but also ultimately to get to the right answer regarding the safety and efficacy of a therapeutic or vaccine.”
[PODCAST] This podcast starts in conversation with Yale vaccine expert Saad Omer discussing how side effects in vaccine trials can cause them to break the blinding (not knowing who has gotten vaccine and who has gotten placebo). Minor side effects such as local injection site reactions are common, but each of the major vaccine trials have had at least one volunteer with a more serious adverse effect.
With very little information about the one recent serious adverse effect in the AstraZeneca vaccine trial, NIH scientists are circumspect regarding the safey of the vaccine -- not to say that it may not be safe, but they need more information before being assured that the trial should proceed in the U.S.
AstraZeneca PLC’s chief executive said a Covid-19 vaccine it is developing with the University of Oxford could still be ready by the end of the year, despite the company pausing late-stage trials after a participant in the U.K. developed an unexplained illness.
A podcast with editors of NEJM covering how COVID-19 vaccines are being developed, discussing a recent setback of one case of a possibe neurological adverse effect, and then talking about vaccine global deployment -- how and to whom first.
With multiple SARS-CoV-2 vaccines in testing, Pfizer may be betting that positioning itself to prevail in the long run will be a better strategy than necessarily being first to market. With multiple vaccine candiates in its portfolio, one may emerge later as more efficacious than what comes first.
A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
Researchers and companies developing Covid-19 vaccines are taking new steps to tackle a longtime challenge: People who need the vaccines most urgently, including Blacks and Latinos, are least likely to participate in clinical trials to determine whether they work safely.
Almost daily, President Trump and leaders worldwide say they are racing to develop a coronavirus vaccine, in perhaps the most urgent mission in the history of medical science. But the repeated assurances of near-miraculous speed are exacerbating a problem that has largely been overlooked and one that public health experts say must be addressed now: persuading people to actually get the shot.
There’s a good chance the coronavirus will never go away. Even after a vaccine is discovered and deployed, the coronavirus will likely remain for decades to come, circulating among the world’s population. Experts call such diseases endemic — stubbornly resisting efforts to stamp them out. Think measles, HIV, chickenpox.