Given that more than 200,000 Americans have died (at least in part) due to COVID-19, there seems little to lose and much to gain by green lighting human challenge trials in which volunteers are vaccinated and then deliberately infected with coronavirus. The U.S. should follow the UK's lead.
It is difficult to overstate the potential damage that an ineffective or unsafe coronavirus vaccine could inflict on confidence in public health institutions. Conspiracy theories already abound and would multiply further.
The University of Oxford, in collaboration with British pharmaceutical firm AstraZeneca, has produced a leading coronavirus vaccine candidate. However, the Phase 3 clinical trial was paused because one patient is thought to have developed a serious adverse reaction. What could it be?
Are vaccines going to be adequately tested for safety and efficacy if Phase 3 clinical trials are not completed? Does convalescent plasma work to treat COVID? Is the COVID death toll inflated? We attempt to clarify these controversies.
FDA Commissioner Stephen Hahn indicated that his agency would be willing to grant emergency authorization to a coronavirus vaccine, even before it completes Phase 3 clinical trials. This is a reckless gamble and could cause an unmitigated public health disaster.
Large pharmaceutical companies are multinational organizations with incentives to distribute their vaccines broadly.
Bill Gates, perhaps the greatest philanthropist the world has ever known, has become the target of unhinged, self-contradictory conspiracy theories that are disturbingly popular.
A very disturbing paper published in The Lancet Infectious Diseases proposes that vaccines can have unexpected side effects. Some are good, such as protecting against unrelated diseases, while some are bad, such as increasing all-cause mortality. This is highly useful and potentially life-saving information that must not be hijacked by anti-vaxxers.
The coronavirus has mutated to become more infectious. Does that mean it will become more or less lethal? And what implication does it have for a vaccine and herd immunity?
Vaccines for COVID-19 get most of the headlines. But it is possible, if not likely, that a drug or combination of drugs may be quicker to develop, and possibly will be more effective in controlling the virus. Here's an opinion piece making the case that recently ran in the Baltimore Sun, co-authored by ACSH's Dr. Josh Bloom and ACSH advisor Dr. Katherine Seley-Radtke.
The FDA’s rigorous oversight – rather than a race to satisfy an aggressive agenda – is imperative during this pandemic.
Most drug and vaccine candidates fail. However, the success rate varies wildly depending on the therapeutic area. The probability that at least one coronavirus vaccine will win FDA approval is quite high, though that does not mean it will work well.