Rabbi Shmuel Herzfeld raised his arm on Monday, July 27, 2020 during a clinical trial for a coronavirus vaccine at Meridian Clinical Research in Rockville, Maryland by Dr. Disinfect Chao Wang. The coronavirus vaccine was developed by the biopharmaceutical company Moderna.
Amanda Andrade-Rhoades | The Washington Post | Getty Images
A top tier advising U.S. health officials on Tuesday predicted that four U.S.-sponsored late-stage coronavirus vaccine trials may fail to produce positive results.
The National Academies of Science, Engineering, and Medicine have released a draft report that includes a federal plan for the distribution of a coronavirus vaccine in the United States, if one is approved for public use. The vaccine would be distributed in four phases, with healthcare workers and vulnerable Americans such as the elderly and people with underlying health conditions being given it first.
The group expects all volunteers who participate in US vaccine trials, regardless of their step-by-step guidelines, to receive an approved vaccination early because "this is a typical standard for the vaccine trial protocol". The Trump administration's Operation Warp Speed is expected to support up to seven Phase 3 attempts involving 30,000 people, and it is estimated that four of them will fail.
"Four of the trials will fail and all subjects in those trials will be offered access to an approved vaccine," the group wrote in the draft report. "Three of the trials will be successful, and at a 1: 1 ratio between members of the treatment groups versus the placebo group, 15,000 participants will be offered and admitted from each of these studies assigned to placebo disease."
According to a study published in the journal Biostatistics, infectious disease vaccines have a 33.4% success rate when they pass clinical trials and regulatory approval.
In phase 3 trials, vaccines are generally given to thousands of people and tested for efficacy and safety, according to the Centers for Disease Control and Prevention.
The US invested billions of dollars in six potential vaccines as part of Operation Warp Speed last month, including from pharmaceutical companies Pfizer, Moderna and AstraZeneca, all of which have entered Phase 3 trials.
Some vaccine candidates are made prior to regulatory approval. Because of the pandemic, U.S. health officials have accelerated vaccine candidate development by investing in multiple phases of research, although it could be for free if the vaccine is ultimately not effective or safe.
U.S. health officials are optimistic they will find at least one safe and effective vaccine by the end of the year and possibly more than one by early 2021.
While there is hope that scientists will find a safe and effective vaccine, according to scientists, there is never any guarantee. They warn that questions remain about how the human body reacts when infected with the virus.
For example, scientists expect antibodies to offer some protection against Covid-19, but they can't say that for sure, as the coronavirus was first discovered about eight months ago.
Hong Kong researchers reported the first confirmed case of re-infection with Covid-19 last month, a man who was first infected with the virus in late March and then apparently re-infected with the virus 4½ months later.