• The Financial District


Researchers from China have published results about the safety and efficacy of a whole-virus vaccine. The vaccine triggers an immune response, and side effects were rare and mild, Mihai Andrei wrote for ZME Science on August 16, 2020.

The new vaccine, developed by researchers at Sinopharm, a unit of China National Pharmaceutical Group, is the first to use a protein immunogen. Essentially, it’s a whole-virus inactivated COVID-19 vaccine, a different approach from what other advanced candidates are doing. “The so-called genetic immunization candidate vaccines, including messenger RNA, DNA, and non-replicating viral vectors such as recombinant adenovirus, were the first vaccine candidates to report interim results of early-phase clinical trials because these platforms are preexisting, flexible, rapid, and scalable. Therefore, genetic immunization approaches are particularly suited to a rapid pandemic response,” writes Mark J. Mulligan, professor at the NYU Grossman School of Medicine, in a commentary article on the new vaccine.

Protein immunogens are a different, more traditional category of vaccines, Mulligan explains. The polio vaccine is the classic example of this type of approach, and it’s a well-trodden path in regards to vaccine development. The Sinopharm trials consisted of 2 randomized placebo-controlled trials. In the phase 1 trial, 96 healthy adults were administered low, medium, and high vaccine doses, three times: on day 0, day 28, and day 56. Side effects were reported in 20.8%, 16.7%, and 25.0% of cases respectively, but the main side effects were mild: injection site pain and fever.

The placebo group (which received a non-vaccine injection) also reported side effects in 12.5% of cases overall, indicating that the vaccine itself only causes mild side effects in a minority of cases. The good health of participants was assessed through self-reports as well as blood tests. The study was published in the Journal of the American Medical Association (JAMA).

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