Emergency Use authorizations for Covid-19 vaccine candidates

We are all extremely tired of the devastating health, economic and psychological consequences of the Covid-19 pandemic produced by the SARS-CoV2 virus. For the past few months, several scientific groups have been actively working in the design and preparation of vaccine candidates that will be both safe and efficacious. Recently we got very auspicious news from the Pfizer-BioNtech vaccine we had already discussed in a previous article.

On November 19, an article in The New York Times informed us that: “the drug maker Pfizer announced on Monday that an early analysis of its coronavirus vaccine trial suggested the vaccine was robustly effective in preventing Covid-19…The company said that the analysis found that the vaccine was more than 90 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. If the results hold up, that level of protection would put it on par with highly effective childhood vaccines such as measles.”

Buoyed by these highly encouraging results, the companies are already talking about getting an emergency approval with the corresponding regulatory authorities. We have already discussed in another article how the deep public distrust of vaccination could undermine the generalized acceptance and eventual efficacy of a vaccine to cut the transmission chain of the virus in public and private spaces. A big challenge.

Do we have any recent scientific experience about provisional authorizations? Yes. In a comment published in The Lancet, Maxwell J. Smith et al.—after discussing the dubious validity of the Russian and Chinese vaccines that have not met the stringent regulatory controls of the Phase III clinical trials—said: “So why have the actions of Russia and China drawn such criticism? And how can other national regulatory authorities ensure that future emergency use authorizations for Covid-19 vaccines are issued in a way that is scientifically and ethically sound? Experience for emergency use authorizations for investigational Ebola virus vaccines in Guinea and Democratic of the Congo (DRC) can elucidate key lessons that can guide ethical emergency use authorizations for Covid-19 vaccines.”

In 2016, the regulatory authorities of Guinea granted a temporary authorization for an expanded access to the recombinant vesicular stomatitis virus (rVsV) vaccine that expresses the glycoprotein of Zaire Ebola Virus (ZEBOV) which induced and immunogenic response in the affected patients. Using a World Health Organization (WHO) protocol for scientific research ethics, the vaccine was approved for the individuals exposed to the Ebola-infected patients in a national vaccination drive. In the beginning of 2017, two other Ebola vaccines that were in Phase III of clinical  trials, but that were not yet licensed, were also approved for expanded access. In 2019 the Food and Drug Administration (FDA) approved these vaccines and in 2020 the European Commission followed suit, approving their medical use.

The authors state that there are two major differences in the regulatory requirements for the emergency approval of the Ebola and Covid-19 vaccines. First of all, the emergency authorization of the Ebola vaccines was done in an extremely transparent way. “The 2013-2016 outbreaks of Ebola virus disease in West Africa prompted WHO to develop an Emergency Use Assessment and Listing (EUAL) procedure to expedite the availability of vaccines.” This was meant as a guiding manual to engage the public discussion with representative institutions, media influencers and the general public about the unavoidable trade-offs in times of extreme social danger. Would the Guinean public be willing to accept “a little bit certainty” regarding the safety parameters for the concrete possibility of accessing a life-saving tool for millions of them, including children?  These authors stated that: “it is unclear whether these Covid-19 vaccines meet WHO manufacturing quality norms and standards, including whether the benefits outweigh the foreseeable risks.”

The second key difference is the disgusting chauvinism that “has infected” the larger public discussion of the many vaccine candidates, with most developed nations with the critical capacity to conduct clinical trials and to mass manufacture the product, fighting to be “the first one” to get the product to their citizenry and insisting of having early access to a vaccine before giving it to other less endowed countries. This resembles a “war with other means” and History has taught us that the first casualty in any kind of war is always the same: Truth. This geopolitical tug of war will compromise the access of poor citizens to the vaccines, with risks for us all. Moreover, can we really trust any product if we suspect that there are dark political interests behind its emergency use authorization? Talk of fear of The Deep State

Stay distant. Stay safe. Stay beautiful.

What do you think? Please tell us.

Don’t leave me alone.