Vaccine had made a profound impact on human health and have been the reason for the eradication of small pox, measles and polio. However to be safe and effective, vaccines must be administered to large population before concluding it as efficacious as it’s of preeminent concern to curb the disease.
There’s no assurance that any of the vaccines being manufactured now will succeed. Among various categories Anti-infective drugs, including vaccines, have higher chances of being approved than other categories, however the failure rate is still high.
As per the statistics, drugs in Phase I trials have only a 10% success rate, while vaccines may have close to 22%. Drugs in Phase III trials have a 62% success rate, which indicates that approximately 40% of those drugs fail during the approval process.
Scientists are eyeing to bring success by working with multiple platforms to target the SARS-CoV-2 virus. Seven approaches are currently being used: DNA, RNA, inactivated virus, live attenuated virus, non-replicating viral vectors, replicating viral vectors and protein subunits.
This implies that public could have an option to choose the type of COVID-19 vaccinations, where some of these may be more effective than others. The Centre for disease control and prevention (CDC) defines “effective” as “preventing medical outpatient visits.” CDC reports that the seasonal flu vaccines are typically about 50% effective, where the recent flu vaccine in 2018-19 was just 30% effective.
In April 1955, 2,00,000 children in five Western and mid-Western USA on receiving polio vaccine reported paralysis within few days and soon the first batch of mass production program was prohibited within a month. Further investigations started that vaccine inoculation, developed by the California-based family company `Cutter Laboratories’, had triggered 40 000 cases of polio, resulting in iatrogenic paralytic polio among 200 children that also killed 10 individuals despite not being negligent.
Cutter followed all guidelines according to the protocol in the production of the vaccine and only released that passed safety rests. Nevertheless, the vaccine rather than supposedly preventing, had caused polio instead due to the presence of live polio virus unfortunately in what was supposed to be an inactivated virus vaccine. In this way the cutter incident has remained as one of the worst pharmaceutical disasters in American history.
Of late Russia stated that it has produced the first batch of its coronavirus vaccine after President Vladimir Putin announced they were the first in the world to get the approval for the vaccine Sputnik V developed by Gamaleya research.
The vaccine still in the pipeline to complete final trials, raising concerns among experts at it’s fast tracked approval.
Russia has not yet published any scientific data from its first clinical trials. The WHO enlists Russia’s Sputnik V still in first stage of clinical trials. However, the vaccine’s approval by the Russian health ministry comes preceding the third stage of trials.
Former FDA Commissioner Scott Gottlieb asserted that he would deny the vaccine outside of a clinical trial because it seemingly appears to have been tested in just several hundred patients at most. The vaccine should reach the final stage and get safety approvals from FDA.
Reportedly vaccine trials from other nations have been open. Last month, scientists published encouraging early-stage results on three vaccine candidates, including one being developed by the NIH and Moderna Inc, which is the first U.S. COVID-19 vaccine to enter phase 3 trials. At Oxford University in the U.K. two vaccine inoculations and in Wuhan, China, also have produced great results in early-stage trials.
United nation’s health agency spokesman Tarik Jasarevic said they are in close contact with Russian authorities in regard to pre qualification by WHO. Lawrence Gostin, a global public health law expert at Georgetown university proclaimed that Russia is hurriedly proceeding unmindful of the safety and efficacy and asserted that trials have to be thoroughly completed. Hence from the data available from the history and from the experts opinion, it clearly indicates that the first batch of covid-19 vaccine may not always be successful that could result in failures raising safety issues.