COVID-19: Experts seek independent review of potential vaccines as Russia distributes ‘Sputnik V’ September

*The public becoming increasingly distrustful of vaccines, as 40 percent American population say no to an approved Coronavirus vaccine even if for free ─Report  

*Any potential vaccine will be safe and effective, assures FDA

*Vaccines will be supplied first to healthcare workers, teachers for free ─Russian Health Minister

Gbenga Kayode | ConsumerConnect

While the global world expects scientists to come forth with safe and effective vaccines against the novel Coronavirus (COVID-19) pandemic soon, there are yet current concerns among regulatory authorities, healthcare professionals, and even consumers as regards when and how these should be delivered to the world in earnest.

ConsumerConnect gathered that several leading health experts and physicians are standing shoulder-to-shoulder in a rallying cry for an independent commission to review COVID-19 vaccine trial data before a vaccine is permitted on the market.

Experts fear that the mistakes government agencies have made during the pandemic could multiply and put people at further risk, report said.

The health professionals want the safeguard of an independent commission that can work independently of the US Food and Drug Administration (FDA), which still regulates vaccines and can rubber stamp its approval without a separate review, it was learnt.

As regards lack of confidence vote on vaccine, report indicates that the other bone of contention the experts are bringing up is that the public is becoming increasingly distrustful of vaccines.

Dr. Anthony Fauci, Director of National Institute of Allergy and Infectious Diseases (NIAID), United States, recently said giving emergency approval to a vaccine that has not been thoroughly tested in clinical trials is not a good idea.

Surveys by both Gallup and CNN also showed that upwards of 40 percent of the population say they won’t take an approved coronavirus vaccine even if it was free.

That lack of buy-in could make things worse by impeding efforts to get the virus under control.

It was further learnt that the idea of having an independent panel lies with Dr. Kathryn Stephenson, Harvard Medical School professor.

Dr. Stephenson told CNN that said she felt an independent commission could spur trust in a vaccine after several of her peers told her they also didn’t want to get a Coronavirus vaccine when it becomes available.

“I’m hearing this from my peers, from doctors and nurses. They’re not anti-vaxxers. They’re pro-vaccine.

“They vaccinated their own children. But they are skeptical about this vaccine.”

Similarly, bioethicist Arthur Caplan, Director of Medical Ethics at New York University (NYU) Langone Health, reached the same conclusion.

Caplan said: “We’re used to this world where if the FDA or the CDC or the NAS says something is safe and effective, that’s enough, but I don’t think this time that’s sufficient to overturn public skepticism.

“I think we desperately need an independent national commission.”

However, in spite of the rife distrust among the populace, an agency spokesperson, regarding the FDA’s take on the matter, referred reporters to a blog post in Health Affairs by FDA Commissioner Dr. Stephen Hahn and two other physicians at the agency.

These officials detailed what the agency is doing to “offer reassurance that any potential vaccine will be safe and effective,” said the spokesperson.

They said in the blog post: “First, the agency established clear recommendations for vaccine performance prior to the initiation of Phase 3 trials to provide assurance that any authorised vaccine will meet appropriate standards for safety and effectiveness.

“Second, FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”

In the meantime, Russia has said that it will begin large-scale provision of “Sputnik V”, its Coronavirus vaccine September 2020.

Mikhail Murashko, Health Minister who disclosed this Monday, August 31 said: “The vaccines will be supplied first and foremost to healthcare workers and teachers,” according to the state news agency TASS.

Russia’s Vaccine ‘Sputnik V’

Murashko stated that the vaccination “will be absolutely voluntary.”

Russia was the first country to introduce a vaccine for the novel Coronavirus that it says can be used by the general public.

About 40,000 volunteers are in a phase 3 trial of the vaccine, reports the state media.

However, it is recalled that early August this year when the country announced the production of its COVID-19 vaccine, Russia’s feat has been pooh-poohed with a healthy dose of skepticism around the world.

ConsumerConnect had reported that the time Russian health authorities after only two months of testing on 100 subjects, the equivalent of a Phase 1 clinical trial approved Sputnik V.

The country days after approval reportedly began a Phase 3 clinical trial for the vaccine, despite the fact that it has already endorsed the drug for general distribution for the use of consumers.

Incidentally, there is no published data about the long-term effects of the vaccine, report stated.

Likewise, the World Health Organisation (WHO) officials also appear somehow skeptical of Russia’s vaccine claims according to report.

The United Nations health body said that it had been in close contact with Russian health officials about the process used to approve the vaccine in the first place.

Generally, subsequent to the country’s announcement of a vaccine to combat the fatal Coronavirus indicates that there are plenty of skeptics who say “the drug is not ready for general distribution.”

But the Russian Government says it has approved a vaccine against the COVID-19 after it “proved to be safe and effective”.

Russian President Vladimir Putin made the announcement and disclosed that one of his daughters had taken it.

President Putin said the Russian vaccine is the first anywhere to be registered for general use.

President Putin said: “Although I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks.”

Although the world generally welcomed the news in August, Dr. Scott Gottlieb, former Commissioner of the United States (US) Food and Drug Administration (FDA), advised caution.

In an interview with CNBC, Gottlieb had noted that the vaccine has only been subjected to “a phase 1 clinical trial” with about 100 subjects receiving it, and that the trial was completed in “a two-month period”.

Peter Kremsner, a vaccine researcher at the University Hospital, in Tuebingen, also told Reuters that “normally you need a large number of people to be tested before you approve a vaccine.

“In that respect, I think it’s reckless to [approve it] if lots of people haven’t already been tested.”

So, as the country gears up to begin distribution of its vaccine to consumers, having been developed in a state laboratory, and tested on the lab’s workers as well as volunteer soldiers, Russia insists no substantial side effects have been reported.

Russia has recorded nearly 1 million cases of the novel Coronavirus, the world’s fourth-largest caseload.

Therefore, as authorities, health professionals and populations across the globe express concerns over the safety and efficacy of potential vaccines, consumers await production and distribution of a secure vaccine with much expectation.

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