NATIONAL, 6 SEPTEMBER, 2020 (GPN) : In USA some of the Top vaccine developers, including Pfizer Inc, Johnson & Johnson and Moderna Inc, plan to issue a public pledge not to seek government approval until their vaccine candidates are proven to be safe and effective, the Wall Street Journal reported on Friday.

The companies would pledge to adhere to high scientific and ethical standards in the conduct of clinical studies and in their manufacturing processes, the Journal report said, citing the draft of a joint statement that is still being finalized.

The news comes amid rising concerns that political pressure ahead of the Nov. 3 election could weigh on the safety and effectiveness of a potential vaccine for the respiratory illness.

White House Press Secretary Kayleigh McEnany said on Thursday that even though the stakes are high for President Donald Trump, who is squaring off against former Vice President Joe Biden, there is no political pressure on the U.S. health regulator to quickly approve a vaccine.

AstraZeneca Plc, Pfizer and Moderna are among those farthest along in the race to develop vaccines to prevent COVID-19 infection or limit its severity, with their candidates in late-stage clinical trials.

Much like how a lot of places require negative COVID certificates from people, proof of vaccination will deem them fit and healthy. However, vaccination cannot be forced on people.

Past vaccination programs have also worked by delivering incentives for the ones who get themselves vaccinated. In the future, a plan like this could be explored to drive high numbers in the public to get vaccinated. Of course, vaccine delivery and doses will need to be reserved and effective distribution plans will have to be devised.

In India Bharat Biotech, in partnership with the Indian Council of Medical Research, began research on the first homegrown COVID-19 vaccine in the country a few months ago. The vaccine was currently in the phase 1 trials, being conducted at several locations around the country.

According to a report by the news agency, the stage for phase 2 trials of Bharat Biotech’s Covaxin, is now ready, and the trials may begin tomorrow on Monday.

The Hyderabad-based vaccine company has received approvals from the Central Drug Standard Control Organisation, under the Directorate General of Health Services to conduct the trials, the news agency reported.

The approval was given in the form of a letter written by Joint Drugs Controller Dr S. Eswara Reddy to Bharat Biotech.

The phase 2 trials of BBV152, also dubbed as Covaxin, will reportedly be conducted on 380 participants, who will have to be screened four days after the vaccine is administered to them. the Joint Drugs Controller said that the directorate had no objection to conducting the trial to evaluate the safety, reactogenicity, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy volunteers’.The letter mentions that Bharat Biotech’s request for approval to initiate phase II clinical trials was examined in consultation with the Subject Expert Committee (COVID-19) experts held through virtual meeting on September 3.

“This is to inform you that the subject proposal was examined in consultation with SEC (COVID-19) experts held through virtual meeting on 03-09-2020, wherein the committee recommended for the conduct of Phase II part of clinical trials with 380 participants subject to the condition that time for screening the participants should be revised to 4 days,” reads the letter dated September 3.

Trials conducted so far
Phase 1 trials for Covaxin began on July 15 at 12 centres across the country. Healthy individuals were given two doses of the vaccine, with a gap of about 14 days. The phase 1 trials were conducted on over 350 people, and are still continuing.

In phase 1 trials, the volunteers were examined after every two days. The period will be extended to 4 days in phase 2 clinical trials.

Despite being one of the top producers of vaccines and advanced player in medical know-how, India still ranks low on immunization. 1/3rd of Indian children are not immunized by choice, according to an NCBI study. Adult vaccination rates and awareness is also low in the country.

Factors like these could make the spread of the pandemic even worse in the country. With increased reports of growing anti-vaxxers news making waves in India, in scrupulous ways, fears loom large about the many factors we haven’t still taken into consideration about a COVID vaccine yet.While vaccines for children are made compulsory in many regions, the same mandate isn’t widespread for adults. If there exists a possibility that some adults actually reject a COVID vaccine, it may fail the objective of inoculation against the pandemic- which would only mean that certain individuals would continue to be susceptible to the infection and even risk transmission. Multiply the odds of this happening in large population sizes.

The large-scale global distribution of vaccines against Covid-19 is not expected until mid-2021, the World Health Organization’s (WHO) chief scientist Dr Soumya Swaminathan had said earlier in a media briefing.

Russia Claims their Vaccine is Authorised for use amid Phase 3 Trials which will be conducted on 40000 volunteers.Russian Defence Minister Sergei Shoigu has been inoculated with the country’s covid vaccine, Sputnik News reported, citing the Defence Ministry. The defence minister has said that he feels good after being inoculated with the coronavirus vaccine and experiences no side effects, news reports said.

He joins some top leaders of the country who got themselves inoculated with Sputnik V covid vaccine. Leader of the Liberal Democratic Party of Russia Vladimir Zhirinovsky has been injected with the covid vaccine developed in Russia, a party leader told GPN.

Sputnik News also reported that Russian Trade Minister Denis Manturov had been inoculated with the Russian vaccine Sputnik V.

Russia licensed the two-shot jab for domestic use in August, the first country to do so and before any data had been published or a large-scale trial begun.

Russian President Vladimir Putin had claimed that one of his daughters had been inoculated with the vaccine.

On August 11, Russia became the first country to license a COVID-19 vaccine, calling it “Sputnik V” in homage to the world’s first satellite, launched by the Soviet Union. But western experts have warned against its use until all internationally approved testing and regulatory steps have been taken. The vaccine is undergoing Phase 3 trials.

Russia’s “Sputnik-V” COVID-19 vaccine produced an antibody response in all participants in early-stage trials, according to results published on Friday by The Lancet medical journal that were hailed by Moscow as an answer to its critics.

The results of the two trials, conducted in June-July this year and involving 76 participants, showed 100% of participants developing antibodies to the new coronavirus and no serious side effects, The Lancet said

Russia licensed the two-shot jab for domestic use in August, the first country to do so and before any data had been published or a large-scale trial begun.

China on the other hand claims of developing two successful Vaccine but since it is cut off from rest of the world either it’s authenticity is not know or nobody is interested to know as the Chinese have been the cause of Covid-19 Pandemic. ENDS