Tag Archives: covid-19 vaccine

India’s first Nasal Vaccine against COVID- 19 gets nod for emergency use

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Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) has announced approval from DCGI for emergency use authorization first of its kind intranasal COVID-19 Vaccine to Bharat Biotech (BBIL).

Supported by DBT and BIRAC under the aegis of Mission COVID Suraksha, the mission was launched by DBT and implemented by BIRAC to reinforce and accelerate COVID-19 vaccine development efforts. Scientific leadership at various levels of vaccine development was provided by DBT laboratories and BIRAC. This is the fourth success story for the Covid-19 vaccine under mission Covid Suraksha.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. It consists of a replication deficient ChAd vector expressing the stabilized Spike SARS-CoV-2 (Wuhan variant).

DBT’s Autonomous Institute, National Institute of Immunology (NII), New Delhi utilized their “Human Immune Monitoring and T-cell Immunoassay Platform” to examine the vaccine-induced SARS-CoV-2-specific systemic and mucosal cellular immune responses the trial participants.

Interactive Research School for Health Affairs (IRSHA), Pune completed the Plaque Reduction Neutralization Assay (PRNT) to quantify the neutralizing antibody for the virus from three trial sites.

Covid Suraksha

Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, BIRAC speaking on the subject said that “The Department through Mission COVID Suraksha, is committed to the development of safe and efficacious COVID-19 vaccines.

BBV154 COVID Vaccine is the first intranasal vaccine approved by DCGI for primary immunization against COVID-19 in the 18+ age group for restricted use in emergency situation being developed in the country under Mission COVID Suraksha and adds to India’s COVID-19 vaccine series.

“This is an excellent example of Aatmanirbharta initiative of the Government of India. I congratulate our scientists for partnering with Bharat Biotech and providing scientific leadership throughout the development of first intranasal COVID-19 vaccine,” said Gokhale.

Russia completes Phase III trials, gets ready to first vaccinate doctors in October

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Despite apprehensions on the sample numbers of human trials, Russia is preparing a mass vaccination campaign against the novel coronavirus in October, after a vaccine completed clinical trials including Phase III trial on Saturday, August 1, 2020.

Health Minister Mikhail Murashko said the Gamaleya Institute, a state research facility in Moscow, had completed clinical trials preparing the required paperwork to register it, Interfax news agency reported. First to be vaccinated will be the frontline workers, doctors and teachers.

“We plan wider vaccinations for October,” Murashko was quoted as saying. Russia’s first potential COVID-19 vaccine is likely to apply for regulatory approval in August. As of Saturday, Augutst 1, 2020, Russia reported 95 new deaths from the novel coronavirus, taking its total to 14,058 out of a total 845,443 cases.

Russian vaccine

As already reported, the Gamalei Institute of Epidemiology and Microbiology had been working on an adenovirus-based vaccine at a lighting speed and announced its Phase III trials on June 18. The Sechenov First Moscow State Medical University to conduct and complete the trails of the vaccine.

The clinical trials had been conducted on volunteers by the Institute for Translational Medicine and Biotechnology of the Unviersity and the first group of volunteers were discharged on 15 July and the second on 20 July.

The head of the Russian Direct Investment Fund, Kirill Dmitriev, took pride in claiming Russia’s success in developing a vaccine the same way erstwhile Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite. Despite questions raised by some Western media whether Moscow is putting national prestige before safety.

More than 100 vaccines are being developed around the world against the COVID-19 pandemic but only four are in final Phase III human trials, according to World Health Organization (WHO) data, including three developed in China and another in Britain. The vaccine developed by Russia is not among them.

Other Vaccines

Elsewhere, Gilead Sciences, Oxford University’s researchers and American biotech company Moderna are at the forefront of developing a Covid-19 vaccine, while a Canadian and Chinese joint project is equally pushing the date for completion of clinical trials.

 

 

Not China, but Russia announces world’s first Covid-19 vaccine

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Any Covid-19 vaccine? All nations and the entire world humanity was eagerly awaiting the precious announcement from at least one top nation that its scientists have successfully completed clinical trials of Covid-19 vaccine.

When expectations were running high that it would be China, where the novel coronavirus had its origin in the city of Wuhan, unexpectedly Russia has announced first to the world that its clinical trials are completed successfully and the vaccine is ready for production.

The Sechenov First Moscow State Medical University is the one which has claimed that it has successfully completed the trails their vaccine has all the “safety of those vaccines that are currently in the market.”

Announcing the news, Vadim Tarasov, the director of the Institute for Translational Medicine and Biotechnology of the Unviersity said the clinical trials have been conducted on volunteers, reports Russian news agency Sputnik, adding that the first group of volunteers would be discharged on 15 July and the second on 20 July.

Russian vaccine

The vaccine was produced by Russia’s Gamalei Institute of Epidemiology and Microbiology on June 18. “Sechenov University has successfully completed tests on volunteers of the world’s first vaccine against coronavirus,” Tarasov said.

“The safety of the vaccine is confirmed. It corresponds to the safety of those vaccines that are currently on the market,” said another scientist Alexander Lukashev, director of the Institute of Medical Parasitology, Tropical and Vector-Borne Diseases at Sechenov University.

“Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research center that is able to participate in the creation of such important and complex products as drugs,” Tarasov said.

Elsewhere, Gilead Sciences, Oxford University’s researchers and American biotech company Moderna are at the forefront of developing a Covid-19 vaccine, while a Canadian and Chinese joint project is equally pushing the date for completion of clinical trials. BioNTech SE and Pfizer Inc’s Covid-19 vaccine candidate is expected to be ready by the end of 2020.

Coronavirus vaccine by October end, announces US pharma giant Pfizer

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American pharmaceutical giant Pfizer has announced that its ongoing development of a COVID-19 vaccine could be ready in five months period by October end. Pfizer is working on the vaccine project in collaboration with German firm Biontech.

Pfizer and its vaccine development German partner BioNTech announced on Friday, May 29, that the first participants have been given the doses in the US in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. “If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can have a vaccine around the end of October,” said Pfizer CEO Albert Bourla.

The trial is part of the dosing of the first cohort in Germany that was completed last week. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates under study. The dose level escalation portion (Stage 1) of the Phase 1/2 trial in the U.S. will enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age). The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age, said the company.

Older adults will be immunized with a given dose level once testing and dose level in younger adults has provided initial evidence of safety and immunogenicity. Currently,the participants are being given these doses at NYU Grossman School of Medicine and the University of Maryland School of Medicine, with the University of Rochester Medical Center/Rochester Regional Health and Cincinnati Children’s Hospital Medical Center.

“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary and further demonstrates our commitment to dedicating our best-in-class resources, from the lab to manufacturing and beyond, in the battle against COVID-19,” said Albert Bourla, Chairman and CEO, Pfizer.

Pfizer and BioNTech’s Vaccine Program

Pfizer and BioNTech’s development program includes four vaccine candidates, each representing a different combination of mRNA format and target antigen. The ongoing trial allows for the evaluation of the various mRNA candidates simultaneously in order to identify the safest and potentially most efficacious candidate in a greater number of volunteers.

“It is encouraging that we have been able to leverage more than a decade of experience in developing our mRNA platforms to initiate a global clinical trial in multiple regions for our vaccine program in such a short period. We are optimistic that advancing multiple vaccine candidates into human trials will allow us to identify the safest, most effective vaccination options against COVID-19,” said CEO and Co-founder of BioNTech, Ugur Sahin, whose firm will provide the vaccine from its GMP-certified mRNA manufacturing facilities in Europe.

Once this stage is successfully accomplished, both Pfizer and BioNTech plan to rapidly increase production of millions of vaccine doses in 2020, increasing to hundreds of millions in 2021. BioNTech and Pfizer will work supply the vaccine worldwide once regulators allow except China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization.

Pfizer-owned sites in three U.S. states (Massachusetts, Michigan and Missouri) and Puurs, Belgium are being pressed into  manufacturing COVID-19 vaccine production, with more sites to be selected once the vaccine rolls out. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech plans to ramp up its production capacity.