India gets 4th covid-19 vaccine soon: Pfizer-BioNTech COVID-19

Pfizer is in discussions with the Indian government to come up with a pathway to secure an expedited approval for its Pfizer‑BioNTech COVID‑19 Vaccine (also known as BNT162b2) under revised regulations, the company’s chief executive officer Albert Bourla said on Monday while announcing a donation of medicines worth $70 million to fight the resurgent pandemic.

The medicines include steroid medications to reduce inflammation, anticoagulants to help prevent blood clotting, and antibiotics to treat secondary bacterial infections, he said.

However, under schedule Y of the Drug and cosmetic act 1940, Rules 1945, even under the new norms, vaccines that are eligible for use in India will have to start a local bridging trial within 30 days of getting the authorization. They will also have to conduct a safety review for the first week on 100 vaccines before mass rollout.

Pfizer was the first company to apply for emergency authorization for its vaccine in India. However, due to lack of adequate data on the local population, the subject expert committee of the Indian regulator asked the pharmaceutical giant to conduct a local bridging study to prove that the messenger RNA vaccine, the latest technology in vaccine technology, was similarly safe and effective in the Indian population as it was in the US, where a majority of its global trial was conducted.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

In a statement on 23 April, Pfizer said that it has offered to supply its vaccine to the Indian government at a “not-for-profit” price as part of its strategy to provide distinct prices for the vaccine based on the economic profile of the country.

The Pfizer vaccine that was developed by a German company, BioNTech, and Moderna’s vaccine are not suited for wide use in developing countries as they have to be stored at extremely cold temperatures.

Several other Indian companies are also developing vaccines indigenously, listed below.

COVID-19 VACCINES UNDER TRIALS IN INDIA

  1. ZyCov-D
  2. Biological E’s novel Covid-19 vaccine
  3. BBV154 – Intranasal vaccine
  4. COVOVAX
  5. mRNA based vaccine (HGCO19)

ZyCoV-D

ZyCogrfgV-D

Zydus Cadila, focused on discovering and developing NCEs, Novel Biologicals, Biosimilars and Vaccines, announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D. Safety in Phase I clinical trial of ZyCoV-D in healthy subjects established as endorsed by the independent Data Safety Monitoring Board (DSMB). Zydus commenced Phase II trial.

  • DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
  •  Phase I Human Clinical Trial COMPLETED
  •  Phase II Human Clinical Trial COMPLETED
  •  Phase III Human Clinical Trial ONGOING
  •  DCGI approval for Phase III Human Clinical

Biological E’s novel Covid-19 vaccine

Biological E. Limited is conducting a prospective open label randomised Phase-I seamlessly followed by Phase-II study to assess the safety, reactogenicity and immunogenicity of Biological E’s novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for protection against Covid-19 disease when administered intramuscularly in a two dose schedule(0, 28D) to healthy volunteers.

  • DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
  •  Phase I/II Human Clinical Trial ONGOING

BBV154 – Intranasal vaccine

Bharat Biotech is conducting Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. BBV154 is an intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses.  Immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of COVID-19.

  •  DCGI approval for Phase I Human Clinical Trials RECEIVED
  •  Phase I Human Clinical Trial ONGOING.

COVOVAX

Indian Council of Medical Research and Serum Institute of India jointly performing a phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults.

  •  DCGI approval for Phase 2/3 Human Clinical Trial RECEIVED
  •  Phase 2/3 Human Clinical Trial ONGOING

mRNA based vaccine (HGCO19)

Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects. The trial is being conducted by Gennova Biopharmaceuticals Limited.

  • DCGI approval for Phase I/II Human Clinical Trial RECEIVED
  •  Phase I/II Human Clinical Trial ONGOING.

Bibliography: Indian Council of Medical Research (ICMR).

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