Coronavirus vaccine: These Indian, US firms have entered last stage of clinical trials

The race to develop a safe and effective COVID-19 vaccine is well underway as the world continues to grapple with the coronavirus pandemic. There are dozens of coronavirus vaccines in development, primarily in the phase 2/3 clinical trials in the US as well as in India. There are four US-based companies whose vaccine candidates have moved into the crucial phase-3 development phase. This includes--Pfizer, Moderna, Johnson & Johnson, and Novavax. Whereas in India, at least seven pharma companies are working to develop a vaccine against coronavirus.

The first and second phases of clinical studies are primarily conducted to test for safety, while the third and final stage is used to determine whether vaccines are efficacious and can prevent infection among participants.

Coronavirus vaccines in phase-3 trials in the US

1.Pfizer

Pfizer and BioNTech's mRNA-based vaccine from its BNT162 programme has emerged as a frontrunner in the race for a COVID-19 vaccine. Pfizer is planning to announce the final data about its vaccine next month. The US pharma major has reached a deal with German contract manufacturer Rentschler Biopharma to handle the downstream purification process for the pair's mRNA-based COVID-19 vaccine.Pfizer has received $1.95 billion in manufacturing funding from the US government. It has promised to provide 100 million doses, with an option to buy up to 500 million more doses to US citizens.

2. Moderna Inc

Another US pharma major Moderna Inc's vaccine candidate is among those undergoing large-scale phase-3 clinical trials in the United States, in which 30,000 participants are being enrolled.

The company has recently said that the effectiveness of its coronavirus vaccine will be known by November. Moderna has never made a vaccine that has been approved. For coronavirus, it is using mRNA approach that has never produced a successful vaccine for any disease. Moderna has received up to $1.525 billion of supply funding from the US government.  

3. Johnson and Johnson

American drugmaker Johnson and Johnson said on September 23 that it was planning to enroll up to 60,000 people in the late-stage clinical trial of its coronavirus vaccine Ad26.COV2.S or JNJ-78436735.

Johnson & Johnson recently concluded a deal with the European Union to supply up to 400 million doses of its potential COVID-19 vaccine. The J&J vaccine, which is being developed by its subsidiary, Janssen, is based on vector technology, the same used by UK's AstraZeneca and France's Sanofi.

Johnson and Johnson has promised 100 million doses with the option to buy up to 200 million additional doses for US citizens.

4. Novavax

US biotechnology form Novavax has started phase-3 efficacy trials of coronavirus in Britain to evaluate the safety and immunogenicity of Novavax's COVID-19 vaccine candidate--NVX-CoV2373.

The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2 degree Celsius to 8 degree Celsius, allowing for distribution using standard vaccine channels.

Meanwhile, in India,  Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.

Bharat Biotech, which had sought Drugs Controller General of India's nod for conducting phase-3 clinical trials of its COVID-19 vaccine candidate, has been asked to first submit complete safety and immunogenicity data of the ongoing phase-2 trial. Its vaccine candidate - 'Covaxin' - is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).

The Serum Institute of India (SII), the world's largest vaccine maker by volume, is working on several vaccine candidates for the novel coronavirus, including Oxford University's Jenner Institute and AstraZeneca. At present, it is in the final stage of the human clinical trials at 17 sites in the country.

On the other hand, phase-2 trials of Zydus Cadila's indigenous vaccine ZyCoV-D is underway. It is waiting to receive approvals for Phase 3 clinical trials for its vaccine.

Others like Panacea Biotec, Mynvax and Biological E are also working to develop vaccines for COVID-19.

Also read: COVID-19 vaccine: Bharat Biotech asked to provide complete data of phase 2 trials

Also read: Vaccine maker AstraZeneca may consider 'non-profit pledge' till July 2021 only