Two vaccines, Merck drug cleared for emergency use amid Omicron rise

150 mn doses of Corbevax, Covovax expected monthly from March

India’s drug regulator approved two new Covid-19 vaccines, along with an oral antiviral pill, on Tuesday, a day after the subject expert committee (SEC) gave its green signal. Vaccines Corbevax (Biological E) and Covovax (Serum Institute of India and Novavax), and antiviral Molnupiravir (Merck and Ridgeback) were given the nod.

The move also increases the options before India to allow the mixing of vaccines for a third shot, in case the health minstry decides to do so. The Centre had recently allowed a third shot after nine months of the second dose to health care, frontline workers, and senior citizens with co-morbidities. Vaccination for 15-18-year-olds has also been opened up. Together, monthly production of 150 million doses of the two new vaccines is expected from March.

Corbevax, produced by Biological E, is India’s first indigenously developed receptor-binding domain protein subunit vaccine. The nanoparticle vaccine, Covovax, will be manufactured by Pune-based SII. Molnupiravir, an antiviral drug, will be manufactured in the country by 13 companies for restricted use under emergency situations for treatment of adult patients with Covid-19 and who have a high risk of progression of the disease.

Health Minister Mansukh Mandaviya tweeted: “Further strengthening the fight against Covid-19, CDSCO, @MoHFW_INDIA has given 3 approvals in a single day for: - CORBEVAX vaccine - COVOVAX vaccine - Anti-viral drug Molnupiravir for restricted use in an emergency situation.”

Both vaccines have been approved for adults; paediatric trials of Covovax are on. Therefore, the vaccine could be approved for use in children later.

Corbevax is developed with Dynavax’s CpG1018 adjuvant with alum, which helps the body build immune response against coronavirus, said Biological E. It has developed the vaccine in collaboration with the Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine in Texas.

The vaccine has completed two phase 3 clinical trials involving more than 3,000 subjects (18-80-year-olds) across 33 sites in India. The firm claimed in the pivotal phase 3 study conducted with an endpoint of immunogenic superiority, Corbevax showed superior immune response in comparison with Covishield when assessed for neutralising antibody (nAb) titres against the original Wuhan-strain and the Delta variant of the Sars-CoV-2 virus.

The firm added that Corbevax is more than 90 per cent effective in preventing symptomatic infections against the Wuhan strain; against the Delta strain, it indicates the efficacy of over 80 per cent. Subjects who took Corbevax had 50 per cent fewer adverse events than Covishield, Biological E claimed. None who received either of the vaccines had any serious adverse events.

Further, the Hyderabad-based vaccine maker said Corbevax showed a 30 per cent decline in nAb until six months of the second dose, compared to an over 80 per cent drop observed with the majority of the approved vaccines.

Mahima Datla, MD, Biological E, noted: “Covid Suraksha Programme’s endeavour to accelerate vaccine development played a crucial role in the initial development; the mechanism that was set-up with the support of the Department of Biotechnology and the Biotechnology Industry Research Assistance Council allowed us to scale up to a capacity of about 1.2 billion doses per annum, making the dream of accessibility – affordability and supply — a reality.”

Novavax’s nanoparticle vaccine, on the other hand, is developed with Matrix-M adjuvant, and it already has approvals from the WHO, Indonesia, and the Philippines.

Adar Poonawalla, CEO of SII, which will make and market the vaccine under the name Covovax in India, said: “We are proud to deliver a highly-effective protein-based vaccine of over 90 per cent efficacy rate, based on the clinical data demonstrating a favourable safety profile.”

Novavax president and CEO Stanley C Erck said: “Novavax and our partner, Serum… will not rest in our work to deliver our vaccine to those in India and across the globe.”

Additionally, Novavax and SK Bioscience announced a Biologics License Application submission in South Korea. Novavax expects to submit the complete package to the US FDA by the end of the year.

Roll-out timelines

Biological E plans to complete production at a rate of 75 million doses per month, anticipating over 100 million doses per month from February 2022, the company said. It aims to deliver 300 million doses to the Indian government soon.

The Centre had placed advance orders for 300 million doses of Corbevax with Biological E with a payment of Rs 1,500 crore in June. The government had not revealed the price at which the advance order was placed with the company.

“Soon, the company plans to deliver more than one billion additional doses globally,” it added.

SII did not comment on vaccine production plans and volumes.

Sources, however, said the company may touch production volumes of 50 million monthly doses of Covovax by March. Poonawalla had indicated there were raw material availability issues for this vaccine around April this year.

A Novavax spokesperson had recently indicated to Business Standard that “Novavax is expecting to produce approximately 2 billion doses in 2022 across the global manufacturing network”.