J&J and Novavax seek approval for vaccines

Two coronavirus vaccine makers, Johnson & Johnson (J&J) and Novavax, announced that they have approached the Indian drugs regulator for emergency approval of their products, raising the possibility of large quantities of doses becoming available over the next months as the country races to inoculate more people to stave off a third wave of Covid-19.

Both of the companies have partnered with Indian vaccine manufacturers: Pune-based Serum Institute of India is producing and carrying out trials for Novavax, and Hyderabad-based Biological E is producing doses for J&J.

The J&J vaccine has been approved by several western countries and is in use in many of these, while the Novavax dose has shown some of the most promising results in clinical trials.

“On 5th August 2021, Johnson & Johnson Pvt Ltd applied for emergency use authorisation (EUA) of its single-dose Covid-19 vaccine to the government of India. This is an important milestone that paves the way to bringing our single-dose Covid-19 vaccine to the people of India, and the rest of the world, through a collaboration with Biological E Limited,” the company said in a statement.

Novavax too issued a statement, saying: “Novavax Inc, with its partner, Serum Institute of India Pvt Ltd (SII), today announced that the companies have filed regulatory submissions for emergency use authorisation of recombinant nanoparticle protein-based Covid-19 vaccine candidate. The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines”.

The Novavax vaccine showed an efficacy rate of 90% in clinical trials but is yet to be approved for emergency use in any country.

The J&J vaccine, which has shown 66-72% efficacy in different trials, has been approved by regulators in the US, UK, Europe and the World Health Organization. The company in May applied for a permission to carry out bridging trials – smaller clinical trials that are meant to assess if the findings are similar to larger trials carried out elsewhere. But it withdrew the request last week and filed for emergency approval directly, making use of a change in policy in India that allows coronavirus vaccine makers to do so if they have received approvals by certain regulators around the world.

The statement said J&J looked forward to concluding its discussions with the government of India to accelerate availability of its Covid-19 vaccine to help end the pandemic.

Experts said J&J’s single dose vaccine could help vastly improve availability. “Yes, single dose vaccine works better; we may need a booster later, but it’s a great addition,” said Dr Gagandeep Kang, senior vaccine expert, from CMC Vellore.

Representatives of both the vaccine makers’ Indian partners also met top Indian officials on Friday.

Union health minister, Mansukh Mandaviya, on Friday met the managing director of Biological E, Mahima Datla, although the two discussed Corbevax, the other coronavirus vaccine Biological E is developing. This dose is in collaboration with the Baylor College of Medicine in Texas.

“Met Ms Mahima Datla, MD of @Biological_E, who briefed me on the progress of their upcoming #COVID19 vaccine, Corbevax. I assured all the Government support for the vaccine,” the health minister tweeted.

SII chief executive Adar Poonawalla too met Mandaviya as well as Union home minister on Friday. Poonawalla, news agency PTI reported, later said that he expects Covavax (the Novavax dose made by it) to become available for adults by October and for children by the first quarter of next year if all regulatory processes proceed as planned.

“…hopeful that for adults Covovax will be launched in October, depending on DCGI approvals… The Covovax vaccine for kids will be launched in the first quarter of the next year most likely in January-February,” news agency PTI quoted Poonawalla as saying following the meeting.

Novavax, in its statement, said it and SII have completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the review, including preclinical, clinical, and chemistry, manufacturing and controls data.

“Today’s submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax transformation into a commercial global vaccine company,” said Stanley C Erck, president and chief executive officer, Novavax