Biological-E COVID vaccines in India soon, government seals deal for 300 million doses

NEW DELHI: In order to strengthen the fight against the coronavirus, the Government of India has signed a deal for 300 million doses of Biological-E COVID vaccines.

According to sources, the government has signed the deal with domestic vaccine maker Biological-E for 300 million COVID-19 vaccine doses for 15 billion rupees (USD 205.62 million).

The vaccine, which is currently undergoing phase-3 clinical trials, is likely to be available in the next few months, the Health Ministry has said in a statement.

According to a Reuters report, Hyderabad-based Biological E Limited has signed a deal with Canadian biotechnology company Providence Therapeutics Holdings Inc for its COVID-19 vaccine. 

The vaccine being developed by Biological-E in collaboration with the Canadian biotechnology company is an RBD protein sub-unit vaccine that is likely to hit the Indian market in the next few months.

Biological E will conduct a bridging trial for the vaccine in India. The vaccine has shown encouraging results in Phase 1 and 2 clinical trials. 

According to the new rules announced by the Ministry of Health and Family Welfare recently, any firm that has received approval for their vaccine, in their country can get the Emergency Use Authorisation (EUA), without conducting a bridging trial first. But the trials can be conducted parallelly while the vaccine is being administered to the masses.

As per the deal, Providence will provide Biological E with the necessary technology transfer needed to manufacture the vaccines in India. It will have a minimum production capacity of 600 million doses in 2022, with a target capacity of one billion doses.

Meanwhile, Biological E is also working on its own subunit vaccine candidate. It has finished Phase I/II clinical trials and has got approvals to conduct Phase III clinical trials from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC).

India will have enough COVID-19 vaccine doses to inoculate up to one crore people per day by mid-July or early August, the government asserted on Tuesday as it underlined that there is no shortage of jabs and called for patience citing the country's large population.

Noting that the ferocious second wave is on the verge of abating, the government said that ramping up of testing as well as containment at the district level "has worked" in bringing down the cases. At the same time, it cautioned that while the easing of lockdown is imperative, it has to be done very slowly.

"Whatever we know from possible scenarios presented by eminent people, it (COVID) will decline and June will be much much better but the concerns are when we open up how do we behave because the virus has not gone anywhere,'' NITI Aayog member (Health) V K Paul said.

Addressing a press conference, ICMR Director-General Dr Balram Bhargava said India's vaccination is being ramped up, and "by December we hope to have the whole country vaccinated".

He mentioned that India is one of the five countries which are producing vaccines and asserted that "there is no shortage of vaccines". "By mid-of year, mid-July or early August, we will have more than enough doses to vaccinate up to a crore per day," he said.

Joint Secretary in Health Ministry Lav Agarwal said 4,03,49,830 vaccine doses were supplied from the Centre to states free of cost in May while 2,66,50,500 doses were directly procured by states and 1,24,54,760 doses were directly procured by private hospitals.

In the past month, a total of 7,94,55,090 doses were available, of which 6,10,57,003 doses have been administered. The cumulative number of COVID-19 vaccine doses administered in the country has reached 21,60,46,638, according to the ministry data.

Bhargava said in the first week of April there were less than 200 districts that had more than 10 percent case positivity which in the last week of April rose to nearly 600 districts.

India ramped up testing as well as containment which worked but still 239 districts have more than 10 percent positivity, 145 districts have a positivity between 5 to 10 percent while 350 districts, which is nearly half of India, have less than 5 percent case positivity, he said.

Agarwal said there has been a continuous decrease in daily cases since India reported a peak on May 7. There has been an almost 69 percent decline in COVID-19 cases since the highest peak, he said.

Also, there has been a consistent decline in active cases which presently stand at 18.95 lakh. A decrease in active cases by more than 18 lakhs since the peak on May 10 (a decline of almost 50 percent) has been observed.