Serum signs Covid vaccine deal with US-based Novavax; gets exclusive rights for India

American vaccine development company Novavax Inc on Wednesday announced that it has entered a supply and license agreement with the Serum Institute of India (SII) for the development and commercialization of its COVID-19 vaccine candidate.

According to media reports, the Pune based SII will have exclusive rights for the vaccine in India during the term of the deal and non-exclusive rights during the “Pandemic Period” in all countries other than those designated by the World Bank as upper-middle or high-income countries.

Novavax could start Phase III trial in September

The deal was signed on July 30, according to an SEC filing by Novavax. On Tuesday, Novavax reported that its experimental Coronavirus vaccine produced high levels of antibodies against the virus in a small, early-stage clinical trial and that it could start a large pivotal Phase III trial as soon as late September.

Novavax research chief Gregory Glenn told Reuters the late-stage clinical trial could potentially glean enough data to obtain regulatory approvals as early as December.

Maryland-based company's shares saw huge swings in extended trading as investors took a critical eye to early data on its experimental vaccine for COVID-19 following a 3,800% rally in the stock this year. The shares briefly fell as much as 34% postmarket on Tuesday, before paring the decline. In trading before regular hours Wednesday, they were up 21%.

DCGI gives nod to SII to conduct human trials

Meanwhile, last week, the Drugs Controller General of India (DCGI) gave nod to the Serum Institute of India for conducting phase 2 and 3 human clinical trials of the Oxford University's COVID-19 vaccine candidate in the country.

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Bharat Biotech and Zydus Cadila, which have been conducting early-stage testing of their candidates Covaxin and ZyCov-D over the last 20 days, are also starting second phase trials, Indian Council of Medical Research (ICMR) Director-General Dr Balram Bhargava said on Tuesday.

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With a single-day spike of 56,282 new COVID-19 cases and 904 deaths in the last 24 hours, India's COVID-19 tally reached 19,64,537 on Thursday. With the increase of 904 deaths, the toll due to the disease now stands at 40,699 in the country, according to the Union Ministry of Health and Family Welfare (MoHFW). The COVID-19 count includes 5,95,501 active cases and 13,28,337 cured/discharged/migrated patients.

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(With agency inputs)