Influenza A H1N1 vaccine(Bharat Biotech International Ltd.)

As a massive COVID-19 surge continues to rage on throughout India, scientists and public health officials scramble to determine whether currently authorized vaccines in the country can provide a mitigation effect to this unprecedented spread. A new study published online has provided some hope, with researchers suggesting that the Covaxin vaccine, developed by Bharat Biotech and Pennsylvania-based Ocugen, could neutralize the SARS-CoV-2 variant leading the second wave in India. On Saturday, a total of 346,786 new COVID-19 cases were recorded by India's Ministry of Health and Welfare, exceeding the country's record of the most significant number of new, daily infections reported by any other country. Over the past few days, India has reported a mean of 331,000 new COVID-19 infections per day, a stark contrast to the fewer than 15,000 cases reported in early March of this year. A relatively new, more transmissible strain of the virus that contains 2 mutations – E484Q and L452R – appears to be leading the recent surge in India. The prevalence of this variant, called B.1.617, has increased to up to 52% in sequenced blood samples this month. So far, up to 20 countries, including Australia, Germany, Ireland, Belgium, New Zealand, Singapore, Namibia, the U.K. and the U.S., have reported cases of B.1.617. In India, there have been three authorized vaccines for COVID-19, including Russia's Sputnik V, Bharat Biotech's Covaxin, and the Indian-manufactured vaccine of AstraZeneca Covishield. The Indian government also discusses whether to authorize COVID-19 vaccines Pfizer, Moderna, and Johnson & Johnson. A recent study published in the preprint server bioRxiv suggests Covaxin neutralizes the B.1.617, providing hope for the country currently taking the hardest hit from the novel coronavirus. In this study, the investigators examined the level of antibodies necessary to neutralize the infectious variance in serum samples from 17 individuals who have recovered from COVID-19. These are recovered patients were previously infected with variants B.1.1.7 (n=2), B.1.351(n=2), B.1.1.28.2(n=2) and B1 (n=11). Findings were compared with data obtained from sera samples of patients who received Covaxin. The researchers found a similar neutralization capacity against B.1.617 in vaccinated people and those who had recovered from COVID-19. Results from this small study have not yet been peer reviewed. On Monday morning, shares of Ocugen surged in pre-market trading after the White House said it will back India in fighting the country's COVID-19 case spike. Stock in OCGN was up 16.3% by 7:30 am ET. And on Sunday, the White House said the U.S. had found sources of specific raw material needed to manufacture the Covishield vaccine, developed by AstraZeneca with Oxford University, in India. This material will be made immediately available in the country. On the U.S. front, Ocugen has struck a deal with Bharat to manage Covaxin's commercialization in the states pending approval from U.S. regulators. Last week, an interim analysis of Phase III trial data showed the vaccine had a 78% efficacy against mild-to-moderate COVID-19 as well as a 100% efficacy against severe infection. The efficacy of the vaccine against mild-to-moderate disease decreased from the initial 81% demonstrated in the first interim analysis. The findings are still promising and may continue to support bringing the vaccine to the U.S. market. "We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date," said Shankar Musunuri, Chairman and Chief Executive Officer of Ocugen, in a statement. "We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market."

According to the U.S. Centers for Disease Control and Prevention (CDC)’s COVID Data Tracker, 107,028,890 total COVID-19 vaccine doses have been delivered and 80,540,474 administered. Of those, 26,957,804 have received two doses. Distribution and administration of the Johnson & Johnson vaccine began this week, which will change the metric a bit, because it only requires a single shot. There is also additional COVID-19 news. Here’s a look. CureVac and Novartis Partner on Manufacturing CureVac’s COVID-19 Vaccine Germany’s CureVac NV inked a deal with Switzerland’s Novartis AG to manufacture CureVac’s COVID-19 vaccine candidate, CVnCoV. They have already begun work on it, including technology transfer and test runs. After the final agreement, Novartis plans to manufacture the mRNA and bulk drug product for the vaccine for up to 50 million doses by the end of this year and up to another 200 million doses in 2022. They expect delivery from their manufacturing location in Kundl, Austria to begin in the summer of this year. CureVac’s integrated European vaccine manufacturing network includes Bayer, Fareva, Wacker and Rentschler. “I am very pleased that with Novartis we have found another highly experienced partner to support the production of our vaccine candidate,” said Florian von der Mulbe, chief production officer of CureVac. “Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base.” Novavax Expects FDA Emergency Use Authorization for its COVID-19 Vaccine by May Earlier this week, Novavax’s chief executive officer, Stanley Erck, said he expected the U.S. Food and Drug Administration (FDA) might grant the company’s COVID-19 vaccine emergency use authorization (EUA) by May. The company reported positive interim data from the Phase III trial in the UK in January, where the vaccine candidate demonstrated 89.3% efficacy. It included the most common wildtype Wuhan strain, as well as the UK and South African variants. Novavax also signed a deal with Poland’s Mabion SA to possibly produce the COVID-19 vaccine. Mabion will initiate commercial-scale production trials of Novavax’s vaccine and the technology transfer will begin. The company would be part of Novavax’s plan to supply 1.5 billion doses of the vaccine already contracted globally. Novavax also believes the vaccine will be approved for use in Europe this quarter. European Regulators Begin Rolling Review of Russia’s Sputnik V COVID-19 Vaccine The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) initiated a rolling review of Sputnik V (Gam-COVID-vac), Russia’s Gamaleya National Centre of Epidemiology and Microbiology’s COVID-19 vaccine. The rolling review launch was based on data from lab studies and clinical trials in adults. The data suggests that the vaccine triggers antibodies and immune cells that target SARS-COV-2 and may help protect against COVID-19. EMA will determine if the benefits outweigh the risk and if the vaccine complies with the usual EU standards for effectiveness, safety and quality. They didn’t provide a timeline other than to say it should “take less time than normal to evaluate an eventual application because of the work done during the rolling review.” Bharat Biotech’s COVID-19 Demonstrated 81% Efficacy Bharat Biotech, based in India, reported interim vaccine efficacy of 81% for its COVID-19 vaccine. The interim data analysis was based on 43 recorded cases of the disease in the trial of 25,800 people. The Phase III trial was conducted in partnership with the Indian government’s medical research division. Of the 43 cases, 36 received a placebo, compared with seven who received the Bharat Biotech vaccine. The country approved the vaccine, COVAXIN, in January ahead of Phase III efficacy data. India has begun vaccinating its population using COVAXIN and the Oxford-AstraZeneca vaccine. MediciNova Discontinues Development of its COVID-19 Vaccine MediciNova, based in La Jolla, California, announced that after a careful review of its development programs, it was discontinuing development of its COVID-19 vaccine. The decision, they indicated was “to maintain adequate resources for its other development programs which have indications with larger unmet medical needs and market opportunities.” The last time the company announced anything related to its COVID-19 vaccine was on November 24, 2020. At that time, MedicieNova announced that Good Manufacturing Practice (GMP)-based Master Virus Seed Stock (MVSS) production of the vaccine, using BC-PIV technology, was initiated at Millipore Sigma BioReliance Service, a group company of Merck KGaA, Darmstadt, Germany. Most Read Today