This past week saw some action on COVID-19 vaccine front, possibly offering more tools to fight the pandemic in next few months.
Dr Reddy’s said it is planning to apply for emergency-use approval (EUA) of Russia's Sputnik V COVID-19 vaccine by March, expects possible approval by the end of that month. The company has contract with Russian sovereign fund RDIF for 125 million patient doses (250 million doses) for India. RDIF has earlier announced that its vaccine would be priced below $10.
The data from clinical trials of Johnson & Johnson and Novavax, which were announced this week, were also positive increasing the chances of the vaccine availability. Interestingly, both these vaccines will be manufactured in India.
India has already rolled out Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. The government plans to vaccinate 3 crore healthcare and frontline workers in the initial phase of the COVID-19 vaccination. India would need 2.6 billion doses to vaccinate its entire population.
J&J and Novavax positive data
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Johnson & Johnson’s has announced that its single shot vaccine has shown to have 72 percent efficacy rate in the US, 66 percent effective overall at preventing moderate to severe COVID-19, 28 days after vaccination. The vaccine has been 85 percent effective overall in preventing severe disease and demonstrated complete protection against COVID-19 related hospitalization and death as of day 28. However the vaccine efficacy has dropped to 57 percent in South Africa, where a highly contagious variant, known as known as B.1.351 has emerged as the leading cause of infection rate.
The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The trial was conducted in US, Latin American countries and South Africa.
J&J single-dose vaccine can prove to be a gamechanger, especially in a country with a large population, such as India, where two doses will consume tremendous resources. Most importantly J&J vaccine is expected to be available in India much sooner, as Indian vaccine maker Biological E has entered into an agreement with J&J to manufacture the drug substance and finished product of the vaccine. J&J had earlier said that the partnership with Biological E, allows for production of 400-500 million doses per year.
The government, in its recent presentation, said the J&J vaccine is expected to be around $10 per dose.
Please read here why J&J’s COVID-19 vaccine is generating lot of interest.
Data from Novavax COVID-19 vaccine too has raised hopes. The vaccine developed by US-biotechnology company met the primary endpoint, with 89.3 percent efficacy in its Phase 3 clinical trial conducted in the UK. However in South African clinical trial, the vaccine efficacy dropped to 60 percent in the 94 percent of the study population that was HIV-negative. The UK variant B.1.1.7 and South African variant B.1.351 have now emerged has dominant strains.The vaccine would be manufactured and distributed by its partner SII, with which Novavax has an agreement to produce around 2 billion doses a year. SII said it plans to begin a bridge trial in India in February 2021. The vaccine has to be given in two doses. The government, in its recent presentation, said the Novavax vaccine is expected to cost around $16 per dose.