News Analysis India

Tag: efficacy

  • Novavax Begins Phase 3 Trials For Its Vaccine In US, Mexico

    Final phase trials to determine the efficacy of a COVID-19 vaccine developed by Maryland based firm Novavax Inc. has begun in US and Mexico, National Institute of Health (NIH) announced on December 28. The randomized, placebo-controlled trials will enrol approximately 30,000 people over the age of 18, with emphasis on people aged 65 and above. The tests to finally determine if NVX-CoV2373 jabs were fit for emergency use, would be conducted at approximately 115 sites across both the North American countries.

    According to NIH, all volunteers would be needed to give informed consent prior to their participation. For the trials, two-third of the participants would randomly receive the vaccine and one third would receive a saline placebo. Randomization will be in a 2:1 ratio with two volunteers receiving the investigational vaccine for each one who receives a placebo. Throughout the duration of trials, neither the investigators no the participants would know if they’ve received the vaccine or the placebo. All the volunteers would receive the second injection after the duration of 21 days.

  • Fauci Promotes COVID-19 Vaccine Safety And Efficacy Among African Americans

    In a bid to instil confidence among the African-American communities over the safety and efficacy of COVID-19 vaccine, US top infectious disease expert Dr Anthony Fauci said that one of the major vaccine candidates has been worked on by an African- American woman.

    In an interview with CNN, the director of the National Institute of Allergy and Infectious Diseases (NIAD) said that the vaccine which has shown “absolutely exquisite levels” of efficacy against the novel coronavirus was actually developed by his team’s Dr Barney Graham and Dr Kizzmekia Corbett. 

    He was reportedly referring to the COVID-19 vaccine that will be released by Moderna. Corbett, who is also the lead scientist for the National Institute’s of Health’s coronavirus vaccine research has reportedly said that people who have doubts regarding the safety of the vaccine have a right to ask questions. 

  • Bharat Biotech said – Covaxine expected to be available in first quarter of next year

    Covaxin, a vaccine for COVID-19, will be available in the first quarter of next year, said Suchitra Ella, joint managing director of Bharat Biotech on Wednesday.

    “With safety and efficacy data, Covaxin will be available in the first quarter of next year to the categories and the first responders according to the plan that govt of India is embarking upon for phased vaccination,” Ella told ANI.
    A team of foreign heads of missions in India had visited leading biotech companies in Hyderabad involved in COVID-19 vaccine development.

    The Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India (SII), and Hyderabad-based Bharat Biotech have applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation (EUA) for their COVID-19 vaccines.

    Meanwhile, Subject Expert Committee (SEC) of Drugs Controller General of India (DCGI) has asked for more safety and efficacy data from Serum Institute of India (SII) and Bharat Biotech for their COVID-19 vaccines.

    According to government sources, an SEC meeting was held on Wednesday to review the application submitted by the pharma majors for emergency use authorisation (EUA) for their vaccine candidates.The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

  • Japan Parliament Approves Bill To Provide Free COVID-19 Vaccine To Its 126 Mn Residents

    Japan’s parliament on Wednesday, December 2 approved the bill to provide free COVID-19 vaccination to its 126 million people. The bill received the approval of the upper house of the parliament after being passed in the powerful lower house. The bill will make the local authorities of Japan responsible for managing the immunisations across prefectures. 

    The passage of the bill comes at a time when Japan is suffering from a second wave of the disease. The bill includes a provision that would require citizens to make efforts towards getting vaccinated, but it won’t come into effect until the safety and efficacy of the vaccine are proven. The bill would also allow the government to compensate private companies in case health problems occur from vaccination resulting in financial losses.

    Japanese Prime Minister Yoshihide Suga has vowed to put all efforts into securing vaccines as soon as they are approved by the regulators. According to the Japan Times, the country has reportedly secured 120 million doses of potential COVID-19 vaccine from British firm AstraZeneca, while another 60 and 25 million doses from American giants Pfizer and Moderna respectively. However, not everyone in Japan is enthusiastic about getting vaccinated as a survey from Ipsos showed that only 69 percent of Japanese residents are willing to get a vaccine, which is lower than the global average of 73 percent. 

  • Sputnik V 92% effective against coronavirus, claims Russia

    Russia on Wednesday said that its vaccine Sputnik V is 92 per cent effective at protecting people from COVID-19 according to the first interim analysis.

    “The Sputnik V vaccine efficacy amounted to 92 per cent (calculation based on the 20 confirmed COVID-19 cases split between vaccinated individuals and those who received the placebo),” the Russian Direct Investment Fund (RDIF) said in a statement read. Currently, Sputnik V phase III clinical trials are approved and are undergoing in Belarus, the UAE, Venezuela and other countries. In India, phase II-III trails of the vaccine are underway.

    Currently, 40,000 volunteers are taking part in double-blind, randomised, placebo-controlled Phase III of Sputnik V clinical trials, out of which over 20,000 have been vaccinated with the first dose of the vaccine and more than 16,000 with both the first and second doses of the vaccine.

    Russian Health Minister Mikhail Murashko said: “The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, a preventive healthcare tool, and this is the most successful path to defeat the pandemic.”

    The efficacy was demonstrated on the basis of a first interim analysis obtained 21 days after the first injection. There were no unexpected adverse events during the trials and monitoring of the participants is ongoing.

    The announcement by Russia comes days after drug giant American Pfizer announced that its coronavirus vaccine was more than 90 per cent effective at protecting people from infection as compared to placebo saline shot, as per an analysis.

    Russia became the first country to register the world’s first COVID-19 vaccine on August 11. Sputnik V was developed by the Gamaleya National Research Centre for Epidemiology and Microbiology of the Russian Healthcare Ministry.

    The company said that the Gamaleya Centre team will publish the interim research data in one of the leading international peer-reviewed medical journals.