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Bharat Biotech – Emergency Vaccine Approval

“It’s not vaccines that will end the pandemic but the availability of them that will”

Bharat Biotech, a biotechnological company known for its R&D and manufacturing capabilities, is expecting the approval of its COVID-19 vaccine, Covaxin from the World Health Organization for Emergency Use Listing (EUL) by Q3 or Q4. EUL is a process by which new or unlicensed products can be used using public health emergencies.

Before we get into the details, it’s important to know the background of Covaxin, the first coronavirus Indian vaccine to be approved for trials in July 2020. The company began its Phase 1 and 2 in July-October 2020 and announced the Phase 3 trial in mid-November, 2020.

Phase 1 and 2 trials which began with 755 participants, proved the company’s claim to produce antibodies to coronavirus. However, apart from the authorization of vaccines from Oxford University and AstraZeneca, the Indian government granted emergency authorization to Covaxin in January, 2021 without the release of phase 3 results which had 25,800 participants. The vaccine, fortunately, has had a 78% efficacy rate against the virus.

Source – Reuters

The company, Bharat Biotech, has been rushing to get the process of EUL started. Since, without the official recognition by the WHO, the people who have been vaccinated by Covaxin are not being allowed to travel overseas in some of the countries that require arrivals to be vaccinated. 

Regulatory approvals for Covaxin are in process in more than 60 countries including Brazil and Hungary. The USA, Canada, Australia, Ireland and European Union are among those that have not approved the Indian coronavirus vaccine. Emergency use authorization of the said vaccine has been obtained by 13 countries to date.

90% of the documents required for the vaccine’s EUL have been submitted to the WHO. The rest of which, said the company, will be filed by June. The WHO has declared the prequalification of the emergency use procedure as confidential. It will, however, release the results of any vaccine that does manage to meet the criteria.

Bharat Biotech which submitted the documents on April 19 showing interest in EUI, was asked by the WHO on May 18, to proffer further information. Some countries have introduced vaccine passports which will be given only to those who have received the WHO approved vaccines.

Vaccine passports act as proof that the holder has been vaccinated against a given disease and is hence safe to enter the country. However, the WHO last month said that it was against the introduction of the vaccination’s proof as a requirement for international travel.

The approval of the Covaxin by WHO will encourage many countries to import the vaccine and will especially be beneficial to the developing countries which do not possess sufficient technology. The US company is currently waiting for additional information from the Phase 3 trials, for a EUA submission.

Source – bharatbiotech.com

While the vaccine is definitely a means to end the pandemic, we as individuals also need to act rationally and follow the precautions that have been issued by the government. It is critical to wear your masks everywhere you go. As far as possible, individuals are encouraged to stay at home and take care of their physical as well as mental health.

 

Written By – Devarshi Adwani

Edited By – Roshni Divecha

                                                           

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