• The World Health Organisation (WHO) granted emergency use approval for Bharat Biotech’s COVID-19 vaccine Covaxin, adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19 caused by SARS-CoV-2.

• The announcement by the WHO came after the Technical Advisory Group (TAG), an independent advisory committee of the world body recommended emergency use listing (EUL) status for Covaxin.

• WHO’s decision is expected to help millions of Indians who have received Covaxin to travel outside the country.

• The WHO has so far granted emergency approval to the vaccines made by AstraZeneca and its partner the Serum Institute of India, Pfizer-BioNTech, Moderna Inc., Johnson & Johnson, and the Chinese pharmaceuticals Sinopharm and Sinovac.

• WHO’s emergency use listing (EUL) is a prerequisite for COVAX Facility vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.

• With the validation from the WHO countries can now expedite their regulatory approval processes to import and administer Covaxin.

Covaxin

• Covaxin (BBV152) has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).

• The vaccine was developed using Whole-Virion Inactivated Vero Cell derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.

• The vaccine has been formulated to enable shipping and long-term storage at 2-8 degrees Celsius. It is also formulated to adhere to a multi-dose vial policy, thereby reducing open vial wastage, saving money to procurement agencies and governments alike.

WHO’s evaluation of the vaccine

• Covaxin was assessed under the WHO EUL procedure based on the review of data on quality, safety, efficacy, a risk management plan and programmatic suitability. 

• The Technical Advisory Group (TAG), convened by WHO and made up of regulatory experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs risks and the vaccine can be used globally.

• Covaxin was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) on October 5, which formulates vaccine specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women).

• The SAGE recommended use of the vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. 

• Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low and middle-income countries due to easy storage requirements.

• Available data from clinical trials on vaccination of pregnant women are insufficient to assess vaccine safety or efficacy in pregnancy. However, initial studies were reassuring.

What is the procedure for getting WHO approval?

• The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. 

• The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.

• The EUL pathway involves a rigorous assessment of late phase 2 and phase 3 clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. 

• These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

• As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.

What is the role of SAGE?

• The Strategic Advisory Group of Experts (SAGE) on Immunization was established by the Director-General of the WHO in 1999 to provide guidance on the work of WHO. 

• SAGE is the principal advisory group to WHO for vaccines and immunization. 

• It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. 

• SAGE is concerned not just with childhood vaccines and immunization, but all vaccine-preventable diseases.

• SAGE assesses evidence on safety, efficacy, effectiveness, impact and programmatic suitability, considering both individual and public health impact.

• SAGE meets at least twice a year, with working groups established for detailed review of specific topics prior to discussion by the full group.

• UNICEF, the Secretariat of the GAVI Alliance, and WHO Regional Offices participate as observers in SAGE meetings and deliberations.

• SAGE Interim recommendations for EUL products provide guidance for national vaccination policy makers. These recommendations are updated as additional evidence becomes available and as there are changes to the epidemiology of disease and the availability of additional vaccines and other disease control interventions.

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