WHO Provides Interim Policy Guidelines and Lists Extra COVID-19 Vaccines for Emergency Use
As per the World Health Organization (WHO) listings, the Sinopharm COVID-19 vaccine paves the way for its global rollout. Beijing Bio-Institute of Biological Products Co Ltd, are the ones who manufacture the Sinopharm vaccine (CNBG). “The inclusion of this vaccine has the potential to accelerate COVID-19 vaccine access for countries seeking to guard vulnerable populations and health workers and,” said Dr. Mariangela Simo, WHO Assistant Director-General for Access to Health Products.
The Emergency Use Listing (EUL) of the World Health Organization (WHO) is needed for the COVAX Facility vaccine supply. The EUL evaluates COVID-19 vaccine consistency, and safety, as well as risk management plans and programmatic suitability, such as cold chain specifications. It also enables countries to expedite their regulatory approval for the manufacture and administration of COVID-19 vaccines. The review is carried out by the product evaluation committee, which is made up of regulatory experts from all over the world, and a Technical Advisory Group (TAG), which is in charge of conducting the risk-benefit analysis for an independent decision.
The vaccine is also reviewed by SAGE, WHO's Strategic Advisory Group of Experts on Immunization. Based on all available data, WHO recommends the vaccine for adults 18 and older, in two doses spaced three to four weeks apart. In both age groups combined, vaccine efficacy for the symptomatic and hospitalized disease was calculated to be 79%. Since few older adults (over 60 years old), effectiveness could not be calculated. Nonetheless, the WHO does not prescribe a maximum age for the vaccine because preliminary evidence and supportive immunogenicity data indicate that the vaccine is likely to have a protective impact on older people.
WHO's list of emergency uses
The emergency use listing (EUL) aim is to make medications, vaccines, and diagnostics available as soon as possible to resolve the emergency while adhering to strict protection, effectiveness, and consistency requirements. The EUL pathway entails a thorough review of late phase II and phases III clinical trial results, as well as significant additional data on safety, effectiveness, efficiency, and a risk management strategy.
On 31 December 2020, the WHO reported the Pfizer/BioNTech vaccine for emergency use. On 15 February 2021, two AstraZeneca/Oxford COVID-19 vaccines were provided by AstraZeneca-SKBio (Republic of Korea) and therefore the Serum Institute of India. On 12 March 2021, COVID-19 vaccine Ad26.COV2.S was developed by Janssen (Johnson & Johnson).
Pfizer/BioNTech, Astrazeneca-SK Bio, Serum Institute of India, Janssen, and Moderna vaccines have also been identified for emergency use by the WHO.
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