US Food and Drug Administration

US Food and Drug Administration

Subject – IR

Context – WHO seal: Covaxin may be missing the USFDA ballast

Concept –

• Despite almost 12 crore people in India having been administered Bharat Biotech’s Covaxin, the absence of an approval from the US drug regulator could have come in the way of the vaccine’s speedy processing by the World Health Organization (WHO), for an emergency use tag.
• An approval from the US Food and Drug Administration would have worked in Covaxin’s favour in getting a speedy EUL from the WHO.
• The WHO relies on approvals from SRAs (Stringent Regulatory Authorities) and National Regulatory Authorities.
• Covaxin is, however, on the US Centres for Disease Control (CDC)’s list of Covid-19 vaccines.
• Though an EUL is not required for countries to source vaccines from a company, a WHO ratification facilitates easier travel.

About USFDA –

• The United States Food and Drug Administration (FDA or USFDA) is a federal agency of the Department of Health and Human Services.
• FDA is a government agency established in 1906 with the passage of the Federal Food and Drugs Act.
• The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feedand veterinary products.
• The FDA gives approval to regulated products before they can be sold in the U.S.
• FDA has the power to recall products on the market, if necessary, for safety and other reasons.
• The FDA is known for its work in regulating the development of new drugs. The FDA has developed rules regarding the clinical trials that must be done on all new medications. Pharmaceutical companies must test drugs through four phases of clinical trials before they can be marketed to individuals.
• The FDA approves products in the biotech and pharmaceutical industries, and its approval or rejection of a product can have a financial impact.
• The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services.
• The FDA has its headquarters in unincorporated White Oak, Maryland.

To know about Emergency Use Listing by WHO, please refer September 2021 DPN.

EUL process

• It is a complex one that takes about 12-24 months generally after submission of a dossier by a vaccine maker.
• However, in pandemic times, the review process has been faster to meet global requirements.
• The application and data submitted is reviewed by two groups – the Strategic Advisory Group of Experts on Immunisation (SAGE) and Technical Advisory Group (TAG) – an independent advisory group that provides recommendations to the WHO on whether a Covid vaccine can be listed for emergency use under the EUL procedure.
• As of now, the WHO has six vaccines on the approved list. They are from Pfizer-BioNTech, Moderna Janssen (Johnson & Johnson), Oxford/AstraZeneca and that includes Serum Institute of India’s Covishield (AstraZeneca’s formulation), Sinopharm and Sinovac.
• EUL is not must for exports. There is no link between EUL and exports. A vaccine maker can export its vaccines, subject to approval of the importing country’s health regulator
• However, EUL can augment demand for a particular vaccine as it facilitates easier international travel for people. And an EUL is important if the company wants to supply to the WHO-supported Covax facility that distributes to low- and middle-income countries

Technical Advisory Group (TAG)

• The core function of this Technical Advisory Group (TAG) of experts for educational institutions and COVID-19 would be to provide strategic and technical advice to WHO, UNESCO and UNICEF on matters relating to educational institutions and COVID-19 transmission.
• Recommendations from TAG, an independent advisory group, completes the WHO’s two-part EUL process.