Due to the U.S. Food and Drug Administration (FDA) and Centres for Disease Prevention and Control (CDC) not having approved the Indian-made Covaxin, under CDC rules, India’s Prime Minister Narendra Modi would have to quarantine for seven days upon his arrival on Wednesday evening in the U.S.
However, Modi is set to meet U.S. President Joe Biden in person on September 24. Modi is embarking on a three-day U.S visit this week to meet world leaders at the first Quadrilateral Security Dialogue (Quad) summit in Washington, D.C. The Quad nations comprise India, Japan, the United States and Australia. The U.S. visit is Modi’s first foreign trip in six months.
Covaxin is India’s first domestically made vaccine, and was found to be 93.4 percent effective against severe COVID-19 in phase three trials by Bharat Biotech, which makes the vaccine in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology.
However, the candidate has not been approved by the WHO, CDC or FDA. The only vaccine that the FDA has fully approved is the Pfizer-BioNTech vaccine, while the Moderna and Janssen (made by Johnson & Johnson) vaccines have been authorized for emergency use. The CDC has approved and authorized the same three vaccines for use.
CDC policy is that after international travel, passengers need to quarantine for seven days unless they have had a vaccine that has been authorized either by CDC, the FDA or the WHO. That would, therefore, apply to Modi.
Several other vaccines are being used outside the U.S., including the Russian-made Sputnik vaccine and the Chinese-made Sinovac, which have not been authorized in the States. Studies have found these vaccines to be effective at preventing severe COVID-19.
Newsweek has contacted Modi’s team for comment.
The Indian PM had the vaccine in March, when India opened up its vaccination program for the wider population.
Modi will meet Biden on September 24 in Washington, D.C, where they will discuss security issues and recent developments in Afghanistan. Modi will also hold several bi-lateral meetings with other Quad leaders and address the U.N. General Assembly in New York.
During his visit to the U.S., the Indian leader is expected to make a renewed push to the U.S, Japan and Australia to waive the vaccine patent globally.
India, along with South Africa, have supported the sharing of intellectual property rights for COVID-19 vaccine manufacturers. The two countries approached the World Trade Organization last October, calling on it to waive parts of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). The two countries argue that waiving the patent would ensure that poorer countries would have easy and fast access to COVID-19 vaccines.
However, several rich economies—including the U.S., EU and the U.K.—have blocked any such move. They argue it would stifle innovation at pharmaceutical companies by robbing them of the incentive to heavily invest in research and development of such vaccines, which would be especially counter productive in a pandemic.