COVID-19 Weekly Newsletter: FDA Considers COVID-19 Pill, Travel Restrictions To Be Lifted

Faegre Drinker Biddle & Reath LLP

A new submission for a Food and Drug Administration (FDA) emergency use authorization (EUA), new guidance for travelers entering the U.S. and continued studies into the efficacy of booster shots headlined this week’s COVID-19-related news.

FDA Panel Supports Booster Shot

The one-dose, viral vector vaccine currently authorized in the United States for a single dose received an important endorsement from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) today. In a 19-0 vote, the advisory committee unanimously agreed on the safety and effectiveness of the vaccine for use as a booster dose in individuals 18 years and older at least two months after the original single dose primary vaccine. This recommendation will now go to the FDA who has the ultimate authority to amend the company’s emergency use authorization to allow the second dose.

Drug Manufacturer Submits EUA for COVID-19 Antiviral Pill

This week, a biopharmaceutical and a biotechnology company submitted its FDA EUA for Molnupiravir, a five-day course oral medication for mild to moderate COVID-19. If approved by the) for an EUA, it would be the first COVID-19 oral medication available, as current therapies authorized require an IV or injection. The FDA's Antimicrobial Drugs Advisory Committee (AMDAC) will meet on November 30 to review the companies’ data and potentially cast their vote on their recommendation.

19-Month Travel Ban on Nonessential Travel Scheduled to End in Early November

Starting in early November, international travelers from specified countries will be able to fly directly into the United States, regardless of reason for travel, if they are fully vaccinated by a recognized COVID-19 vaccine; provide suitable evidence of that vaccination prior to boarding their flight; and also provide evidence of a suitable negative COVID test result taken within three days prior to boarding their flight. The Centers for Disease Control and Prevention (CDC) confirmed on October 11, 2021, that recognized vaccines will be those that are approved or authorized by either the FDA or the World Health Organization (WHO). In addition to air travel restrictions being lifted, the Canadian and Mexican land and ferry crossings will be opened to vaccinated foreign travelers to the U.S. in early November as well.

Two mRNA Vaccines Found To Be Most Effective Boosters

Per preliminary findings from a NIH-funded study, COVID-19 booster shots from the two-dose mRNA based COVID-19 vaccines indicated they are more effective at protecting vaccinated adults than a second dose of the one-dose vaccine approved for use in the U.S. The results could create a challenge for the government, which has not yet recommended mixing vaccines. During today’s VRBPAC meeting, experts are expected to consider the results of the mix-and-match study, though it’s not scheduled to make any recommendations on the approach.

New WHO Advisory Group

On Wednesday, WHO announced a new 26-member Scientific Advisory Group for the Origins of Novel Pathogens that will be tasked with advising WHO on what is needed to track the origins of the virus. The WHO is seeking comment until Oct. 27 on the selected members, which were chosen from among more than 700 applications.

Impact on COVID-19 Spread in U.S.

The epidemiological and economic impact of COVID-19 in the U.S. was studied under different social distancing mitigation strategies such as voluntary home isolation, school closures and stay-home/lockdown orders. The researchers of this modeling study concluded that stay-at-home orders and high compliance with voluntary isolation resulted in large economic losses — but was also found to have saved over 110,000 lives and prevent 115 million infections compared to no mitigation measures.

Second COVID-19 Test May Be Indicator for Severe Disease

Predicting the severity of a COVID-19 infection after diagnosis has proved challenging. One study has reported that a conducting a second PCR test 2-7 days after a positive COVID-19 test could help identify patients at greater risk of severe illness.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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