April 30, 2021

COVID-19 Weekly Newsletter: Guidance and Developments as Global Vaccination Continues

This week, the CDC announced updated guidance regarding outdoor gatherings, and the Department of Labor is advancing new workplace safety standards. Meanwhile, dwindling U.S. vaccination rates and global vaccine access are fueling concern among scientists and world leaders.

CDC Updates Guidance, Eases Recommendations for Those Vaccinated

This week, the Centers for Disease Control and Prevention (CDC) updated their March guidance to say fully vaccinated Americans can safely meet outdoors with other fully vaccinated individuals without wearing a mask. However, a mask is still required to be worn when attending large gatherings and events. Fully vaccinated is defined as two weeks after the second dose of the mRNA vaccines are given or two weeks after the single-dose vaccine is administered.

Global Access to Vaccines Raises Intellectual Property Questions

While the United States has opened vaccine availability to all adults over age 16, vaccine access remains a struggle in many parts of the world. To address access gaps and growing cases in those areas, this week the Biden administration announced plans to send 60 million AstraZeneca doses to other countries, including India.

Meanwhile, policy discussions have continued about the responsibility of higher-income countries and vaccine developers to provide doses to low- and middle-income nations. Last year, South Africa and India filed a communication with the World Trade Organization seeking an international waiver of the Trade-Related Aspects of Intellectual Property Rights or TRIPS. If approved, the so-called TRIPS waiver would suspend global intellectual property protections around products that protect, contain and treat COVID-19 until the pandemic is under control. The suspension would apply to patents, copyrights, industrial designs, and undisclosed information. As of this week, the White House has not made a decision to support or oppose the proposed waiver, but the United States Trade Representative has recently commented on the issue and has had meetings with interested parties, including vaccine developers. Meanwhile, members of Congress have weighed in with the administration both in support and opposition of the waiver.

Biden Hits 100 Days, Delivers First Address to Congress

Friday, April 30 marks President Biden’s 100th day in office, a notable milestone in the president’s previously stated and achieved vaccine goals. During his first joint address to Congress Wednesday night, President Biden noted that the United States has administered 220 million doses of COVID-19 vaccines during his first 100 days, far surpassing his more conservative original goal of 100 million shots in 100 days. The president further touted the significant progress made against the pandemic in recent months, including an 80% decrease in senior citizen COVID-19-related deaths since January. While the address, given before a sparse crowd (due to COVID restrictions) in the House of Representatives chamber, touched on the goals of the first 100 days, the bulk of the speech was spent selling President Biden’s newly proposed American Jobs and American Families plans.

Biden Administration Advancing Workplace Safety Standards

Since the inauguration, many advocates and policymakers have urged the new administration to prioritize workplace safety standards. This week, the Department of Labor sent the Office of Management and Budget’s Office of Information and Regulatory Affairs rules drafted by the Occupational Safety and Health Administration (OSHA), requiring employers to supply masks to employees and to develop workplace exposure prevention plans. The Office is anticipated to take two weeks to review and publish the new requirements.

Low Uptick of Vaccination Among U.S. Troops

With a significant portion of the military declining vaccination along with deployed troops limited ability to socially distance effectively in close quarters, President Biden has started to consider requiring mandatory vaccinations for U.S. troops. The three vaccines being given to the civilian population are currently being administered under an emergency use authorization (EUA) by the Food and Drug Administration (FDA). Per current law, military personnel who are administered vaccines that are under an EUA must be provided informed consent. Mandatory inoculation can happen if the informed consent requirement is waived under the premise of national security or when the vaccines are fully approved by FDA, which would remove the need for informed consent.

U.S. Cruises Could Resume by Mid-July

Cruising has resumed in some parts of the world, carrying over 400,000 passengers and crew before the availability of vaccines. Relying only on mitigation and tracing protocols, the cruise industry has encountered fewer than 70 COVID-19 cases. In the U.S., passenger ships have not carried travelers from a U.S. port for over a year due to the pandemic. The cruise industry and communities whose economies rely heavily on cruises are eager to resume operations and are awaiting the green light from the CDC.

On April 1, 2021 the CDC released its “Framework for Conditional Sailing” to sharp criticism, with detractors calling it unworkable and not aligned with requirements for air travel and other related industries. This week, the CDC loosened their position; in a letter sent from the CDC to the cruise industry, the CDC outlined criteria and pathways to allow passenger ships to sail from U.S. ports by mid-July. The letter touched upon several topics, including:

  • Vaccinations: Ships can bypass simulated test voyages and move directly to commercial sailings if 98% of the crew and 95% of the passengers are fully vaccinated.
  • Simulated voyages: Applications submitted to CDC for simulated voyages will be reviewed within five days.
  • Testing: Fully vaccinated individuals will only need a simple viral test/rapid antigen test prior to boarding
  • Quarantining: Local passengers exposed to or contracting COVID-19 can quarantine at home if within driving distance, while others may quarantine in a hotel.

Some cruise lines have already publicly stated vaccination, testing and proven mitigation requirements ahead of the CDC’s letter, but there are still questions to be answered between now and mid-July, including how the guidance impacts those unable to be vaccinated and whether Florida Governor Ron DeSantis’ Executive Order (EO 21-81) prohibiting use of COVID-19 passports is a roadblock or unenforceable to ships sailing from Florida ports.

Vaccinations Are Slowing in U.S. and Second Doses Are Being Skipped

When the vaccines were first made available in the U.S. through emergency use authorization, eligibility criteria for vaccinations were prioritized by factors including risk, age and occupation. Combined with a fluctuating supply of vaccines, securing a vaccination appointment was initially very difficult. Now, there is no lack of eligible individuals (more than 50% of American adults have had at least one dose), but there is a slowdown in the rate of shots administered. Some of this is attributed to scheduling conflicts, but also to vaccine hesitancy as people are skipping their second dose (8%) or skipping the vaccine completely.

Surveys of individuals without underlying conditions cite reasons for not taking the vaccine including safety concerns, worries about side effects, lack of full FDA approval, recent pauses of vaccines over safety concerns, misinformation/conspiracy theories or ideological concerns. Worldwide education and promotion efforts are underway to encourage full vaccination. Without a greater percentage of the population vaccinated, new variants of COVID-19 will continue, and herd immunity will never be achieved. This is especially worrisome with the reported trend of younger people — the last cohort to become eligible for vaccinations — experiencing more severe COVID-19 symptoms requiring hospitalizations.

COVID-19 Adversely Affects Pregnancy and Newborns’ Health

A study of over 2,000 pregnant women from 18 countries found that COVID-19 during pregnancy is associated with more frequent adverse outcomes compared to uninfected cases. Those diagnosed with COVID-19 had higher rates of preterm birth, preeclampsia (high blood pressure with damage to kidneys and/or liver) and maternal mortality.

A separate study of the newborns whose mothers had tested positive for SARS-CoV-2 during pregnancy showed increased rates of respiratory disorder and other health complications in these infants. This study also observed a higher rate of preterm birth (defined as less than 37 weeks) in the SARS-CoV-2 positive group, compared to uninfected mothers.

COVID-19 Co-Infections and Secondary Infections

Coming down with one type of a germ does not prevent a person from catching another infection caused by a different pathogen. In fact, many human infections are dangerous because of the concurrent or follow-on co-infections that complicate the medical picture, hinder appropriate treatment and worsen the overall outcomes — such as a bout of viral influenza turning into a case of bacterial pneumonia. SARS-CoV-2 is no exception, and now data are becoming available about co-infections and secondary infections in COVID-19 patients. For example, a recent study documented such co-infections and secondary infections with Mycoplasma pneumoniae, Haemophilus influenzae, Streptococcus pneumonia, Respiratory Syncytia Virus and other viral, bacterial and fungal pathogens. Co-infections (detected within 48 hours upon admission to the hospital) were seen mostly in patients with mild or moderate COVID-19, while secondary infections were more frequent in severely ill and critical patients. The study serves as a reminder to clinicians to be vigilant about possible additional infections in their patients.

Clinical Guidance for Treating Rare Vaccine-Induced Blood Clots

The rare, but potentially fatal, blood clots seen after administration of COVID-19 vaccines are under active investigation by researchers. While scientists work to understand the causes and develop ways to predict, prevent or mitigate this side effect, professional societies have created — and are continuously updating — guidelines to help practicing clinicians take care of their patients, such as:

More COVID-19 Insights

COVID-19 Response — 2020 Hindsight and 2021 Vision Podcast

Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates
Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19
Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Tracking Fraud Related to the COVID-19 Pandemic
Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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