COVID-19 antivirals on the horizon as Omicron variant causes concern

Scientists in southern Africa identified the new Omicron variant earlier this month, and the World Health Organization declared it a “variant of concern” last week. Omicron has more than 30 mutations on its spike protein, sparking fears that it might evade immunity from vaccination or past infection. Two previous variants, Beta and Mu, had spike protein variants that helped them overcome immunity, but neither was especially contagious, and neither caused worldwide surges. The Delta variant, on the other hand, was not exceptionally better at evading immunity, but it was so contagious that it became the dominant strain of SARS-CoV-2, the virus that causes COVID-19, in a matter of months.

Variant activity in South Africa

Source: Tulio de Oliveira, Director of Center for Epidemic Response and Innovation, South Africa.

There is much we don’t yet know about this variant. For example, we don’t know:

• How contagious Omicron is. Preliminary reports suggest that it could be responsible for a large increase in cases in South Africa and thus might be more contagious than Delta, although the baseline rate of Delta infection was low when Omicron was initially detected.
• If it causes more severe disease. Based on a handful of cases, Omicron may have different symptoms than typically seen with COVID-19 to date.
• How much, if at all, Omicron will decrease the protection offered by vaccines or previous infection. Both Pfizer/BioNTech and Moderna have announced that they are developing vaccines to specifically target Omicron, although these will not be available until next year.

Omicron has already been reported in countries in Asia Pacific (Australia), the Middle East (Israel), Europe (Britain, Germany, Italy, Belgium, Denmark and the Netherlands) and North America (Canada), and we should expect to see more reported Omicron cases across the globe in the coming weeks, especially if it is indeed more contagious than other strains. Many countries have imposed travel restrictions and bans on southern Africa, but at most these will likely only delay spread by a few weeks and may discourage countries from reporting new variants in the future. Israel has closed its borders completely as of November 27, 2021.

Implications for employers:

• It’s highly likely that Omicron is already present in the U.S. Vaccinations continue to be one of the most important ways to protect employees and the community from waves of infection. Getting employees vaccinated now, before Omicron is widespread in the U.S., could prevent substantial illness and business disruption.
• Companies can start to make contingency plans for workplace safety through masks, distancing and remote work if Omicron is found to be more contagious, especially if it decreases vaccine effectiveness.
• Employers should be especially cautious about sending employees on cross-border work travel, as they run the risk of employees being held in quarantine.

Border disruptions will likely lead to further business disruptions, particularly during this busy economic and holiday period.

Pharmacists will be able to prescribe the new COVID-19 antivirals

Two COVID-19 antiviral treatments, molnupiravir (Merck) and paxlovid (Pfizer), are likely to be approved in the U.S. in the next few weeks. Molnupiravir is already approved in the U.K. under the name Lagevrio. Each reduces the risk of hospitalization between 30% to 89% in high risk people. The challenge is that these drugs need to be administered within either three or five days of first symptoms, and our medical system isn’t ideally situated to accomplish this. Many people will have a hard time getting a test, getting a doctor’s appointment and getting a prescription during the window when these drugs are most effective.

However, pharmacists will be allowed to prescribe anti-COVID-19 drugs directly, with no physician required. Pharmacists are already responsible for a large portion of COVID-19 vaccinations, and they have made influenza vaccines dramatically more accessible. Allowing medical professionals to practice at the “top of their licenses” helps increase access and can decrease cost. During the pandemic, the immunizations delivered by pharmacists have likely saved tens of thousands of lives.

Implications for employers:

• Increased access to oral medications that reduce the risk of complications from COVID-19 will help save lives and decrease economic disruption. Employers should be sure that these drugs are available on formulary for their members.

Molnupiravir effectiveness lower than initially thought

Merck provided the final analysis of the study showing the effectiveness of molnupiravir. The drug prevents 30% of hospitalizations (not the 50% initially stated). There were still substantially more deaths in the placebo group (nine) compared to the group randomly assigned to molnupiravir (one).

Implications for employers:

• The Food and Drug Administration will be weighing approval of molnupiravir on November 30, 2021, and Pfizer’s antiviral, paxlovid, in the coming weeks. Both are likely to be approved.
• While the federal government is paying for these drugs now, at some point their cost will be borne by employer-sponsored health insurance.
• Keeping people from needing to be hospitalized may lead to medical cost savings, depending on the price of these medications.
• These antivirals are likely to be effective, regardless of mutations of future new variants.

COVID-19 dramatically increases the risk of miscarriage

The Centers for Disease Control and Prevention reported that COVID-19 infection during pregnancy roughly doubled the risk of miscarriage and quadrupled the risk of miscarriage in the months since the Delta variant has been predominant here.

COVID-19 and risk of miscarriage

Implications for employers:

• There is no evidence that COVID-19 vaccinations decrease fertility, and they are strongly indicated for women who are considering getting pregnant.
• COVID-19 vaccines have proven safe in pregnancy and they induce immunity in both mother and baby.
• There is no clinical reason that pregnancy should be considered a reason for a medical exemption from a vaccine mandate. As always, companies should consult their legal counsel as they develop exemption criteria.

Current antibody tests can’t tell us if we’re immune, but future tests might

We can test for immunity to many viruses by a simple blood test. For instance, we can get an antibody test to see if we need a booster for measles, or if we are already immune to hepatitis B. However, the antibody tests currently available are not calibrated to assess whether an individual is indeed immune from SARS CoV2, the virus that causes COVID-19.

The journal Science recently reported a direct correlation between antibody levels and protection from COVID-19 – the first step to developing accurate tests that could tell us when we need a booster and whether someone who recovered from COVID-19 is well protected. This could also make it easier to test effectiveness of vaccines in the future.

Implications for employers:

• Antibody status should not be used to assess whether employees are immune from the coronavirus at this point.

Author

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Jeff Levin-Scherz, MD

Population Health Leader, Health and Benefits, North America

Jeff is an internal medicine physician and has led WTW’s clinical response to COVID-19 and other health-related topics. He has served in leadership roles in provider organizations and a health plan and is an Assistant Professor at Harvard Chan School of Public Health.

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