COVID Update: Pill Production Underway and Vaccines in Pregnant Women

Antiviral pills against COVID-19 show promise for making the disease more treatable and convenient, but they are not broadly accessible yet. However, Merck and Ridgeback announced they have manufactured the first 10 million courses of their pills, which is a good start. For that and more COVID-19 news, continue reading.

Merck and Ridgeback Make First 10 Million Courses of Molnupiravir

Merck & Co. and Ridgeback Biotherapeutics announced they have supplied about 3.1 million courses of their antiviral drug against COVID-19, molnupiravir, to the U.S. government. They reported they have manufactured about 10 million courses so far and are on schedule to produce at least 20 million courses more this year. Merck had inked a procurement deal with the U.S. government in late 2021, where it agreed to supply about 3.1 million courses of the drug to the U.S. government once it received Emergency Use Authorization.

“As we start 2022, more than 2,000 COVID-19 deaths are being reported in the U.S. daily, which underscores the need for medicines including molnupiravir that can be taken at home,” said Robert M. Davis, chief executive officer and president, Merck. “In line with our commitment to accelerating access to molnupiravir in the U.S., we have now supplied more than 3 million courses to the U.S. government within approximately seven weeks of receiving Emergency Use Authorization from the U.S. Food and Drug Administration.”

Pharmacies Concerned About Low Payment for Antiviral Drugs

The two newest antiviral drugs against COVID-19 are Merck and Ridgeback’s molnupiravir and Pfizer’s Paxlovid. The other is Gilead’s Veklury (remdesivir), which is an infusion, compared to the other two that are pills.

Some pharmacies are expressing dismay at how little they receive to dispense these pills, with reimbursement as low as $1. Pharmacies receive an “ingredient cost” and a “dispensing fee” for drugs. But because the federal government is paying for the pills, pharmacies only receive dispensing fees. In November 2021, federal officials ordered pharmacy benefit managers (PBMs) to pay dispensing fees for the pills that are “sufficient to ensure eligible patients can readily access these drugs at available pharmacies.” They also said the fees might be higher than a sponsor’s typical negotiated dispensing fees because of the unique circumstances of the pandemic.

The dispensing fees vary, but Prime Therapeutics’ is $1, Humana’s is $2, Express Scripts‘ is $6, CVS Caremark‘s is $10 and OptumRx’ is $10.50. The federal government’s dispensing fee for uninsured patients is $12, and some Medicaid programs pay about $10. There have been reports of pharmacists who stopped offering antiviral pills because of low reimbursement.

COVID-19 Vaccination Significantly Benefits Pregnant Women

A study funded by the National Institutes of Health found that vaccination against COVID-19 not only protects pregnant women against the disease but their babies as well. That study also found that pregnant women with moderate COVID-19 symptoms have a higher risk for complications during pregnancy than people who are not infected or who have mild or no symptoms. These risks include a higher chance of a Cesarean section, preterm delivery, death around the time of birth, postpartum hemorrhage, and a higher risk of miscarriage. The study included almost 13,000 pregnant women, with about 2,400 infected with COVID-19.

A separate study out of Massachusetts General Hospital demonstrated that COVID-19 vaccinations during pregnancy created higher antibody levels in the mothers as well as more persistent antibodies in their babies—greater than that created from natural infection in the mothers.

“Pregnant women are at extremely high risk for serious complications from COVID,” said Dr. Galit Alter, co-senior author of the MGH study. “And given the lag in development of COVID-19 vaccines for infants, these data should motivate mothers to get vaccinated and even boosted during pregnancy to empower their babies’ defenses against COVID.”

Full Recovery from Long COVID is Hard to Find

A number of studies launched by the NIH are soon to be read out, but early indications are that, although some people are recovering from Long COVID, full recovery is still not that common.

“The good news is, even after six months, we’ve really had the wonderful opportunity to watch people get better,” said Dr. W. Michael Brode, medical director of the post-COVID program at University of Texas Health at Austin, Texas. “Although I certainly have seen my share of people who got sick in March and April of 2020, and they’re better, but not close to 100%.”

There are now 44 Long COVID clinics in 48 states. Long COVID’s official name is Post-Acute Sequelae of SARS-CoV-2 infection (PASC) and includes a range of symptoms that continue for weeks, months and potentially years after initial diagnosis. There are at least 50 possible symptoms, including neurologic and psychiatric, cardiovascular and pulmonary, gastrointestinal and musculoskeletal. A Centers for Disease Control and Prevention study published in JAMA Network Open estimates about 1 in 10 people will develop Long COVID symptoms more than a month after infection. The more severe the disease, the higher the likelihood of PASC.

More COVID ID’ed in Deer

COVID-19 has been identified in a number of animals, including deer, housecats, tigers, lions, minks, and of course, primates. Although it was observed in white-tail deer before, Penn State researchers recently confirmed the first Omicron variant case infecting a wild animal, a deer in Staten Island, N.Y. The biggest concern about the virus infecting animals is that the animals will become a reservoir for the virus, which will then re-infect humans. Deer, in particular, travel widely, seem to be asymptomatic, and have a fair amount of interaction with humans versus, for example, mountain lions. Hunters have been warned to take precautions when handling deer carcasses, suggesting they wear rubber gloves or face masks.