Pfizer Antiviral Brings Game Against Omicron, Genetics for Loss of Smell/Taste ID’d

Although researchers are warning us not to let our guard down, there’s intense focus on how well (or poorly) vaccines and antivirals work against the Omicron variant of SARS-CoV-2. For those stories and more, continue reading.

Pfizer’s Antiviral Paxlovid Appears Effective Against Omicron

Pfizer released data from several studies showing that nirmatrelvir, the active main protease inhibitor of its antiviral combination therapy Paxlovid (nirmatrelvir/ritonavir) is effective against the Omicron variant of SARS-CoV-2. The in vitro studies suggest Paxlovid can maintain plasma concentrations “many-fold times higher” to prevent Omicron from replicating than is required.

“We specifically designed Paxlovid to retain its activity across coronaviruses, as well as current variants of concern with predominantly spike protein mutations,” said Dr. Mikael Dolsten, chief scientific officer and president, worldwide research, development and medical at Pfizer. “Following the clinical findings — showing Paxlovid reduced risk of hospitalization or death by nearly 90% compared to placebo for high-risk patients when treated within five days of symptom onset — we are encouraged by these initial laboratory findings. These data suggest that our oral COVID-19 therapy can be an important and effective tool in our continued battle against this devastating virus and current variants of concern, including the highly transmissible Omicron.”

BioNTech Study: 3 Doses of Vaccine Neutralizes Omicron

A study published in the journal Science demonstrated that three doses of the Pfizer-BioNTech COVID-19 vaccine increased antibody levels against the Omicron variant. It tested sera from 51 participants, which was then challenged with the wildtype Wuhan, Beta, Delta or Omicron pseudoviruses. Participants had either two or three doses of the Pfizer-BioNTech vaccine. The authors noted that neutralizing antibodies are only a single measure of vaccine effectiveness and don’t show effectiveness per se, but they can be strongly predictive of immune protection against symptomatic COVID-19 infection. The overall conclusion was that three doses of Pfizer-BioNTech neutralized Omicron at a similar order of magnitude as two shots did against the wild-type Wuhan strain.

Genetic Risk Factors for Loss of Smell and Taste with COVID-19 ID’ed

A study conducted by 23andMe and published in Nature Genetics identified a genetic risk factor tied to the loss of smell from COVID-19. Data suggests that as many as 1.6 million people in the U.S. alone experienced a change in their ability to smell from COVID-19 or an inability to smell. The theory is that it is caused by damage to infected cells in the olfactory epithelium in the nose. Researchers identified a genetic locus near two olfactory genes that are tied to the loss of taste and smell. This risk factor appears to increase the probability of a COVID-19 patient experiencing a loss of smell or taste by 11%. Other studies suggest 4 out of 5 COVID-19 patients will regain taste and smell. In 69,841 people who self-reported a positive COVID-19 test, 68% also reported a loss of taste or smell. In analyzing the data, the researchers found a part of the genome near two genes, UGT2A1 and UGT2A2, both of which are expressed in tissue inside the nose that is involved in smell.

“It was this really beautiful example of science where, starting with a large body of activated research participants who have done this 23andMe test, we were able to very quickly gain some biological insights into this disease that would otherwise be very, very difficult to do,” said Adam Auton, vice president of human genetics at 23andMe and lead author of the study.

COVID-19 Much More Dangerous to the Heart than Vaccination

Although study after study has already shown that the risk of COVID-19 is far higher than any risk from the vaccines, yet another underscores the point. Cardiovascular comorbidities are some of the greatest risk factors for hospitalization with COVID-19, and a significant percentage of hospitalized patients with COVID-19 have evidence of heart damage and may recover from the disease but have lasting cardiovascular damage. One of the rare side effects of some of the COVID-19 vaccines is myocarditis, an inflammation of the heart muscle. Prior to COVID-19, the incidence of myocarditis was between one and 10 cases per 100,000 people per day. The highest rates are in males between 18 and 30, and typically the highest risk is in otherwise healthy and active individuals. The risk of myocarditis after COVID-19 infection is 146 cases per 100,000, with highest risk for males over the age of 50 and children under 16 years. The risk of myocarditis associated with COVID-19 vaccines is 2.13 cases per 100,000 vaccinated, which is within the range of the unvaccinated population. Other studies have put the overall incidence of vaccine-associated myocarditis between 0.3 and 5 cases per 100,000.

Revive Updates Progress of Bucillamine for COVID-19

Revive Therapeutics provided an update on its Phase III trial of Bucillamine to treat mild to moderate COVID-19. So far, 701 subjects have been dosed. With Delta Health, Revive initiated expanded enrollment in Turkey. The company is on schedule to complete enrollment in the first quarter of 2022 and is prepping its regulatory package to the U.S. Food and Drug Administration and other global regulators. Bucillamine has been approved for the treatment of rheumatoid arthritis in Japan and South Korea for more than 30 years. It is a cysteine derivative with two thiol groups and has strong anti-inflammatory activity.

WHO Warns Omicron May Not Be the End

The World Health Organization (WHO) warned that the Omicron variant may not be the end of the COVID-19 pandemic. The organization notes that high levels of COVID-19 around the world may give rise to other variants.

“We’re hearing a lot of people suggest that Omicron is the last variant, that it’s over after this,” said Maria Van Kerkhove, the WHO’s COVID-19 technical lead. “And that is not the case because this virus is circulating at a very intense level around the world.”

New infections have grown by 20% worldwide over the past week, with almost 19 million total reported cases. And that figure may be low because new infections often go unreported.

Another WHO official, Dr. Bruce Aylward, weighed in as well, saying, “We don’t fully understand the consequences of letting this thing run. Most of what we’ve seen so far in areas of uncontrolled transmission has been we paid a price for the variants that emerge and new uncertainties we have to manage as we go forward.”