Covid-19: A Vision for the “New Normal” and Pfizer’s Paxlovid

Early in the pandemic, there was a lot of talk about the “new normal,” with most people wanting to get back to the “old normal.” Two-plus years into the pandemic, it’s obvious that COVID-19 isn’t going away, prompting discussion about what this “new normal” will actually look like. For that and more COVID-19 news, continue reading.

New Normal: COVID-19 More Like Cigarette Smoking 

Dr. Benjamin Mazer, writing for The Atlantic, proposes a new way of thinking about COVID-19 becoming endemic. Instead of the common, “it will become like the flu,” Dr. Mazer, an anatomic and clinical pathologist with the Yale School of Medicine, suggests the “new normal” will arrive when we acknowledge that COVID’s risks have become more in line with those of smoking cigarettes—and that many COVID deaths, like many smoking-related deaths, could be prevented with a single intervention.”

That intervention, of course, is vaccination. As he points out, “The pandemic’s greatest source of danger has transformed from a pathogen into a behavior. Choosing not to get vaccinated against COVID is, right now, a modifiable health risk on par with smoking, which kills more than 400,000 people each year in the United States.”

An unvaccinated adult is 68 times more likely to die from COVID-19 than an adult who has received two shots and a booster. Currently, vaccine hesitancy in the U.S. is responsible for more than 163,000 preventable deaths, and there’s no indication that number will be the final figure. A comparison, he notes, is that smokers are 15 to 30 times more likely than non-smokers to develop lung cancer. An open question is whether insurance companies will respond to non-vaccinated people the way they often respond to smokers — by increasing their rates.

Full Peer-Reviewed Data Published on Pfizer’s Antiviral Paxlovid 

Although granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration about two months ago, Pfizer has only now published peer-reviewed data on its COVID-19 antiviral combo, Paxlovid (nirmatrelvir and ritonavir). The data from the Phase II/III EPIC-HR study was published in The New England Journal of Medicine. It evaluated about 2,246 unvaccinated, non-hospitalized patients at high risk of severe COVID-19.

Source: BioSpace

The study found those taking Paxlovid were 88.9% less likely to die or be hospitalized compared to those in the placebo group. The 88.9% figure was almost identical to an interim analysis of 774 patients, which was 89.1%. There was more safety data in the final analysis, with 22.6% of patients receiving the drug having adverse events, compared to 23.9% in the placebo cohort. Serious events showed up in 1.6% of the Paxlovid group, compared to 6.6% of the placebo group. COVID-19-related symptoms appeared to be the cause of the higher adverse events in the control group.

Pfizer is taking some criticism over its patent protection policy for the therapy. Although it has agreed to make the drug available in 95 low and middle-income countries, it is simultaneously filing patents in numerous other countries. The company projected sales of $22 billion this year for Paxlovid, which could be lower if additional contracts are inked or extended with countries not currently in on the Medicines Patent Pool (MPP). MPP is a United Nations-backed public health organization. Pfizer and MPP entered their voluntary license deal in November 2021, which allows MPP to facilitate more production and distribution of the therapy.

Omicron Subvariant BA.2 Appears to Cause More Severe Disease 

As the Omicron wave subsides in the U.S., researchers and public health officials are keeping an eye on a subvariant—actually an apparent sister strain of the original Omicron variant—dubbed BA.2. BA.2 appears to be more transmissible than BA.1, the original Omicron, and new research is also suggesting it may cause more severe disease. Like Omicron, BA.2 also appears to be able to mostly escape vaccine-driven immunity, although boosters restore some of that protection. BA.2 also seems resistant to GlaxoSmithKline’s monoclonal antibody sotrovimab (Xevudy), which is being used to treat Omicron BA.1. The study, which came from researchers in Japan, has not been peer-reviewed yet.

COVID-19 Vaccination Protects Against Long COVID

An analysis of 15 studies suggests that COVID-19 vaccination protects against developing Long Covid. The study was conducted by the UK Health Security Agency (UKHSA). The UKHSA estimates 2% of people in the UK with COVID-19 developed Long Covid, with symptoms lasting longer than four weeks after the original infection. But eight of the 15 studies show strong evidence that people who received two shots of a COVID-19 vaccine are half as likely to go on to develop Long Covid. Four more studies suggested people who receive a vaccine after being diagnosed with Long Covid see symptoms improve.

Will a Fourth Shot be Necessary? Too Soon to Tell.

Although antibody titers drop several months after receiving the original
COVID-19 shots, a third booster shot brings those levels back up, which was recommended to help protect against the Omicron variant. But as the antibody levels drop after the booster, many people are wondering if a fourth dose will be necessary. It did not consider long-term protection related to improved quality of antibodies and memory T and B cells.

“That’s what a lot of people are asking me,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID). “The answer is if you look at where we are now, it looks like it’s good protection; 78% is good.”

Research from the U.S. Centers for Disease Control and Prevention that analyzed hospitalizations and Emergency Department visits in 10 states found that protection by the Moderna or Pfizer-BioNTech vaccines against hospitalization dropped from 91% two months after the third shot to 78% after four to five months.

The real question will be not only if protection drops, but how steeply. It’s also dependent on whether any new, more transmissible variants emerge. At this point, public health officials believe the boosters in normally healthy people are sufficient, although a fourth dose might be useful for high-risk individuals or those who are immunosuppressed.

BioSpace source: