A vision for the “new normal” and Pfizer’s Paxlovid – PharmaLive
A vision for the “new normal” and Pfizer’s Paxlovid – PharmaLive

A vision for the “new normal” and Pfizer’s Paxlovid – PharmaLive

Early in the pandemic, there was a lot of talk about the “new normal,” with most people wanting to return to the “old normal.” Two years or more into the pandemic, it is clear that COVID-19 is not disappearing, giving rise to discussion about what this “new normal” will actually look like. For that and more COVID-19 news, keep reading.

New normal: COVID-19 more like cigarette smoking

Dr. Benjamin Mazer, writes for Atlantic Ocean, suggests a new way of thinking about how COVID-19 becomes endemic. Instead of the usual, “it will be like the flu,” suggests Dr. Mazer, an anatomical and clinical pathologist at the Yale School of Medicine, says the “new normal” will come when we recognize that COVID’s risks have become more consistent with those of smoking cigarettes – and that many COVID deaths, like many smoking-related deaths could be prevented with a single intervention. “

That intervention is, of course, vaccination. As he points out, “The pandemic’s greatest source of danger has turned from a pathogen into a behavior. Choosing not to be vaccinated against COVID is right now a modifiable health risk along the lines of smoking that 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, the hesitation with vaccines in the United States is responsible for more than 163,000 preventable deaths, and there is no indication that the number will be the final number. One comparison, he notes, is that smokers are 15 to 30 times more likely to develop lung cancer than non-smokers. An open question is whether insurance companies will respond to unvaccinated people as 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 United States Food and Drug Administration about two months ago, Pfizer have only now published peer-reviewed data on their COVID-19 antiviral combination, Paxlovid (nirmatrelvir and ritonavir). The data from the Phase II / III EPIC-HR study were published in New England Journal of Medicine. It evaluated approximately 2,246 unvaccinated, non-hospitalized patients at high risk for severe COVID-19.

Source: BioSpace

The study showed that those taking Paxlovid were 88.9% less likely to die or be hospitalized compared to those in the placebo group. The figure of 88.9% was almost identical to an interim analysis of 774 patients, which was 89.1%. There were several safety data in the final analysis, with 22.6% of the patients receiving the drug having side effects compared to 23.9% in the placebo cohort. Serious events occurred 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 reactions in the control group.

Pfizer is takes some criticism over its patent protection policy for the therapy. Although it has helped make the drug available in 95 low- and middle-income countries, it also files patents in several other countries. The company expected sales of $ 22 billion this year for Paxlovid, which could be lower if additional contracts are signed or extended with countries not currently part of the Medicines Patent Pool (MPP). MPP is a UN-funded public health organization. Pfizer and MPP ind their voluntary licensing agreement in November 2021, which allows the MPP to facilitate more production and distribution of the treatment.

Omicron Subvariant BA.2 appears to cause more serious illness

As the Omicron wave declines in the United States, researchers and public health authorities are keeping an eye on a subvariant – in fact, an apparent sister strain of the original Omicron variant – called BA.2. BA.2 appears to be more transferable than BA.1, the original Omicron, and new research also suggests that it may cause more serious illness. Like Omicron, BA.2 also appears to be able to escape vaccine-driven immunity for the most part, although boosters restore some of this protection. BA.2 is also resistant to GlaxoSmithKline’s monoclonal antibody sotrovimab (Xevudy), which is 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 prolonged 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 that 2% of people in the UK with COVID-19 developed Long Covid, with symptoms lasting longer than four weeks after the initial infection. However, eight of the 15 studies show strong evidence that individuals who received two shots of a COVID-19 vaccine are half as likely to develop Long Covid. A further four studies suggested that people who receive a vaccine after being diagnosed with Long Covid see symptoms improve.

Will a fourth shot be needed? Too early to tell.

Although antibody titers decrease several months after receipt of the original
COVID-19 shots, a third booster shot brings these levels back up, which was recommended to help protect against the Omicron variant. But as antibody levels drop after the booster, many people do wondering if a fourth dose will be needed. 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 ask 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 seems to be a good protection; 78% is good. “

Research from the USA Center for Disease Control and Prevention analyzing hospital admissions and visits to the emergency department in 10 states found that the protection of the Moderna or Pfizer-BioNTech vaccines against hospitalization fell from 91% two months after the third shot to 78% after four to five months.

The real question will not only be whether the protection falls, but how steep. It also depends on whether new, more transferable variants emerge. At this point, public health officials believe the boosters in normally healthy people are adequate, although a fourth dose may be helpful for high-risk individuals or those who are immunosuppressed.

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