There’s quite a bit of movement on the Omicron-specific booster shot and updated supply deals, despite world leaders shifting their attention away from the COVID-19 pandemic.
Whether it’s because of widely available vaccines and treatments or just general pandemic fatigue, the world and its leaders appear to have mostly shifted their attention away from the COVID-19 pandemic. Still, there’s quite a bit of movement on an Omicron-specific booster shot and updated supply deals. Here’s a look.
Pfizer Submits Paxlovid for Full Approval for Severe COVID-19
Pfizer submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Paxlovid (nirmatrelvir and ritonavir) for patients at high risk for severe COVID-19. The antiviral drug regimen is authorized for emergency use for mild-to-moderate COVID-19 in adults and children 12 years and older who have a positive COVID-19 test and who are at high risk for severe COVID-19, including hospitalization or death.
“Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce Paxlovid as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination state,” said Albert Bourla, Pfizer’s chairman and chief executive officer. “We look forward to working with the FDA toward full regulatory approval for Paxlovid.”
FDA Panel Recommended Omicron-Specific Vaccine, But Questions Remain
On Wednesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-2 to recommend an Omicron-specific COVID-19 booster. However, they left a few unanswered questions, including if the Omicron-specific vaccine should focus on the original BA.1 Omicron strain or one of the quickly spreading subvariants, such as BA.4 and BA.5 that are dominating.
For the most part, the committee and other experts think a bivalent booster that focuses on BA.4 or BA.5 is the way to go. It’s not clear if there’s consensus on whether children will be authorized for an Omicron-specific booster, given how little data there is on it. Pfizer and BioNTech believe an updated version of their vaccine could be ready in October, if the FDA clarifies its position. Moderna expects its candidate to be ready in late October or early November.
Although many will undoubtedly be eager for an Omicron-specific booster in the fall, the reality is that there are still millions of people in the U.S. who never acquired any booster shot. This is particularly true in the younger populations of eligible recipients, and fewer than 10% of kids between the ages of 5 to 11 have been boosted. In the 12 to 17 age group, only 28.7% have been boosted, and in the 18 to 49-year-old population, less than 40% have been boosted.
“Despite strong evidence for the value of a booster in providing more complete protection, we are seeing massive confusion on the need for third and fourth shots,” John Brownstein, Ph.D., an epidemiologist at Boston Children’s Hospital, told ABC News. “The slow uptake has created public health vulnerability as we face a surge from the BA.4 and BA.5 variants and likely a new variant this coming fall.”
In related news, Pfizer and BioNTech signed a new vaccine supply deal with the U.S. government. They will supply 105 million doses and may include the Omicron-adapted COVID-19 vaccines, should they be authorized. They expect the doses to be delivered as soon as late summer and continue into the fourth quarter of 2022.
Also, Eli Lilly modified its supply deal with the U.S. government for its antibody treatment, bebtelovimab. The therapy has been shown to be effective against the Omicron variant.
Study: COVID-19 Infections in Young Adults Last About 5 Days
Research out of Boston University found that for about 83% of healthy, vaccinated young adults who caught COVID-19 from either Delta or Omicron variants, their infections lasted about five days. The study was relatively small and included 92 people who tested positive for the disease after having received their initial series. All of the people except 17% converted by day six and were no longer considered infectious. This reinforces the idea of people in this age group isolating for five days.
Myocarditis with Vaccines: Still Rare, but Higher with Moderna Shots
A study published in JAMA Network Open that analyzed data from Ontario, Canada, found that heart inflammation, both myocarditis and pericarditis, was very rare from COVID-19 vaccines. However, it was higher for the Moderna vaccine than the Pfizer-BioNTech vaccine.
The rates were five times higher with a short dosing interval between shots. The study evaluated data on 19,740,741 doses of mRNA COVID-19 vaccines given in Ontario from December 14, 2020, to September 4, 2021. There were only 297 cases of myocarditis or pericarditis, or about 15 cases per million. Of them, 76.8% were males with a median age of 24 years. Most, or 69.7%, came after the second shot.
In a related story, researchers at the University of Maryland and other “big 10" schools are planning to follow athletes who had COVID-19 to better understand the disease’s effects on the heart. The registry leverages several tests, including MRIs, not typically conducted on positive COVID-19 patients.
G7 Summit: COVID-19 Wasn’t on the Agenda
When the Group of Seven (G7) summit was held a year ago, COVID-19 and the pandemic were the top priority. The group, which is made up of the leaders of the wealthiest democracies, met in Germany this week, and the pandemic wasn’t a major topic. Maybe it’s a good sign.
As NBC News noted, there were no announcements about new approaches to fighting the virus or expanding access to vaccines or treatments, and no masks were worn in public. Still, there were vaccine testing requirements for people traveling to the summit. The primary focus was on pressuring Russia over its war with Ukraine, food shortages and global infrastructure efforts to counter Chinese influence in developing countries.
Todos Reports Positive Phase II Data for Tollovir in COVID-19
Todos Medical announced biomarker data from its majority-owned joint venture 3CL Pharma’s Phase II trial of Tollovir in hospitalized COVID-19 patients. The data represented a positive correlation between data announced in January and biomarkers associated with acute phase immune response (IL-6), inflammation (C reactive protein), blood clotting (D-dimer) and immune response to COVID-19 (cPass neutralizing antibodies). Tollovir is an oral 3CL protease inhibitor and anti-cytokine therapeutic candidate for the treatment of Nidovirus viruses that includes coronaviruses such as SARS-CoV-2, SARS-CoV-1, MERS and 229E.
