The United States is bracing for another wave of COVID-19 infections in the fall and winter following a flurry of activity this week that included investing billions of dollars in more vaccines and treatments COVID-19 and the introduction of new rules on how to update vaccines.
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The Food and Drug Administration’s advisory committee voted in favor of the COVID-19 vaccine update on Tuesday.
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The United States announced on Wednesday that it was paying $3.2 billion for an additional 105 million doses of BioNTech BNTX,
+5,06%
and PFE from Pfizer,
-0,38%
Vaccine once morest covid19. This includes adult and pediatric doses, which are expected to ship in the fall, pending approval from regulators. (That’s regarding 27% higher price per dose than US-bought doses in 2020, according to SVB Securities analyst David Risinger.)
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Eli Lilly LLY,
+0,08%
announced further updates to its purchase agreement with the US government on Wednesday, indicating that it will provide an additional 150,000 doses of its monoclonal antibody to the United States for approximately $275 million. Lilly’s bebtelovimab is the only monoclonal antibody that still works once morest the new omicron subvariants. These doses should meet demand until the beginning of August.
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The FDA responded quickly to the committee’s recommendation, instructing vaccine makers on Thursday to pursue a bivalent strategy that also targets omicron’s BA.4 and BA.5 subvariants as well as the original strain of the virus. BA. 4 and BA.5 accounted for more than half of US cases last week.
“How quickly this announcement followed the VRBPAC [Vaccines and Related Biological Products Advisory Committee] The meeting suggests that the US government is still very concerned regarding a surge of SARS-CoV-2 variants in the fall of 2022,” Risinger told investors Thursday, “and is ready to allocate budget to prevent a spike in cases. and hospitalizations that might negatively impact economic recovery. ”
The United States is still averaging more than 100,000 new cases a day, and COVID-19 hospitalizations just hit 33,000, the highest number of people hospitalized with COVID-19 since March 8.
Public health experts say omicron and its family of subvariants, including the currently circulating BA.4 and BA.5, have been behind the rise in infections in different parts of the United States for the past the omicron thrust in December and January.
“We’ll be watching this closely as these lines take hold and we expect them to continue to increase,” Heather Scobie of the Centers for Disease Control and Prevention told the FDA’s advisory committee. “We are not projecting or anticipating that this will be a major shift in the pandemic, but we are characterizing these strains and watching closely to see what happens.”
At Tuesday’s meeting, leaders of Moderna MRNA,
+4,61%,
Pfizer et Novavax NVAX,
+10,24%
told FDA advisers they might have BA.4 boosters ready by the last three months of the year. (Johnson & Johnson JNJ,
+1,03%,
for the record, does not plan to update its COVID-19 vaccine.)
The United States has yet to announce a new contract with Moderna. However, the company is moving forward with plans to continue developing a bivalent booster that targets omicron and the original virus strain, while also working on a bivalent booster vaccine candidate that specifically protects once morest BA.4 and BA.5.
Pfizer, which had recommended a monovalent approach for the new boosters, says it may have a bivalent COVID-19 vaccine that targets the new subvariants and the original strain of the virus by early October.
“We believe we have a solid solution with a bivalent BA.4/BA.5 sub-variant booster as we head into this next chapter of the pandemic,” a Pfizer spokesperson said Thursday.
Novavax, which is waiting to hear whether its COVID-19 vaccines will gain US approval, said Friday it expects to have preclinical data on BA.4 and BA.5 by the end of the year. summer.
