Omicron Covid Variant, Omicron Coronavirus Variant, Omicron Variant News: “List of mutations we never wanted to see”: Omicron Vs Vaccine Makers

Omicron Covid variant: In 2020, it took Moderna 42 days to produce the original Covid vaccine.

At a factory nestled along a freeway 20 miles north of Boston, hundreds of Pfizer Inc. employees prepare to produce millions of doses of a new vaccine that increasingly looks like the next phase fight against Covid-19.

Work on the project began the day after Thanksgiving at the 70-acre facility in Andover, Massachusetts, just as the World Health Organization designated a new strain of coronavirus, omicron, a variant of concern. The goal of the effort: to provide a personalized booster against the highly mutated virus in less than 100 days.

No one knows just how far omicron will spread, how serious its infections will be, or even if further injections will be needed. Senior White House medical adviser Anthony Fauci said reports of the severity so far have been “encouraging.”

Of 43 omicron infections in the United States analyzed by the Centers for Disease Control and Prevention, four-fifths were in fully vaccinated people, although almost all cases were relatively mild. British health officials expect omicron to overtake the delta as the dominant strain within days.

The researchers are alarmed by around 30 mutations in the tip of omicron, the protein that facilitates the entry of the coronavirus into cells. The changes in its appearance make it more difficult for antibodies to find and destroy the variant. This prompted Pfizer, its partner BioNTech SE and their messenger RNA rival Moderna Inc. to launch efforts to target it directly.

“That was the list of mutations we never wanted to see,” said Moderna president Stephen Hoge, who heads the company’s scientific operations. The vaccine maker, whose mRNA plant is just 40 miles from Pfizer’s, began work on omicron on the Tuesday before Thanksgiving, and meetings ran throughout the holidays. Many employees “saw their Thanksgiving ruined” by omicron, Hoge said.

Initial laboratory data suggests that three doses of existing mRNA vaccines protect against omicron. What is less clear is how long this protection lasts, since the Covid antibodies have decreased over time. Pfizer hopes to have the first real-world efficacy data on how its existing vaccine behaves against the variant before the end of the year.

While companies are discreet about the details of their exact location, both are determined to react quickly. When news of the variant emerged from South Africa, Pfizer CEO Albert Bourla almost immediately decided to begin large-scale manufacturing of an omicron-specific shot. The work accelerated so quickly that Pfizer did not estimate its costs.

“I can’t give you the number at the moment; I’m not even sure we’ve talked about it,” said Mike McDermott, Pfizer’s global supply chain manager, who gives Bourla updates. regular on progress. It is very unusual for a pharmaceutical company to start large-scale manufacturing of a product that may not be needed, he said.

The production process at Andover could start any day now, McDermott said. Workers wait for company researchers in Chesterfield, Missouri to finalize and deliver a master cell line containing a genetic sequence that will be used in the targeted vaccine.

The Andover plant Pfizer, acquired in 2009 during the $ 68 billion purchase of vaccine maker Wyeth, specializes in biologics. For the Covid vaccine, it performs two first steps: producing large amounts of a DNA template for the vaccine from the cell line, and then converting it to the mRNA which forms the nucleus of the vaccine.

The mRNA will be sent to another Pfizer facility in Kalamazoo, Michigan. This facility makes the lipid nanoparticles that coat mRNA and protect it from the body’s enzymes that degrade it. Kalamazoo also has vaccine vial filling operations.

South of Boston, Moderna’s facility in Norwood, Massachusetts has clean rooms for manufacturing mRNA and lipid nanoparticles that coat fragile genetic material. Formerly owned by Polaroid, the plant is the vaccine maker’s first and has grown rapidly since the start of the pandemic.

In 2020, it took Moderna 42 days to produce batches of its original Covid vaccine and 63 days to begin human trials with government researchers. With omicron, “our goal is to hit a timeline like this for sure,” said Hoge, President of Moderna.

One of the reasons Pfizer and Moderna can scale quickly with omicron is that they perfected the process with the original vaccines as well as vaccine variants for the beta and delta strains that the companies produced earlier this year. Although the delta and beta variant vaccines may not be necessary, they have provided a blank trial for omicron.

Even after the vaccine vials are filled and finished, there are uncertainties, starting with what human trial regulators will demand, if any. Current FDA guidelines, which the agency reiterated in an email, call for immunogenicity testing to compare the human immune response to viral variants induced by the modified vaccine against the response to the licensed vaccine.

But Pfizer’s chief research officer Mikael Dolsten said the company was looking at whether, in an emergency, it could get clearance without the omicron-specific testing. The agency may allow drugmakers to submit human data from other variant-specific vaccines that show its approach is likely to be successful.

The FDA declined to comment on confidential discussions with vaccine developers. ” She said she encouraged them to contact early and often to discuss the clinical data needed for new vaccines to help fight Covid.

If further booster immune response trials were needed, they would likely involve a few hundred people and take a few months, Moderna’s Hoge said. “At the end of the day, the FDA has to tell us what it wants,” he said.

Another question is how quickly omicron is growing outside of South Africa. The strain emerged at a time when the country’s workload was quite low – there wasn’t much competition with other variants. In the best case scenario, the new strain could be overtaken by delta in most countries and gradually disappear.

Until then, however, drug manufacturers cannot capitalize on this possibility. Pfizer plans to have the new doses ready by February or early March, Dolsten said.

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