Roundup: Moderna/Pfizer Confirm Booster Protection from Omicron; FDA Approves Antiviral Pills to Fight COVID; and More

Latest on Effectiveness of Moderna/Pfizer Boosters Against Omicron Variant

Moderna has released preliminary data finding that a third dose of its vaccine, a 50-microgram booster, produced a 37-fold increase in neutralizing antibodies against the Omicron variant.

Pfizer-BioNTech said earlier this month that a third shot of their vaccine restored robust protection to the level produced after the initial two-dose regimen against the original COVID-19. Studies have shown a third dose of the Pfizer-BioNTech vaccine increases neutralizing antibodies against Omicron by 25-fold, Pfizer said.

Meanwhile, the U.S. Centers for Disease Control and Prevention (CDC) confirmed this week that Omicron has rapidly surpassed Delta as the dominant variant nationwide, representing at least 73 percent of new COVID-19 cases. The CDC continues to emphasize how vital boosters have become since the emergence of Omicron, which is considered much more transmissible than the Delta variant.

“With other variants, like Delta, vaccines have remained effective at preventing severe illness, hospitalizations, and death,” states the CDC. “The recent emergence of Omicron further emphasizes the importance of vaccination and boosters.”

“The dramatic increase in COVID-19 cases from the Omicron variant is concerning to all,” said Stéphane Bancel, chief executive officer of Moderna, in a news release. “However, these data showing that the currently authorized Moderna COVID-19 booster can boost neutralizing antibody levels 37-fold higher than pre-boost levels are reassuring.”

FDA Approves Use of Pfizer’s Paxlovid, Merck’s Molnupiravir – First Antiviral Pills to Fight COVID-19

The U.S. Food and Drug Administration (FDA) has approved an emergency use authorization for the first antiviral pill to fight COVID-19 — Pfizer’s Paxlovid tablets — for the treatment of mild-to-moderate symptoms in adults and pediatric patients (12 years of age and older weighing at least 88 pounds).

Paxlovid is for patients have to have tested positive for COVID-19 and are “at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA said. Paxlovid is not authorized as a preventive measure before testing positive, the FDA said.

“Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended,” said the FDA.

On Thursday, the FDA authorized the use of Merck’s Molnupiravir pill for treating COVID-19, the second such emergency use authorization in two days. Molnupiravir is also for mild-to-moderate COVID-19 in adults with positive results who are at high risk for progression to severe COVID-19, including hospitalization or death. Molnupiravir is not authorized for use in patients younger than 18 years of age because it may affect bone and cartilage growth. 

Like Pfizer’s Paxlovid, Molnupiravir is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, referring to Wednesday’s approval of Paxlovid. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Study: Omicron Linked to a Five-Fold Higher Risk of Re-Infection

The fast-emerging Omicron variant can easily overcome a person’s immunity from a past COVID-19 infection, or antibodies from two vaccine doses, according to a new report from the Imperial College London.

U.K. researchers estimate that the risk of reinfection with the Omicron variant is 5.4 times greater than that of the Delta variant. That means that protection against reinfection by Omicron from past infection may be as low as 19 percent.

“Controlling for vaccine status, age, sex, ethnicity, asymptomatic status, region and specimen date … Omicron was associated with a 5.4-fold higher risk of reinfection compared with Delta,” the study concludes. “This suggests relatively low remaining levels of immunity from prior infection.”

However, vaccine effectiveness against symptomatic Omicron infection jumped to 55 percent to 80 percent after a third dose, or booster.

The study focuses on data from the U.K. Health Security Agency and the U.K.’s health service for all confirmed COVID-19 cases in England between Nov. 29 and Dec. 11. The study is yet to be peer-reviewed.

Researchers said that the severity of Omicron infections is difficult to determine at this early state of the new variant, which is more transmissible than the Delta variant.

“We find no evidence (for both risk of hospitalization attendance and symptom status) of omicron having different severity from delta,” the study said. Although it added that data on hospitalizations remains very limited.

Pfizer: Two Doses Not Adequate for Kids Ages 2-4, Will Add Third Dose in Trials

Two doses of a pediatric Pfizer-BioNTech COVID-19 vaccine failed to produce sufficient immune response in children aged 2 to under 5 in ongoing pediatric trials, the companies announced.

Pfizer-BioNTech will add a third dose as part of the trials to see if that spurs a more robust response. Children under 5 will get the third dose two months after they’ve received their second.

Currently, Pfizer-BioNTech vaccines are authorized for children and teens 5-17 years old.

The vaccine makers explained in a statement that the first two 3 microgram (mcg) doses spurred a good immune response in babies and children between 6 months and 2 years of age — but the two doses failed to do so in 2- to 5-year-olds.

“If the three-dose study is successful, Pfizer and BioNTech expect to submit data to regulators to support an Emergency Use Authorization (EUA) for children 6 months to under 5 years of age in the first half of 2022,” states a news release by the vaccine makers.

Pfizer stated it will also test third doses in older children who do not yet have authorization for boosters. Children ages 5 to 11, and 12 to 15, will get full-dose third shots in the trials. Only 16- and 17-year-olds are now eligible for a Pfizer-BioNTech booster.

Pfizer has reduced dosage sizes for children. For those 12 and older, the dose is 30 micrograms of vaccine. Dosage went down to 10 micrograms for kids 5 to 11, and down to 3 micrograms a dose for the youngest children.

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