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Pfizer confirms experimental COVID pill appears effective against omicron variant

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Pfizer said Tuesday that its experimental COVID-19 pill appears effective against the omicron variant.

The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89 percent among high-risk adults when taken shortly after initial COVID-19 symptoms.

Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself.

For more coronavirus news, visit our dedicated page.

The updates come as COVID-19 cases, deaths and hospitalization are all rising again and the US hovers around 800,000 pandemic deaths. The latest surge, driven by the delta variant, is accelerating due to colder weather and more indoor gatherings, even as health officials brace for the impact of the emerging omicron mutant.

The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pickup at a pharmacy and take at home.

Pfizer’s data could help reassure regulators of its drug’s benefit after Merck disclosed smaller-than-expected benefits for its drug in final testing. Late last month, Merck said that its pill reduced hospitalizations and deaths by 30 percent in high-risk adults.

Both companies initially studied their drugs in unvaccinated adults who face the gravest risks from COVID-19, due to older age or health problems, such as asthma or obesity.

Pfizer is also studying its pill in lower-risk adults — including a subset who are vaccinated — but reported mixed data for that group on Tuesday.

In interim results, Pfizer said its drug failed to meet its main study goal: sustained relief from COVID-19 for four days during or after treatment, as reported by patients. But the drug did achieve a second goal by reducing hospitalizations by about 70 percent among that group, which included otherwise healthy unvaccinated adults and vaccinated adults with one or more health issues. Less than 1 percent of patients who got the drug were hospitalized, compared with 2.4 percent of patients who got a dummy pill.

An independent board of medical experts reviewed the data and recommended Pfizer continue the study to get the full results before proceeding further with regulators.

Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo.

The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases.

Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations.

The US government has agreed to purchase enough of Pfizer’s drug to treat 10 million people and enough of Merck’s to treat 3 million, pending FDA authorization.

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Pfizer-BioNTech begin omicron COVID-19 vaccine trial: Statement

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Pfizer and BioNTech have begun enrollment for a clinical trial to test the safety and immune response of their omicron-specific COVID-19 vaccine in adults aged up to 55, the companies said in a statement Tuesday.
For more coronavirus news, visit our dedicated page.
Pfizer’s CEO Albert Bourla previously said at a conference that the pharmaceutical giant could be ready to file for regulatory approval of the shot by March.
The company’s head of vaccine research Kathrin Jansen said in a statement that while current data showed that boosters against the original COVID-19 strain continued to protect against severe outcomes with omicron, the company was acting out of caution.
“We recognize the need to be prepared in the event this protection wanes over time and to potentially help address omicron and new variants in the future,” she said.
Ugur Sahin, CEO of the German biotech company BioNTech added that the protection of the original vaccine against mild and moderate COVID-19 appeared to wane more rapidly against omicron.
“This study is part of our science-based approach to develop a variant-based vaccine that achieves a similar level of protection against omicron as it did with earlier variants but longer duration of protection.”
The trial will involve 1,420 people aged 18-55.
A spokesperson for Pfizer told AFP that it did not include people older than 55 because the goal of the study was to examine the immune response of participants dosed, rather than estimate vaccine efficacy.
The volunteers are split into three groups.
The first involves people who previously received two doses of the current Pfizer-BioNTech vaccine 90-180 days prior to enrollment, and will receive one or two doses of the omicron vaccine.
The second will be people who got three doses of the current vaccine 90-180 days prior to the study and will receive either another dose of the original shot or an omicron-specific vaccine.
The third and final group are people who have never previously received a COVID-19 vaccine, and will receive three doses of the omicron-specific vaccine.
The Pfizer-BioNTech vaccine was the first COVID-19 shot to be authorized in the West, in December 2020.
Because it is based on messenger RNA technology, it is relatively easy to update to reflect the genetic code of new variants.
Several countries have begun to emerge from their latest waves driven by omicron, the most transmissible strain to date, even though global new cases are still rising.
The coronavirus has killed some 5.6 million people since the outbreak emerged in China in December 2019.
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Denmark to announce removal of all COVID-19 curbs: Report

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Denmark’s Prime Minister Mette Frederiksen is expected to announce on Wednesday the removal of all COVID-19 restrictions by the end of this month, daily Jyllands-Posten reported on Tuesday citing several sources.
Read the latest updates in our dedicated coronavirus section.
Denmark loosened restrictions two weeks ago after a month-long lockdown, allowing cinemas and music venues to reopen, but some rules remain, including limited opening hours for restaurants and mandatory face masks.
JP reported that the shift is based on recommendations from an expert panel that also recommends removing the classification of COVID-19 as a disease that is a critical threat to society, which has allowed the current restrictions.
The newspaper said Frederiksen was due to give a media briefing on Wednesday evening to make the announcement. Her office declined to comment on the report.
The Nordic country registered 40,348 new cases on Monday, down from a peak of 47,831 on Friday. The number of coronavirus-related hospitalisations rose to 894, the highest in a year.
But health authorities said it estimated between 30 percent-40 percent of those currently in hospital with a positive coronavirus test are there for other reasons than COVID-19.
Since a peak of 82 on Jan. 6, the number of COVID-19 patients in intensive care has fallen steadily to 43 on Monday.
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South Korea’s daily infections top 8,000 in a first driven by omicron

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South Korea’s daily new COVID-19 infections topped 8,000 for the first time on Tuesday, as the highly contagious omicron variant spreads rapidly, despite the extension of tough social distancing rules.
Read the latest updates in our dedicated coronavirus section.
The figure of 8,571 on Monday exceeded the previous peak of 7,848 in December, the Korea Disease Control and Prevention Agency (KDCA) said, as omicron became dominant in the country last week, though it is less deadly than previous variants.
Small business owners with shaven heads held a protest urging the government to lift the curbs, which include a 9 p.m. curfew for diners, as they sought compensation for losses.
“I haven’t been able to pay monthly rent, so I’m facing an eviction suit and have had to fire employees,” said Yang Hee-kyoung, one of the group of 300 protesters.
“I have no life,” added Yang, who runs a bar in the southern city of Busan.
Other demonstrators were tearful as they stood before a banner that sought “realistic compensation” for COVID-19 losses.
South Korea’s tough regimen of vaccine passes limits unvaccinated people to dining out alone, or making use of takeout or delivery services.
It reinstated tougher distancing curbs last month as record daily infections and critically ill patients threatened to swamp the medical system before omicron drove a rebound last week off daily tallies that almost halved to about 4,000.
The surge has fuelled worries about chances of a new wave of infections ahead of the Lunar New Year holiday that begins on Saturday, when tens of millions travel nationwide to meet families.
“It is no different from adding fuel to raging flames if many people move around the country and meet each other,” said Prime Minister Kim Boo-kyum, who has urged against travel and gatherings during the break.
Health officials said omicron would probably account for more than 90 percent of new infections within two to three weeks, while daily numbers could reach 20,000 to 30,000 or more.

From Wednesday, mandatory isolation for the vaccinated will be cut to seven days instead of 10, in a bid to free up resources for those who are critically ill.
The extended curbs triggered a backlash from small business owners, while a court ordered temporary exemption for teenagers and large stores from vaccine mandates in the capital, Seoul as a legal battle heats up between the government and citizens.
South Korea, with a population of 52 million, has a tally of 749,979 infections and a death toll of 6,588, in what has largely been a COVID-19 mitigation success story.
More than 95 percent of adults are fully vaccinated with nearly 58 percent having received a booster dose, KDCA data showed.
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