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Pfizer confirms experimental COVID pill appears effective against omicron variant

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.

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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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UAE reports 1,796 new COVID-19 cases, no deaths

The UAE announced 1,796 new COVID-19 cases on Saturday, the official Emirates News Agency reported.

This brings the current total active cases in the UAE to 17,551 and the total number of COVID-19 cases since the start of the pandemic to 949,384, according to data from the National Emergency Crisis and Disaster Management Authority (NCEMA).

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The cases were determined out of 232,943 tests in the last 24 hours.

No deaths from the virus were recorded on Saturday, maintaining the total deaths caused by COVID-19 to 2,317 in the UAE.

At least 1,727 patients recovered in the previous 24 hours, bringing the total COVID-19 recoveries to 929,516.

On June 13, the National Emergency Crisis and Disaster Management Authority (NCEMA) announced it would strictly enforce its mask rules – with penalties for those flouting the protocol – and announced it would tighten its rules on the Al Hosn green pass system amid rising coronavirus cases across the country.

NCEMA said that it has recently “monitored some behaviors that have become a danger to society and public health,” referring to people not adhering to COVID-19 precautionary and preventative measures and how it has “negatively” impacted recovery efforts.

“Negligence and recklessness in following precautionary measures, and failure in the societal role in maintaining public health and acquired immunity, has resulted in a rise in the number of infections and new waves of the virus,” the authority spokesman said in the briefing.

The authority reaffirmed the need to wear masks in closed public spaces, reiterating that it was mandatory and that not adhering to this rule would result in a fine of up to $816 (AED 3,000).

According to the World Health Organization, more than 4.1 million cases were reported globally in the last week.

It added, however, that the worldwide number of deaths remained relatively similar to the week before, at about 8,500, noting that COVID-related deaths increased in three regions: the Middle East, Southeast Asia and the Americas.

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Omicron-specific COVID-19 vaccines could increase protection as boosters: EMA

Coronavirus vaccines tweaked to include the omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday.
Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants.
While the existing coronavirus vaccines continue to provide good protection against hospitalization and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
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As such, an omicron-specific or bivalent booster – meaning a vaccine that includes both the new strain and the original coronavirus strain – could “increase and extend” protection, a statement from the EMA said.
The statement refers specifically to the mRNA vaccines. Both Pfizer Inc and Moderna Inc have been testing retooled versions of their vaccines to include the omicron variant.
Vaccines which include other variants, for example the beta variant, might also be considered for use as boosters if clinical trial data demonstrate an adequate level of neutralization against omicron and other variants of concern, the statement said.
It follows guidance from the World Health Organization that omicron-specific boosters could restore protection against emerging strains of the coronavirus.
But it stops short of the position of the regulator in the United States, the Food and Drug Administration (FDA), which said on Thursday that it would seek the inclusion specifically of the newer BA.4 and BA.5 strains of omicron, currently driving a surge in new infections globally, in any new shots for use domestically.
On Tuesday, the head of a WHO advisory committee that has considered the modified shots said the group preferred BA.1-based boosters, arguing that the variant is more distinct and could generate a broader response than the more recently circulating subvariants.
Top US FDA official Peter Marks said in an interview that regulators from other countries were seriously considering using new boosters based on the BA.1 omicron variant that caused the massive surge in cases last winter, because those shots can be available sooner than the BA.4/5 based booster the United States plans to use.
The EMA said it would provide more details in coming days.
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Russia scraps remaining COVID-19 restrictions

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Russia scraps remaining COVID-19 restrictions

Russia said on Friday it was ending all restrictions to combat the spread of COVID-19, including the requirement to wear masks, citing a steady decline in deaths from the virus.
However, it did not rule out re-introducing restrictive measures if the situation deteriorates.
Consumer watchdog Rospotrebnadzor said it was “suspending previously introduced restrictions, including the mask regime, a ban on public catering at night, and a number of other measures.”
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It said the dynamics of the virus were consistent with global trends and 93 percent of confirmed cases were mild or asymptomatic.
Since the start of the pandemic in Russia in April 2020, over 800,000 people have died from coronavirus or causes related to COVID-19, Reuters calculations show, with the country recording over 18 million infections.
Russia was quick to develop and launch its Sputnik V vaccine when the pandemic struck but take-up was slow, with many Russians citing distrust of the authorities and fear of new medical products. About 52 percent of the population has been fully vaccinated.
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