The U.S. is getting nearer to having an antiviral drug to assist deal with COVID-19 accessible, a growth specialists say can be game-changing in limiting the virus’ severity, particularly amongst aged and immunocompromised populations for whom vaccines are much less efficient.
Pfizer plans to finish two more studies of its antiviral therapy, Paxlovid, by the tip of the yr earlier than submitting the information to the U.S. Meals and Drug Administration. Preliminary information reveals the drug decreased the danger of hospitalization and loss of life by 89%.
In the meantime, Merck and Ridgeback have additionally utilized to the FDA for emergency use authorization for his or her capsule molnupiravir.
On Thursday, a British regulatory company advisable molnupiravir for these with delicate to average COVID-19 and a minimum of one threat issue for extreme sickness, making the nation the primary to approve a COVID-19 antiviral capsule.
Additionally within the information:
►Inexperienced Bay Packers quarterback Aaron Rodgers made his first public comments Friday after testing optimistic for COVID-19, addressing why he instructed the information media in August that he was “immunized” and why he isn’t vaccinated.
►States and cities, together with New York Metropolis, Chicago, San Antonio and Minnesota, are offering financial incentive for children to get vaccinated by way of $100 rewards and entry to scholarship raffles.
►Hoping to curb an increase in hostile passengers on planes, the Federal Aviation Administration introduced Thursday it has referred 37 instances of unruly passengers to the FBI for potential legal prosecution.
►Vaccine developer Novavax announced Thursday it has submitted its COVID-19 vaccine candidate to the WHO for emergency use itemizing as the corporate prepares to ship its vaccine globally.
📈 At present’s numbers: The U.S. has recorded 46 million confirmed COVID-19 instances and greater than 751,000 deaths, in accordance to Johns Hopkins University data. International totals: Greater than 248 million instances and 5 million deaths. Greater than 193 million People – 58% of the inhabitants – are absolutely vaccinated, in line with the CDC.
📘 What we’re studying: Pfizer’s COVID vaccine is now accessible for youths. Will schools require it?
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Dad and mom can go to the web site, kind of their zip code, click on a field specifying they’re in search of the Pfizer-BioNTech vaccine for ages 5 to 11 and instantly get an inventory of clinics, physicians and pharmacies which have the vaccine in inventory. The checklist will develop over time as extra websites open appointments.
On some websites, it will likely be potential to click on by way of and make an appointment on-line. On others, a telephone quantity can be listed to name for an appointment.
In contrast to the scramble adults confronted when photographs first turned accessible for them within the winter and spring, details about the place to get vaccination appointments for kids will be clear and updated, mentioned Dr. Dena Bravata, chief medical officer at Castlight Well being, the well being care navigation firm that runs the positioning.
“We have performed a number of pressure-testing of the system,” she mentioned. “We’re good to go.”
— Elizabeth Weise, USA TODAY
The place to get it, outcomes of examine:Everything to know about COVID-19 vaccine and children
Dad and mom of 11-year-olds:Here’s what experts say you should do about the COVID-19 vaccine
A wave of attorneys general in 11 states on Friday filed lawsuits towards the Biden administration over a brand new federal rule that will require large companies to vaccinate their workforce towards COVID-19 or implement rigorous testing regimes.
A lawsuit filed within the St. Louis-based eighth U.S. Circuit Courtroom of Appeals argues that states, not the federal authorities, has the authority to require vaccinations.
“This mandate is unconstitutional, illegal, and unwise,” mentioned the court docket submitting by Missouri Legal professional Normal Eric Schmitt. He mentioned he sued “to guard private freedoms, protect Missouri companies, and push again on bureaucratic tyrants who merely need energy and management.”
Whereas these lawsuits will doubtless make for good politics in crimson states the place federal mandates of any stripe are sometimes considered with skepticism, specialists say that whether or not they’ll make for good authorized challenges is a much more tough query to reply.
Companies with 100 or extra staff can be required to face up their vaccine-or-testing necessities by Jan. 4 or face stiff penalties below an emergency Occupational Security and Well being Administration rule made public Thursday. President Joe Biden said in September that his administration was engaged on the rule, so its unveiling this week was not a shock however did provide new particulars about its implementation.
— John Fritze, USA TODAY
The Meals and Drug Administration on Friday approved a brand new 15-minute at-home COVID take a look at from a California firm that may provide 50 million two-test kits per 30 days.
The iHealth COVID-19 Antigen Rapid Test doesn’t require a prescription and can be utilized by folks with or with out signs.
Sunnyvale, California-based iHealth Labs Inc. will promote the two-test package for $13.98. The corporate plans to quickly checklist promote the checks through Amazon and yet-to-be-named retailers, however the take a look at now may be bought at ihealthlabs.com, mentioned Sharon Fei, a iHealth Labs advertising supervisor.
iHealth may have the capability to distribute as much as 100 million two-test kits inside two months, if demand warrants.
People 15 or older can self-administer a single nasal swab take a look at inside the first seven days of COVID-19 signs. The take a look at additionally can be utilized for kids 2 or older if administered by a mother or father. Folks with out signs can take a look at themselves twice over three days with a minimum of 24 hours between the 2 checks, in line with the FDA.
As a result of house checks are self-administered, don’t require a prescription and are cheap, they’ve change into standard amongst individuals who don’t wish to hunt down lab checks that may take a day or two to ship outcomes. Two main house take a look at producers, Abbott and Quidel, slowed manufacturing in spring when COVID-19 instances considerably dropped. However the delta variant is driving a brand new surge in testing and producers once more elevated manufacturing.
– Ken Alltucker
As soon as the one American producer of the Johnson & Johnson vaccine, Emergent BioSolutions has misplaced its $628 million contract with the federal authorities after it spoiled 15 million doses of the Johnson & Johnson COVID-19 vaccine in April.
In accordance with The New York Times and Washington Post, the termination of the contract was disclosed Thursday by Emergent executives throughout a name with traders. Emergent said in a statement that it and the U.S. Division of Well being and Human Providers “mutually agreed” to finish the contract.
The federal government had already stopped making funds below the contract, which was created in Might 2020 and price over $600 million, the Instances reported. Emergent will surrender roughly $180 million of that quantity, in line with firm disclosures.
In April, the FDA issued a withering 13-page report about its Baltimore plant which mentioned it was too small, poorly designed and soiled. Inspectors noticed unsealed luggage of medical waste, peeling paint and broken flooring and partitions. Workers weren’t correctly educated and didn’t correctly deal with elements, the report says.
Europe and central Asia are as soon as once more on the epicenter of the pandemic as instances method document ranges throughout 53 international locations within the areas, the World Health Organization announced Thursday.
Final week, Europe and central Asia accounted for 59% of worldwide instances and 48% of deaths, in line with the WHO.
With 78 million reported instances, the European area now has extra instances than South East Asia, the Japanese Mediterranean, the Western Pacific and Africa mixed. Prior to now 4 weeks, Europe has seen a 55% enhance in new instances, and hospitalizations have greater than doubled up to now week, the WHO mentioned.
If numbers proceed to rise, the WHO tasks Europe and central Asia might even see one other half million COVID-19 deaths by subsequent February, and 43 international locations will face “excessive to excessive stress on hospital beds.”
In a Thursday assertion, Hans Henri P. Kluge, WHO regional director for Europe, pointed to inadequate vaccination charges and relaxed public well being measures as causes behind the surge.
“We’re at one other important level of pandemic resurgence,” Kluge mentioned. “Europe is again on the epicenter of the pandemic, the place we have been one yr in the past. The distinction at the moment is that we all know extra and we will do extra. We have now extra instruments and means to mitigate and cut back the injury to our communities and society.”
Many dad and mom and guardians are weighing the risks and benefits of getting their 11-year-old vaccinated now, or ready till their baby’s twelfth birthday once they can get the upper 30-microgram dose approved for adolescents.
However well being specialists say the decrease dose is probably going to provide the kids – whether or not they’re 11 or 12 – the identical safety towards COVID-19 as the upper one. They urge dad and mom and guardians to get their kids vaccinated as quickly as potential, particularly because the winter holidays deliver household gatherings that enhance the danger of coronavirus transmission.
“Delaying vaccination for a birthday to roll round doesn’t appear sensible,” Dr. Susan Coffin, a doctor on the Kids’s Hospital of Philadelphia’s division of infectious illnesses, mentioned throughout a media briefing Wednesday. “Any week that we delay vaccination, we’re rising the danger that our baby would possibly get an an infection, would possibly deliver an infection house or would possibly contribute to the unfold of an infection amongst their buddies.”
— Adrianna Rodriguez, USA TODAY
The Biden administration have new guidelines that requires many employers take a look at their staff for COVID-19 weekly if they refuse his vaccination mandate. The Occupational Security and Well being Administration guidelines introduced Thursday – which cowl an estimated 84 million folks – don’t require employers to pay for the tests.
The upshot is that People who decline to be vaccinated could possibly be compelled to pay the tab for his or her weekly screenings.
The presidential mandate comes because the U.S. economic system goes by way of a “Nice Resignation,” a document 4.3 million staff quitting their jobs in August for myriad COVID-19-related causes. Here’s what you need to know about how the testing alternative to vaccination could play out.
— Nathan Bomey, USA TODAY