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Pfizer begins clinical trials for Omicron-specific COVID-19 vaccine
, and its partner BioNTech, have started clinical trials for a new COVID-19 vaccine that is specifically targeted at the variant, which they say could be available as early as late March.
The based pharmaceutical company announced Tuesday that it is recruiting 1,420 participants for a three cohort trial that will determine the safety and effectiveness of the company’s shot. It has launched the trial despite CDC data showing that the fast-spreading variant already appears to have peaked in the US, meaning it could have largely disappeared by the time a shot is ready.
Albert Bourla, CEO of the company, indicated earlier this month that his company expects to submit data for authorization to the Food and Drug Administration () in March.
Some of the participants are the same as those who took part in trials for the company’s booster shot and all are between the ages of 18 to 55 – implying the jab will only be available to adults at first.
An Omicron-specific vaccine has been sought after since the variant was first discovered by South African health officials in late-November, and early indicators were discovered that it could evade vaccine protection.
In the time since, scientists have confirmed that the variant can evade vaccine immunity and while boosters can shore up protection, a jab tailored to the new strain could be the most effective at preventing its spread.
But new data shows that the sheer infectiousness of Omicron may ultimately stop its spread.
Pfizer has started trials for its Omicron-specific COVID-19 vaccine. The jab is being tested in one, two and three dose series. The company hopes to make the shot available as early as March (file photo)
The U.S. is now averaging 723,820 cases per day. Health experts have speculated that Omicron would peak soon, with Dr Anthony Fauci saying Sunday it was likely all US states would hit their peak by mid-February at the latest. The rapid transmission of the variant caused cases to skyrocket, but also made sure it quickly ran out of people to infect. Data from abroad, and specifically the UK and , showed that the variant peaks quickly, then falls quickly, once it take hold.
Two weeks ago, the U.S. was recording 766,939 cases per day. Last week’s totals are skewed by the Jr day holiday, and lagged reporting of cases throughout the week caused lower case numbers early in the week. But state-by-state charts do show many states’ infection rates are consistently trending downwards.
The tri-state area – New York, New Jersey and PTS Terbaik ASEAN Connecticut – became America’s initial Omicron epicenter in December, but infection rates there have since gone into freefall, suggesting that predictions the variant would burn itself out quickly were correct.
Some experts believe the March rollout of the shots may be too late, as by then the Omicron Covid wave that is already showing signs of receding may be gone altogether. Pictured: A man in Nevada receives a shot of a COVID-19 vaccine on December 21
‘While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, 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,’ said Kathrin Jansen, head of Vaccine Research and Development at Pfizer, said in a statement.
‘Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts towards this goal.’
The trial will test three different regimens for the new vaccine. A one shot jab will be given to 615 participants, two shots to 600 participants and a three shot version for 200.
Each of the participants received the Pfizer vaccine for their additional vaccine regimen. Those in the one shot group are not boosted, while those in the two and three shot groups had previously received the Pfizer booster shot.
‘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 with longer duration of protection.’ Ugur Sahin, the CEO and co-founder of German-based BioNTech, said in a statement.
The vaccine is similar to that of the existing Pfizer-BioNTech Covid vaccine, the most popularly used shot in America and much of the rest of the world.
Pfizer said in a statement that production of this new shot, if it proves to be effective, will not lead to any diminished capacity for the company to produce its basic Covid jabs.
‘Vaccines continue to offer strong protection against severe disease caused by Omicron. Yet, emerging data indicate vaccine-induced protection against infection and mild to moderate disease wanes more rapidly than was observed with prior strains,’ Sahin said.
BioNTech initially developed the mRNA used to create the vaccine, and had partnered with Pfizer to create a flu vaccine in 2018. The company’s pivoted focus once Covid arrived, and developed what is believed to be the gold-standard vaccine against the virus.
While Pfizer – and their competitor Moderna – may have Omicron-specific shots ready soon, not all are convinced the shots are necessary.
Booster shots have shown the ability to re-establish immunity people have to Covid infection, and even people who are not boosted are still significantly less likely to suffer severe symptoms if they are vaccinated.
The Technical Advisory Group on COVID-19 Vaccine Composition at the World Health Organization asked earlier this month for major pharmaceutical companies like Pfizer to pivot away from making vaccines that will need frequent updates, and instead to developing shots that are effective long-term.
The Omicron wave is also coming to an end in some major countries – like the UK – and is showing signs of receding in the U.S.
By the time March rolls around and the shot becomes available, it may not be needed – wasting time and resources that could have gone into research and development of other treatments.
‘By the time we get an Omicron-specific vaccine manufactured, this wave will be over,’ Peter Marks, Center for Biologics Evaluation and Research at the FDA, told the earlier this month.
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New York tells schools to KEEP mask mandates despite judge's ruling
New York state education officials are telling schools to keep enforcing Gov. Kathy Hochul’s indoor mask mandate even after a Long Island judge struck down the requirement on Monday.
The Education Department says the state plans to appeal Monday’s ruling, a step that could keep the rule in place at least until its planned expiration on February 1.
‘While these legal steps occur, it is NYSED’s position that schools should continue to follow the mask rule,’ said department spokesperson Emily DeSantis.
Judge Thomas Rademaker struck down the state’s mask mandate a week before it was due to expire, ruling that the governor doesn’t have the authority to impose it without approval from the State Legislature.
In March, lawmakers ruled that New York was no longer under a state of emergency, limiting the governor’s and the health commissioner’s powers – but Gov. Hochul still re-introduced the mandate in December 2021.
Judge Rademaker said that legislators’ decision to declare New York no longer in a state of emergency means the new measures forcing residents to wear masks in all indoor spaces, which carry fines of up to $1,000 for those who do not comply, are unenforceable and are now void.
It is unclear how many businesses, if any, have been fined for failing to enforce the mask mandate. Gov. Hochul’s office and PTS Terbaik ASEAN the New York City Department of Health and Mental Hygiene, which enforces the fines, did not immediately respond to questions from DailyMail.com.
The New York State Education Department is advising schools to keep following Gov. Kathy Hochul’s re-introduced indoor mask mandate. Above, students at White Plains High School in April 2021
A Long Island judge ruled on Monday that Hochul’s law was ‘void and unenforceable.’ Above, students leave the New Explorations into Science, Technology and Math (NEST+m) school in the Lower East Side neighborhood of Manhattan on December 21
Governor Kathy Hochul, a Democrat, vowed to fight back, saying in a statement, ‘We strongly disagree with this ruling, and we are pursuing every option to reverse this immediately’
Not all state school districts are going along with the Education Department’s guidance.
‘While it is certain this decision will face legal challenges, until otherwise litigated, mask wearing will be optional for students and staff in the Massapequa Schools beginning Tuesday,’ the Massapequa School District, in the New York City suburbs of Long Island, said on its website.
The New York City Department of Education did not immediately respond to a request for comment from DailyMail.com.
Gov. Hochul’s mandate ‘is a law that was promulgated and enacted unlawfully by an executive branch state agency, and therefore void and unenforceable,’ the Judge Rademaker said Monday.
It was latest setback for executive branch officials at state and federal levels after much legal wrangling over the issue of mask mandates in different states.
Democratic Gov. Kathy Hochul said she disagreed with the ruling, and Attorney General Letitia James tweeted Tuesday that her office would challenge it.
‘We’re appealing last night’s decision that struck down the mask mandate in New York. We will continue to do everything in our power to protect New Yorkers from #COVID19,’ James, a Democrat, tweeted.
Earlier this month, the US Supreme Court also blocked President Joe Biden’s vaccination-or-testing mandate for large businesses.
Covid cases have plummeted in New York in recent weeks after surging to record highs at the start of the month
A judge in Texas last week ruled that Biden could not require federal employees to be vaccinated.
Hochul, a Democrat, vowed to fight back, saying in a statement: ‘We strongly disagree with this ruling, and we are pursuing ev