EU drugs agency says it is advising makers of Russian vaccine

 The European Medicines Agency (EMA) is in the process of offering advice to the developers of the Russian Sputnik V COVID-19 vaccine, but is not currently reviewing it for approval, the agency’s chief said on Tuesday.

EMA provides scientific advice to drug developers designed to ensure trials are performed efficiently and to the highest standards.

The agency has authorised two vaccines, one developed by Pfizer and BioNTech and another from Moderna, and is expected to clear an AstraZeneca vaccine developed with Oxford University on Friday.

It is also conducting a rolling review of a possible vaccine from Janssen, but with no timetable for its evaluation, EMA Executive Director Emer Cooke said.

“We’ve been in contact with at least 15 developers so far and this includes the Russia-developed Sputnik vaccine, which is in the context of scientific advice procedure,” Cooke told a committee of the European Parliament.

She said it should be made clear that EMA had not received an application for rolling review or market authorisation for the Sputnik vaccine.

“They have raised a number of questions with us ... and this will obviously shape how the evaluation could go forward in the future,” she said.

Russia’s sovereign wealth fund, RDIF, said last week that it had filed for registration of the Sputnik vaccine in the European Union and expected it to be reviewed in February.

Cooke said EMA had also been in touch with about 180 developers of COVID-19 therapeutics, with some likely to seek EMA approval later this year.

“We have hundreds of thousands of Europeans who have become infected with the virus and many have been made severely ill so we need therapeutic options that can treat these patients and avoid longer term health consequences as much as possible,” she said.

https://www.reuters.com/article/us-health-coronavirus-ema-vaccines/eu-drugs-agency-says-it-is-advising-makers-of-russian-vaccine-idUSKBN29V22Q

'Low COVID-19 spread' found in schools taking safety precautions: U.S. study

The spread of COVID-19 during in-person learning in rural Wisconsin where student mask wearing was high was significantly lower than in the surrounding community, with no infections acquired at school among staff members, according to a U.S. study published on Tuesday.

That COVID-19 incidence in the 17 elementary through high schools was 37% lower than in the community suggests schools could safely open with the right precautions in place, researchers concluded in the report published by U.S. Centers for Disease Control and Prevention (CDC).

“Given the findings of our data set, with proper precautions such as distancing and wearing face coverings, it seems that adult school staff members are unlikely to contract COVID-19 in the classroom,” study author Amy Falk, from the Aspirus Hospitals and Clinics, said in an emailed response.

CDC scientists in a separate article published in JAMA also supported the reopening of schools provided social distancing and mask-wearing measures are implemented.

While there had been some evidence of in-school transmission, "the preponderance of available evidence from the fall school semester has been reassuring," they said.(bit.ly/3a69ZOn)

“As many schools have reopened for in-person instruction in some parts of the U.S. as well as internationally, school-related cases of COVID-19 have been reported, but there has been little evidence that schools have contributed meaningfully to increased community transmission,” the CDC said.

In the Wisconsin study, just seven of 191 cases (3.7%) identified among 5,530 students and staff members during the period of Aug. 31 to Nov. 29, 2020, were associated with in-school transmission, all in students, researchers reported.

“The absence of identified child-to-staff member transmission during the 13-week study period suggests in-school spread was uncommon,” the researchers said, despite up to a 40% positive COVID-19 test rate in the surrounding county.

Social distancing was required and mask-wearing was reported at more than 92%. Classes were taught in stable cohorts with both lunch and classes taking place indoors. Lunch took place mainly in the cafeteria, in assigned cohorted groups for ease of contact tracing. But no systematic COVID-19 screening was conducted in the schools or the community.

The researchers found widespread virus transmission in the surrounding community during the study period, with 7% to 40% of COVID-19 tests from Wood County showing positive results.

COVID-19 incidence among students and staff members in the study translated into 3,453 cases per 100,000 in schools versus 5,466 per 100,000 in the wider community.

The schools in the study included eight elementary schools(grades K–6) with 1,529 students attending in-person, and nine middle or high schools (grades 7–12) with 3,347 students attending in-person.

Limits to the study published in the CDC’s Morbidity and Mortality Weekly report, included that researchers did not check for asymptomatic transmission and that not all teachers reported mask wearing levels.

https://www.reuters.com/article/us-health-coronavirus-usa-education/low-covid-19-spread-found-in-schools-taking-safety-precautions-u-s-study-idUSKBN29V2CD

Pfizer working on booster shot to protect against COVID-19 variants

 Pfizer Inc said on Tuesday that along with partner BioNTech Se it was developing a booster shot to protect against COVID-19 variants.

“We are already laying the groundwork to respond quickly if a variant of SARS-CoV-2 shows evidence of escaping immunity by our vaccine,” Pfizer said in an email to Reuters.

However, the company added that studies needed to evaluate the booster shot are yet to be determined in agreement with regulators.

Moderna Inc, whose vaccine has also been authorized for emergency use in the United States, had said on Monday it would test a new booster shot aimed at the South African variant of the coronavirus after concluding the antibody response could be diminished.

https://www.reuters.com/article/us-health-coronavirus-pfizer-vaccine/pfizer-working-on-booster-shot-to-protect-against-covid-19-variants-idUSKBN29V1ZU

US to purchase 200M more vaccine doses

 The Biden administration will purchase 200 million more coronavirus vaccines and funnel more to states now, in a bid to deliver on the U.S. president’s promise to curb the pandemic, a senior administration official said on Tuesday.

Biden, who took office last week, is in a race to contain the virus as faster-spreading variants threaten to increase the death toll across the United States, which has already been hard-hit.

The administration is briefing state governors on Tuesday about its plans to increase the amount of the vaccine going to those local governments to 10 million doses per week for the next three weeks, up from 8.6 million currently, according to the official who declined to be named, who previewed a policy the president has not yet discussed.

The administration will purchase 100 million doses each of the vaccines made by Pfizer Inc and Moderna Inc, increasing the overall total doses to 600 million, with delivery expected by summer. Each vaccine requires two doses per person to be fully effective, suggesting the new purchases would cover most of the country’s 331 million people.

The administration also promised to provide notice to the states three weeks in advance of how much vaccine they would be getting in the future.

Biden made management of the pandemic a core issue in his presidential election campaign, but in its early days, the administration has sent mixed messages about when exactly the vaccines will be fully administered.

On Monday, Biden said he believed it was possible to have 150 million doses of the vaccine administered in his first 100 days in office, an aspiration his press secretary Jen Psaki said was not an official adjustment of the current target of 100 million doses over that same time period.

“The president and his team have been working around the clock over the past six days to make meaningful progress on vaccinating as many people as possible,” she said.

https://www.reuters.com/article/us-health-coronavirus-usa-biden/biden-administration-to-purchase-millions-more-vaccine-doses-to-curb-virus-idUSKBN29V28C

Governors Told Weekly Vaccine Allocations to States to be Hiked

Senior Biden administration officials told U.S. governors on Tuesday that the administration is increasing its weekly vaccine allocations to states, according to people with knowledge of the matter.

On a call with governors Tuesday afternoon, officials said they planned to increase the allocations by 16% to about 10 million doses a week from about 8.6 million, the people said. Of that, 5.7 million doses will be Moderna Inc.'s vaccine and 4.3 million will be Pfizer Inc.'s vaccine, the people said.

In a bid to give the states certainty and allow them to better plan, the officials said they would provide the increased doses for at least three weeks, one of the people said.

The White House didn't immediately provide comment on the call.

The call with governors included remarks from Centers for Disease Control and Prevention Director Rochelle Walensky and White House coronavirus coordinator Jeffrey Zients, the people said.

https://www.marketscreener.com/quote/stock/MODERNA-INC-47437573/news/Moderna-Biden-Administration-Officials-Told-Governors-They-Will-Increase-Weekly-Vaccine-Allocation-32281514/

Biden to Launch Health-Care Agenda

 President Biden on Thursday will begin shaping his health-care agenda by lifting certain restrictions on abortion funding and relaunching Affordable Care Act insurance sign-ups, moving swiftly to reassemble components of the health law weakened by the former Trump administration, according to a person familiar with the planning.

Mr. Biden will sign executive orders directing the reopening of enrollment on the ACA's federal exchanges and rescinding a Trump administration policy that blocked federal funds to nongovernmental agencies that provide abortion counseling or referrals, the person said.

Mr. Biden will also initiate a review of a Trump administration decision that cut off federal funding for family-planning organizations such as Planned Parenthood Federation of America, the person said. The Trump administration cut off funding to organizations that refer patients for abortions, and Planned Parenthood left the program known as Title X. An action related to Medicaid, a federal-state program for low-income and disabled people, is also expected.

While Mr. Biden agreed with some of Mr. Trump's health-care initiatives, such as ending surprise medical billings and some antitrust actions to curb market concentration in the industry, the actions coming Thursday are aimed at unraveling his predecessor's stamp on health care. The moves are spurring criticism from conservative and antiabortion groups that have opposed the ACA and lauded restrictions on federal funding for abortion.

Mr. Trump had pledged to repeal the ACA and replace it with a better alternative but failed to do either. He supported key parts of a lawsuit from a coalition of Republican-led states to invalidate the ACA, which the Supreme Court is weighing.

Sen. John Barrasso (R., Wyo.), the chairman of the Senate Republican Conference, criticized the Obama administration's ACA implementation, while adding that Mr. Biden's health-care plans would "make people pay more and wait longer for worse care." He also voiced concern over the flurry of executive orders Mr. Biden has signed since taking office last week.

"I'm just concerned that Joe Biden is doing a number of things with executive orders across the board," Mr. Barrasso said Tuesday. "The president is certainly not acting like somebody who is looking for unity and wants to work in a bipartisan way."

The abortion policy on nongovernmental agencies is known as the Mexico City policy, referring to the city where it was announced in 1984 by Ronald Reagan, who first instituted it. The policy, dubbed the "global gag rule" by critics because it restricts organizations that seek U.S. funding from dispensing abortion information, has been reversed and reinstated in successive Democratic and Republican administrations.

The Trump administration said Mr. Trump's decision to reinstate the policy in January 2017 was a reflection of his views on abortion.

Mallory Quigley, vice president of communications at Susan B. Anthony List, a nonprofit antiabortion advocacy group, criticized the move as Mr. Biden's payback to abortion providers for campaign donations. "It is also a slap in the face to the majority of Americans who do not want their tax dollars sent to abortion businesses, and especially not to abortion promoters overseas," she added.

The Biden administration's actions had been widely expected. Dr. Anthony Fauci last week previewed the rescinding of the abortion rule in remarks before the World Health Organization. Health-care advocates had expected the reopening of open enrollment under the ACA for health insurance and say they also expect Mr. Biden to provide more funding for outreach and marketing of the plans.

A number of Democrats had unsuccessfully urged the Trump administration to extend the ACA's open enrollment period, which ended Dec. 15, because of the pandemic.

The plan to expand the enrollment period was first reported Sunday by the Hill, a political-news publication.

Any effort to boost sign-ups would require outreach funding, health analysts say. The Trump administration cut funding for those efforts by 90%.

Health-advocacy groups and Democrats say the coming signing of the executive orders indicates that Mr. Biden can and will use regulation and guidance to shore up the ACA even if Congress doesn't take action. Democrats have a razor-thin margin in the House, and the Senate is evenly split, though Vice President Kamala Harris can break any tie votes.

Mr. Biden played a key role in getting the ACA passed and campaigned on expanding the law, resisting calls from progressives to embrace Medicare for All, the single-payer health-care proposal championed by Sen. Bernie Sanders (I., Vt.). Mr. Biden called for both expanding federal subsidies and eligibility requirements for Medicare.

Mr. Biden has also proposed for the federal government to subsidize insurance for some people in states that didn't expand Medicaid by automatically enrolling them in a federal public option resembling Medicare.

During arguments before the Supreme Court in November over the lawsuit seeking to invalidate the health law, several conservative Supreme Court justices joined liberals voicing skepticism that the entire Affordable Care Act must fall, suggesting the law may survive its latest test in the high court.

Mr. Biden has promised to bolster access to health care regardless of the outcome of the case.

"We're going to do everything in our power to ease the burden of health care on you and your families," Mr. Biden said in November, "to flesh out the details so that we can hit the ground running: tackling cost, increasing access, lowering the price of prescription drugs. Families are reeling right now."

The actions planned Thursday also indicate that Mr. Biden intends to advance a double-barreled approach of ramping up federal action on combating coronavirus while also strengthening the health law. He could seek to reverse work requirements in Medicaid and offer enticements to get more states to expand the program, restrict enrollment in health plans that don't comply with the law, and strengthen benefits that must be covered by health plans under the ACA.

"It's two-pronged. The Biden administration is moving full steam ahead on health care as well as Covid and not waiting for Congress to act," said Larry Levitt, executive vice president for health policy with the Kaiser Family Foundation. "He has full authority to reverse everything the Trump administration did on health care, and more."

https://www.marketscreener.com/quote/stock/UNITED-PARCEL-SERVICE-IN-14758/news/Biden-to-Launch-Health-Care-Agenda-2nd-Update-32281828/

Selecta upped to Buy from Neutral by Mizuho

 Target to $8 from $2.50

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