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Wednesday, February 17, 2021

Pfizer, BioNTech to Supply EU With Additional 200 Million Covid-19 Vaccine Doses

 Pfizer Inc. and BioNTech SE said Wednesday that they have entered into an agreement with the European Commission to supply additional 200 million doses of their jointly-developed Covid-19 vaccine.

Under the agreement, the additional doses are expected to be delivered in 2021, with an estimated 75 million doses to be supplied in the second quarter, the companies said. The European Commission has the option to request an additional 100 million doses, they said.

The new agreement comes in addition to the first supply agreement for 300 million doses which was signed in 2020. It now brings the total number of doses to be supplied to EU member states by 2021 to 500 million--extendable to 600 million if the additional doses are requested.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-BioNTech-to-Supply-EU-With-Additional-200-Million-Covid-19-Vaccine-Doses-32459655/

Biophytis Expands Recruitment for Part 2 of Phase 2-3 COVA Trial in France and Belgium

 

  • Clinical centers in France and Belgium will begin recruitment for Part 2 of the COVA Study following authorization from Regulatory Authorities

  • These approvals follow the previous authorizations obtained from Brazil and the United States in most clinical centers

  • Interim Analysis of Part 1 is expected in Q1 2021

  • Results from the full study (Part 1 and Part 2) are expected in Q2 2021

Biophytis SA (NasdaqGS: BPTS; Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, today announces that patient recruitment will begin in France and Belgium for Part 2 of its COVA Study assessing Sarconeos (BIO101) as a potential treatment for acute respiratory failure associated with COVID-19.

https://finance.yahoo.com/news/biophytis-announces-expansion-patient-recruitment-070000288.html

Novartis, Gates Foundation collaborate on therapy for sickle cell disease

 Novartis has entered into a grant agreement with the Bill & Melinda Gates Foundation to fund the development of accessible single use gene therapies to cure sickle cell disease (SCD), the pharmaceuticals company said on Wednesday.

The project aims to address disparity in access to treatments and prioritize populations and regions that bear the greatest burden of the hereditary blood disease, Novartis said.

Around 300,000 people are born with the condition annually. Sub-Saharan Africa is particularly badly affected by SCD, which reduces the ability of red blood cells to transport oxygen and can be fatal.

https://www.reuters.com/article/us-novartis-gates-sicklecell/novartis-and-bill-melinda-gates-foundation-collaborate-on-therapy-for-sickle-cell-disease-idUSKBN2AH0LQ

NY attorney general sues Amazon over COVID-19 shortfalls

 New York Attorney General Letitia James sued Amazon.com Inc on Tuesday over its handling of worker safety issues around the COVID-19 pandemic at two warehouses, just days after the retailer filed its own lawsuit seeking to block her case.

In a complaint filed in a New York state court in Manhattan, James said Amazon’s drive for faster growth and higher profits led to its “flagrant disregard” of steps needed to protect workers from the coronavirus at a Staten Island fulfillment center and a Queens distribution center, both in New York City.

James also accused Amazon of illegally retaliating when employees began to complain, including last March when it fired activist Christian Smalls purportedly for violating a paid quarantine when he led a protest over conditions at the Staten Island warehouse.

“Throughout the historic pandemic, Amazon has repeatedly and persistently failed to comply with its obligation to institute reasonable and adequate measures to protect its workers,” the lawsuit said.

“Amazon has cut corners in complying with the particular requirements that would most jeopardize its sales volume and productivity rates,” it added.

James sued four days after Amazon filed its own lawsuit in Brooklyn federal court to stop her from suing.

Amazon said in its lawsuit that federal labor and safety laws took precedence over New York’s in addressing workplace safety, and that James was overstepping her authority.

”We care deeply about the health and safety of our employees, as demonstrated in our filing,” Amazon spokeswoman Kelly Nantel said in response to James’ lawsuit.

“We don’t believe the Attorney General’s filing presents an accurate picture of Amazon’s industry-leading response to the pandemic,” Nantel added.Amazon also faced scrutiny last March when workers protested conditions at the Staten Island warehouse. New York City announced its own probe at the time.

The attorney general’s lawsuit seeks to require Amazon to upgrade its protections for workers, reinstate Smalls, and pay damages to him and another worker who allegedly faced retaliation.

https://www.reuters.com/article/us-amazon-com-complaint/new-york-attorney-general-sues-amazon-over-covid-19-shortfalls-idUSKBN2AH0C2

Taiwan says BioNTech vaccine deal on hold, cites potential Chinese pressure

 A deal for Taiwan to buy 5 million doses of a COVID-19 vaccine developed by Germany’s BioNTech SE is on hold, the island’s health minister said on Wednesday, citing potential Chinese pressure for the delay.

Taiwan Health Minister Chen Shih-chung said officials were on the verge of announcing the deal in December when BioNTech pulled the plug.

While he did not directly say China was to blame, Chen implied there was a political dimension to the decision and that he had been worried about “outside forces intervening”, hence his caution in discussing the planned deal publicly.

“Certain people don’t want Taiwan to be too happy,” he added, without elaborating, in a radio interview.

China, which claims Taiwan as its own territory, has repeatedly sparred with the island over the coronavirus pandemic.

Taiwan has been angered by China’s assertion only it can speak for the island on the international stage about the subject, while Taiwan has accused China of lack of transparency.

BioNTech signed a deal with Chinese firm Shanghai Fosun Pharmaceutical Group Co Ltd to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan.

In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.

BioNTech’s development and distribution partner for the rest of the world is U.S. firm Pfizer Inc.

Chen said BioNTech had not asked them to speak to Fosun, and the deal with BioNTech had not been “torn up”, only that it was “pending”.

BioNTech and Fosun did not immediately respond to a request for comment. China’s Taiwan Affairs Office declined immediate comment. China is currently observing the week-long Lunar New Year holiday.

Taiwan announced late in December said it had agreed to buy almost 20 million doses of COVID-19 vaccine, including 10 million from UK drugmaker AstraZeneca, with the rest coming from the COVAX global vaccine programme and an unnamed company.

https://www.reuters.com/article/us-health-coronavirus-taiwan/taiwan-says-biontech-vaccine-deal-on-hold-cites-potential-chinese-pressure-idUSKBN2AH0HE

Tuesday, February 16, 2021

S. Africa restarts its vaccine drive as first country to use the J&J shot

 South Africa is poised to achieve a milestone in the worldwide response to the coronavirus pandemic when it becomes the first country to administer a Covid-19 vaccine created by the pharma giant Johnson & Johnson (J&J) this week.

Developed by Janssen, J&J’s vaccine-making subsidiary, the vaccine has shown in human trials to be highly effective at preventing severe illness from a variant of the virus that emerged in South Africa in December, and has since appeared in at least 32 countries. The country hit hardest by the coronavirus on the continent, South Africa has experienced 1.5 million cases of Covid-19 and at least 48,000 deaths since last March.

J&J is awaiting approval of its vaccine in several countries, including the US, which is expected to rule on the company’s request later this month.

The rollout of the J&J vaccine in South Africa marks a pivot by public-health officials, who had planned this week to begin vaccinating the country’s estimated 1.5 million frontline health-care workers with a jab developed by Oxford University and AstraZeneca. Officials paused the rollout of the AstraZeneca vaccine and recalibrated their plans based on preliminary, limited evidence that raised questions about the ability of the AstraZeneca vaccine to protect against severe illness from the 501Y.V2 variant, as the local strain is known.

To get the J&J jab into arms, South Africa will redeploy up to 500,000 doses that the company had set aside for global clinical trials, which showed the vaccine to be nearly 90% effective in preventing severe illness from Covid-19 caused by the 501Y.V2 variant. Health officials plan to administer the shots to health-care workers at 16 hospitals that J&J had used to test its vaccine in South Africa. Regulators approved the so-called “early-access” program on Friday.

“It’s incredible that we can switch so quickly,” Glenda Gray, president of the South African Medical Research council and a co-principal investigator of the J&J vaccine trial, said on Tuesday. “We were going to start the AstraZeneca program on Monday, and we are announcing the initiation of an alternative program to start the same week, which I think is phenomenal. The shift to the J&J was an important decision, because it’s the only vaccine that we knew would help against hospitalization and death.”

Officials say they expect J&J to deliver the vaccine, which will ship in vials that hold two doses apiece, to South Africa at a rate of 80,000 doses every two weeks. Besides sourcing doses of the J&J vaccine from early-access supply, South Africa also has agreed to purchase 9 million doses. The J&J vaccine requires just one jab and can be stored in standard refrigerators, avoiding the need for workers to return for a second shot and making the vaccines the easiest the Covid-19 vaccines developed so far to distribute.

Health-care workers who want to receive the jab are required to register via a national health department website that will establish their eligibility and send them a text message with details of when and where to get vaccinated. At least 28% of eligible workers, or roughly 351,000 people, had registered for a shot as of Monday afternoon. Gray says that officials hope to vaccinate workers 10 hours a day, seven days a week.

The deputy director general of South Africa’s national health department said on Tuesday that South Africa planned to try to recoup its investment in 1.5 million doses of the AstraZeneca vaccine that the government purchased from the Serum Institute of India. That may include sharing at least 1 million doses with other countries in the African Union. The shot remains a viable vaccine for countries that are not contending with the 501Y.V2 variant, according to the World Health Organization.

In addition to the J&J vaccine, South Africa also plans to rely for its first phase of vaccinations on a Covid-19 jab jointly developed by Pfizer and BioNTech. That vaccine has shown in laboratory studies to also offer a high degree of protection against the 501Y.V2 variant. Cyril Ramaphosa, South Africa’s president, said last week that the country anticipates delivery of 20 million doses of the double-dose Pfizer shot, enough to cover 10 million people, or roughly 25% of the nearly 40 million people the country plans to vaccinate, by April.

Ramaphosa added that the country expects to receive an allotment of vaccines through both the global Covax initiative and the African Union, and is continuing discussions with vaccine makers with the aim of purchasing additional doses.

The government has said it plans to acquire enough vaccines to immunize two-thirds of South Africa’s population of 58 million by the end of this year with the goal of achieving herd immunity.

https://qz.com/africa/1973285/south-africa-to-be-first-to-use-johnson-johnson-covid-19-vaccine/

Crippling storm hampers vaccinations as FEMA opens new sites

 A paralyzing winter storm wrought havoc with COVID-19 vaccination efforts around the country on Tuesday, forcing the cancellation of appointments and delaying vaccine deliveries just as the federal government rolled out new mass vaccination sites aimed at reaching hard-hit communities.

FEMA opened its first COVID-19 inoculation sites in Los Angeles and Oakland, part of a broader effort by the Biden administration to get shots into arms more quickly and reach minority communities hit hard by the outbreak.

The developments came as the vaccination drive ramps up. The U.S. is administering an average of nearly 1.7 million doses per day, according to the Centers for Disease Control and Prevention.

And the administration said Tuesday it was boosting the amount of vaccine sent to states to 13.5 million doses per week, a 57% increase from when President Joe Biden took office nearly a month ago, as well as doubling to 2 million the weekly doses being sent to pharmacies.

At the same time, coronavirus deaths are down sharply over the past six weeks, and new cases have plummeted.

Snow, ice and bitter cold forced authorities to halt vaccinations from Pennsylvania to Illinois and from Tennessee to Missouri. In snowy Chicago, Public Health Commissioner Dr. Allison Arwady said more than a hundred city vaccine sites didn’t get shipments Tuesday because of the extreme weather, leading to many cancellations.

The Biden administration said the weather was expected to disrupt shipments from a FedEx facility in Memphis and a UPS installation in Louisville, Kentucky. Both serve as vaccine shipping hubs for a number of states.

In Texas, Houston’s Harris County rushed to dispense more than 8,000 doses of Moderna’s coronavirus vaccine after a public health facility lost power early Monday and its backup generator also failed, authorities said. The shots at risk of spoiling if not given out were distributed at three hospitals, the county jail and Rice University.

“It feels amazing. I’m very grateful,” said Harry Golen, a 19-year-old sophomore who waited for nearly four hours with his friends, much of it in the frigid cold, and was among the last people to get the shots — which otherwise wouldn’t have reached students until March or April.

More than 400,000 additional doses due in Texas now won’t arrive until at least Wednesday, officials said.

Geisinger, one of Pennsylvania’s largest health systems, canceled vaccine appointments scheduled for Wednesday and Friday at several locations after the CDC told state health officials that shipments would be delayed because of severe weather.

Vaccine shipments were also delayed in Ohio and in Missouri — where snow, ice and bitter cold forced cancellation of mass inoculation events scheduled for this week.

In California, though, two new FEMA sites began mass vaccinations. In the early morning in Los Angeles, several dozen cars were already lined up with people sitting inside, reading newspapers and passing the time, a half-hour before the 9 a.m. opening of the nation’s first site run with assistance from the Federal Emergency Management Agency.

Troops in camouflage fatigues stood around the sprawling parking lot at California State University, Los Angeles, where some 40 white tents were erected and dozens of orange cones put in place to guide traffic.

The site, set up in heavily Latino East L.A. as part of an effort to reach communities that have suffered disproportionately during the crisis, aims to vaccinate up to 6,000 people a day. Another site opened at the Oakland Coliseum, near working-class Black and Latino neighborhoods.

Hard-hit California has overtaken New York state for the highest death toll in the nation, at over 47,000.

The Los Angeles site is “proximate to a community that has been disproportionately impacted by this pandemic,” Gov. Gavin Newsom said. “The effort here is to address that issue forthrightly.”

The Biden administration plans to establish 100 federally assisted vaccination sites nationwide in cooperation with state authorities.

Elsewhere around the country, the virus put a big damper on Mardi Gras in New Orleans. The French Quarter’s Bourbon Street, where the rowdiest partying usually takes place, was blocked off with police barricades. Bars were ordered closed, a year after Mardi Gras crowds were blamed for a severe outbreak of COVID-19 in Louisiana.

“It’s hard to wrap my head around it,” New Orleans lawyer Dave Lanser, wearing a luminescent green cape and a black mask with a curved beak, said as he looked up and down a nearly empty Bourbon Street. But “I don’t think there’s a way to safely do it this year,” he said. “So, I support canceling the parades, closing the bars, all that kind of stuff.”

Nearly 39.7 million Americans, or about 12% of the U.S. population, have received at least one dose of the vaccine, and 15 million have gotten both shots, the CDC said.

Deaths are running at about 1,700 per day on average, down by more than 1,600 (or almost 49%) from their peak in mid-January. And the average number of new cases per day has dropped to about 85,000, the lowest in 3 1/2 months. That’s down from a peak of almost a quarter-million per day in early January. The overall U.S. death toll is at nearly 490,000.

Still, some public health experts warn it’s far too early to declare the virus is on the wane. For one thing, they are worried about the more contagious variants that are taking hold.

Dr. Ronald Hershow, director of epidemiology at the University of Illinois-Chicago School of Public Health, predicted there will be upticks.

“Honestly, I would be surprised if we can point to this recent downturn as the moment in time where we turn the corner and everything’s downhill from here,” he said.

https://apnews.com/article/fema-opens-mass-vaccination-sites-4cd95c115ac455169b63ae109d179f4a