Quid-Pro-Cuomo? Sexual Harassment Probe Eyes Whether Governor's Office Traded Vax Access For Political Support

 The sexual harassment investigation against New York Governor Andrew Cuomo (D) has widened in scope, as the state AG's office has begun looking into whether a top Cuomo adviser linked access to COVID-19 vaccines with political support for the governor, according to the Wall Street Journal, citing people familiar with the matter.

At least three Democratic county executives who say they were surprised at phone calls from Larry Schwartz, a volunteer adviser who oversaw vaccine distribution for the state - who asked the top Democrats whether they would call for Cuomo's resignation. Schwartz contacted over a half-dozen executives in early March as Cuomo faced mounting calls for his resignation from members of his own party - and had been personally contacting state lawmakers to affirm their support.

One county executive filed a complaint in March over a call from Schwartz, according to people familiar with the matter.

"Right at the time that every county was working, and desperately needed more vaccines, to receive a call from the person who was responsible for allocating those doses gauging political loyalty to the governor was an obvious conflict, and at best ethically gray," said the executive.

The executives said that at the time of Mr. Schwartz’s calls they were typically speaking with him about the allocation of vaccine supplies, not politics.

Mr. Schwartz has said he didn’t link vaccine distribution to political considerations. On Friday, he referred questions to his lawyer, Guy Petrillo, who declined to comment.

Mr. Schwartz, an executive at an airport-concession company, resigned from his post as the state’s vaccine czar last week after state lawmakers changed lobbying rules for nonpaid state advisers. Under the new rules, Mr. Schwartz would have been banned for two years from lobbying the governor’s office if he had stayed on in the role. -Wall Street Journal

The AG's investigation is one of several ongoing probes into Cuomo and his administration. Most notably, the US Attorney's Office for the Eastern District of New York is looking into the Governor's COVID-19 policies - including nursing home deaths during the pandemic after Cuomo ordered COVID-positive patients to be housed alongside the most vulnerable population.

Cuomo, meanwhile, is also under investigation over accusations of sexual misconduct by multiple women.

"I’ve already told New Yorkers where I am. I did nothing wrong, period. And I‘m not resigning, and I’m doing my job every day," said Cuomo.

https://www.zerohedge.com/political/quid-pro-cuomo-sexual-harassment-investigators-looking-whether-governors-office-traded

BioNTech says 'no evidence' its jabs need adapting for variants

 German firm BioNTech said Monday that the COVID-19 vaccine it developed with Pfizer does not require any modifications to work against variants of the virus, as it announced new plans to ramp up production of the jabs.

"To date, there is no evidence that an adaptation of BioNTech's current COVID-19 vaccine against key identified emerging variants is necessary," the company said in a statement.

Nevertheless, in preparations for a need at some point to make tweaks to its current vaccine, the company said it began tests in March on a "modified, variant-specific version" of its jabs.

"The aim of this study is to explore the regulatory pathway that BioNTech and Pfizer would pursue if SARS-CoV-2 were to change enough to require an updated vaccine," it said.

An assessment is also ongoing on whether a possible third dose could prolong immunity and protect against variants.

BioNTech chief executive Ugur Sahin had said in April that the vaccine works against the Indian variant.

The jab developed by BioNTech/Pfizer was the first to win authorisation in the West, and has since been deployed in dozens of countries worldwide.

It is now supplying more than 90 countries worldwide, and is expecting to ramp up its production to up to three billion doses by the end of the year from 2.5 billion doses expected previously.

'More than enough vaccines'

BioNTech said in a separate statement Monday that it was setting up a production facility in Singapore—its first outside Europe—to produce hundreds of millions of mRNA-vaccines a year.

The island nation will also host the company's Southeast Asia headquarters.

BioNTech's partner Pfizer operates production sites in the United States as well as in Belgium.

In a bid to rapidly raise global production capacities to cope with huge global demand for their COVID vaccine, BioNTech and Pfizer have set out licensing and manufacturing partnerships with other pharmaceutical companies such as Merck, Novartis and Sanofi.

The latest of such cooperations involves a unit of China's Shanghai Fosun Pharmaceutical, which has agreed a $200 million joint venture with BioNTech to make coronavirus vaccines.

Fosun said late Sunday that the joint venture firm for manufacturing and commercialising the vaccines will be owned 50 percent by each company.

Both BioNTech and Pfizer have argued that the extension of such cooperation is what would help ensure a wider supply of vaccines, and not a patent waiver as the United States has sought.

Reiterating the argument, Sahin told journalists Monday that BioNTech believes that "together with other vaccines developers, in the next 9 to 12 months there will be more than enough vaccines produced".

"There is absolutely no need for waiving patents," he said.

Amid the huge demand for its vaccines, BioNTech said its first quarter profits soared to 1.1 billion euros ($1.3 billion), compared to a 53.4 million euros loss in the same period last year.

Revenues reached 2.0 billion euros for the quarter ending March, compared to 27.7 million euros year-on-year.

It added that estimated revenues from COVID vaccines upon delivery of currently signed contracts of around 1.8 billion doses would reach 12.4 billion euros.

https://medicalxpress.com/news/2021-05-biontech-evidence-jabs-variants.html

Ask the Pediatrician: How do COVID-19 vaccines work, and are they safe for teens?

 Q: How do the COVID-19 vaccines work, are they safe for teens, and how long will immunity last?

A: COVID-19 vaccines are authorized for those ages 16 and older at this point and are expected to be available for children ages 12 and up soon. Here are several important things to know about the vaccines.

The COVID-19 vaccine works similarly to other vaccines your child has had. Germs such as SARS-CoV-2, the virus that causes COVID-19, invade and multiply inside the body. The vaccine stops this by helping the immune system make special proteins called antibodies to fight the virus. After vaccination, your child has less of a chance of getting COVID-19. And if your child does get infected with the virus, they may not be as sick as without the vaccine.

Three vaccines have been given emergency use authorization by the U.S. Food and Drug Administration so far. Two require two doses (Pfizer and Moderna), and one involves a single shot (Johnson & Johnson). Distribution of the one-shot vaccine was paused to look for possible ties between it and some extremely rare, but serious blood clots reported during the vaccine's safety monitoring process. It now is being administered again.

The COVID-19 vaccines that require two doses are both messenger ribonucleic acid (mRNA) vaccines. The other was developed as a "viral vector" vaccine. They all have the same result—protecting people from COVID-19—but their delivery systems are a bit different.

COVID-19 mRNA vaccines carry instructions to our cells to produce harmless pieces of "spike" protein found on SARS-CoV-2. This triggers an immune system response that the body remembers if the virus ever invades.

Although this technology has been studied for decades, widespread use of mRNA vaccines is new. They don't use the live coronavirus that causes COVID-19. The mRNA in the vaccine gets into the cells where the shot is given. Then it gives the cells instructions on how to create a piece of protein that is found on the virus that causes COVID-19.

Once the protein is created, your immune system identifies it as a foreign molecule. The immune process starts, making antibodies that can attach to the protein. These antibodies protect you from getting COVID-19.

Viral vector vaccines, like the mRNA vaccines, also give instructions to your immune cells. Instead of carrying the instructions to your cells on a fat bubble, as with the mRNA vaccine, they are carried in a harmless virus (not the coronavirus that causes COVID-19).

The same process happens as with the mRNA vaccine—the cells create the protein that's found on the virus that causes COVID-19, the immune system makes antibodies to fight it, and you're protected from getting COVID-19.

Before getting FDA authorization, clinical trials showed COVID-19 vaccines to be remarkably safe and effective for adults and teens ages 16 and up. Trials for each of the vaccines involved tens of thousands of volunteers.

Clinical trials for younger children are ongoing. One of the vaccine makers has asked for FDA approval to include children as young as age 12. Clinical trials are expected to begin soon in children as young as 6 months old.

The vaccines continue to be monitored very closely. The Centers for Disease Control and Prevention say COVID-19 vaccines will have "the most intensive safety monitoring in U.S. history."

Scientists don't know for certain how long immunity from the vaccine will protect people. But people are likely to need a third dose of a COVID-19 vaccine within a year of getting fully vaccinated and may need annual shots to protect against the virus, Pfizer CEO Albert Bourla said in April.

It takes about two full weeks after getting the second dose of the mRNA vaccines for your body to build up an immunity to the virus that causes COVID-19. For the one-dose vaccine, building up immunity takes two to four weeks.

Currently, the Pfizer vaccine is approved for teens who are 16 or 17, and it's set to be approved for ages 12-15. And remember, COVID-19 vaccines are free, whether or not you have health insurance.

https://medicalxpress.com/news/2021-05-pediatrician-covid-vaccines-safe-teens.html

Chemocentryx’s future in doubt as avacopan foundation crumbles

 After Friday’s split adcom vote on Chemocentryx’s avacopan in ANCA-associated vasculitis, even the sellside seems to have given up on the project’s prospects of approval. And a glance at the group’s pipeline shows little else to get excited about. Avacopan’s chances in hidradenitis suppurativa and C3 glomerulopathy look like a long shot after mid-stage failures last year; Chemocentryx also has plans in lupus, historically a graveyard for biopharma. And any future successes might be tempered by concerns raised by the FDA about avacopan’s liver toxicity. So what next for Chemocentryx? The company did not mention its phase 1 asset CCX507 in its latest earnings release, focusing instead on the preclinical oral checkpoint inhibitor CCX559; however, others like Curis have been working on oral projects for some time now with little progress. Even if Chemocentryx prevails here the PD-(L)1 field is crowded, and bigger players are already developing more convenient options, such as Pfizer with its subcutaneous asset sasanlimab. Chemocentryx’s share price plunged 62% on Friday but, with a valuation still well above its $424m cash balance, there are some hopes that the group can pull a rabbit out of the hat.

Chemocentryx's pipeline
Project	Description	Indication	Status	2026e sales ($m)
Avacopan (Vynpenta)	Complement factor C5a inhibitor	ANCA-associated  vasculitis	FDA adcom split 9-9 on whether efficacy data support approval; Pdufa July 7	348
		Hidradenitis suppurativa	Failed ph2 Aurora trial but planning ph3 in severe pts	63
		C3 glomerulopathy	Failed ph2 Accolade trial but discussing path forward with FDA	24
		Lupus	Development to start Q4 2021	-
CCX507	CCR9 inhibitor	Ulcerative colitis	Ph1	-
CCX559	Oral PD-L1 inhibitor	Cancer	Preclinical; ph1 to start Q2 2021	-
CCX587	CXCR6 inhibitor	Autoimmune diseases	Preclinical	-
Source: Evaluate Pharma & company presentations. https://www.evaluate.com/vantage/articles/news/snippets/chemocentryxs-future-doubt-avacopan-foundation-crumbles

Novavax delays COVID vax production timeline, sees filing for authorization in Q3

 Novavax Inc said on Monday production of its COVID-19 vaccine will ramp up at a slower pace than it had previously anticipated and it does not expect to file for regulatory authorization in the United States, Britain or Europe until the third quarter of 2021.

Novavax said it does not expect to hit its production target of 150 million shots per month until the fourth quarter of 2021, later than its previous goal of the third quarter. It had also previously said it could be authorized in the United States as early as May.

The U.S. company has repeatedly pushed back its production timeline and has said it is struggling to access raw materials and equipment needed to manufacture its vaccine. Shares fell 3% in after hours trading after closing nearly 9% lower on Monday.

Novavax’s shot has yet to be authorized by regulators in any country, but it has reported late-stage data from a UK trial that shows it to be highly effective against the original version of the coronavirus and a newer, more contagious variant first found in Britain. 

Data from its pivotal U.S. and Mexico trial is expected to be released in the current quarter.

While vaccine demand is declining in the United States, the Novavax shot is expected to play an important role in global inoculation efforts, with many countries such as India and much of South America desperate for supplies.

“Unmet demand outside of the United States has resulted in continued demand for Novavax’s vaccine,” said Chief Commercial Officer John Trizzino.

The company has committed to supply 200 million shots to countries around the globe, in addition to the 1.1 billion doses it has committed to the COVAX international vaccine sharing program, Trizzino said.

Novavax reported a net loss for the first quarter of $223 million. It had $447 million in revenue, mostly payments from the U.S. government for its COVID-19 vaccine research, and spent $593 million on research and development.

https://www.reuters.com/article/novavax-results/update-2-novavax-delays-covid-19-vaccine-production-timeline-sees-filing-for-authorization-in-3rd-qtr-idUSL4N2MX44W

FDA authorizes emergency use of Pfizer, BioNTech COVID vaccine to kids 12-15

 The U.S. Food and Drug Administration late Monday authorized the emergency use of Pfizer Inc. PFE, +0.71% and BioNTech SE BNTX, +10.15% COVID-19 vacccine for children between the ages of 12 and 15. Acting FDA commissioner Janet Woodcock called the expansion of the emergency use a "significant step in the fight against the COVID-19 pandemic." The FDA had granted the vaccine emergency use for people 16 and older. "Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," she said. From March 2020 through April 2021, about 1.5 million COVID-19 cases in kids 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention, the FDA said.

https://www.marketwatch.com/story/fda-authorizes-emergency-use-of-pfizer-biontech-covid-vaccine-to-kids-12-15-2021-05-10

FDA meeting on COVID-19 vaccines in kids on June 10

 The Food and Drug Administration (FDA) announced a June 10 advisory committee meeting to discuss COVID-19 vaccines in pediatric populations amid speculation that the agency would decide on Pfizer-BioNTech’s request to expand emergency use authorization (EUA) for its shot to teens ages 12-15 within the coming days.

The memo was sent just two days before the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is set to meet, although as of Monday there was no draft agenda for the meeting available on the agency's website.

It was widely believed that the FDA would issue a decision on Pfizer-BioNTech's request early this week, with Dr. Anthony Fauci speculating that the agency would take "several days" to respond to the companies' request. It was not clear if the announcement of the June 10 meeting would impact the agency's plans regarding a decision. 

"Vaccines continue to be an important public health measure in fighting the COVID-19 pandemic," said Dr. Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research. "To date, the FDA has authorized three COVID-19 vaccines for emergency use that have met our rigorous standards for quality, safety and effectiveness -- two are authorized for individuals 18 and older, and one is authorized for individuals 16 and older.

"We recognize that the next critical step is having vaccines available for use throughout the pediatric population," Marks continued. "As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range." 

https://www.foxnews.com/health/fda-meeting-covid-19-vaccines-kids-june-10