Pfizer, J&J balk at shareholder push for COVID-19 vaccine pricing info

 What's the rationale behind COVID-19 vaccine and drug prices? You don’t have a need to know—or so say a couple of the leading contenders. 

Two major players in the pandemic fight, Pfizer and Johnson & Johnson, are urging the Securities and Exchange Commission (SEC) to forestall shareholder resolutions that would require them to disclose how they set prices on their COVID-19 vaccines.

Several not-for-profit groups are pushing the two companies—along with fellow pharmas Eli Lilly, Gilead, Merck & Co. and Regeneron—for information on their drug and vaccine pricing decisions, citing the federal money all have received, either for supplies, R&D or manufacturing scale-up. Or all three.

The Interfaith Center on Corporate Responsibility (ICCR) said in early December that it had filed shareholder proposals with all six of those companies. The goal of the ICCR according to its announcement was to “learn how the companies will price COVID medicine developed with public monies.”

In similarly-worded letters to the SEC, first reported by Newsweek, Pfizer and Johnson & Johnson both contend that they don't need to put those resolutions to a shareholder vote, saying their “ordinary business operations” should be exempt from shareholder oversight.

The U.S. government has awarded contracts that total more than $10 billion. Pfizer agreed to provide 200 million vaccines for $19.50 per dose, or $3.9 billion. Johnson & Johnson signed on for 100 million doses at $10 each. Nearly a year ago, Johnson & Johnson also won $465 million in federal funding for vaccine R&D—bringing its U.S. funding total to almost $1.5 billion. Regeneron agreed recently to a deal that could bring the company as much as $2.6 billion, depending on how quickly it can produce its antibody cocktail.

ICCR says Pfizer and J&J are making "unsubstantiated" arguments to avoid a shareholder vote on the pricing-information proposals. Access to COVID vaccines "transcends ordinary business," said Meg Jones-Monteiro, health equity director of the ICCR, a coalition of 300 faith communities and other organizations that use investments as levers for social change.

“It’s been proven in past SEC decisions that pricing and access is really a social policy issue," Jones-Monteiro said in an interview. "And in the context of COVID, it’s even more problematic that they’re using that as a reason to exclude this proposal from their proxy."

Both pharmaceutical companies also referred to the shareholder proposal as an attempt to “micromanage,” which Johnson & Johnson characterized as “probing too deeply into matters of a complex nature upon which shareholders, as a group, would not be in a position to make an informed judgment.”

But Jones-Monteiro says ICCR isn't asking for "specific algorithms" or details on how the companies determine pricing. She said she expects a decision from the SEC later this month.

“Our ask is: Have you taken into account the public investment?” she said. "Have you taken that into account and how have you taken it into account?’ When you look at the disclosures both companies have, they don’t reference that.”

Nicholas Lusiani of Oxfam America, a member of the ICCR, stated the case for the public interest group in its proposal announcement. The group doesn't just want info on the companies' rationale, but on what they'll do with the proceeds.

“We want to understand the extent to which any profits derived from the public investment will be reinvested to further critical scientific agenda versus, for example, to pay dividends to shareholders, which doesn’t advance the public health goals these public investments are intended to facilitate," Lusiani said.  

Jones-Monteiro said that there’s more to the public investment than the dollar amounts paid by the government. Consider the Pfizer and Moderna vaccines, both developed with the mRNA technology provided by the National Institutes of Health.   

“When you think about this concept of public support, it’s not just about the investment in R&D initially, but it’s also the technology that was developed with public support, public funding, academic support.” 

This isn't the first time ICCR has demanded sensitive information from top pharma companies. Most recently, the organization put forth proxy proposals that would force disclosures about executive pay. The resolutions, which went up for a vote at annual shareholder meetings, asked the drugmakers whether they use price increases to meet their sales goals, whether boards must approve price hikes and more. 

https://www.fiercepharma.com/pharma/pfizer-johnson-johnson-balk-at-shareholder-requests-for-vaccine-pricing-info

Could combining Pfizer's, AZ's COVID vaccines fill supply gaps? UK researchers aim to find out

 Given that the COVID-19 vaccines from Pfizer and AstraZeneca each require one dose, followed a few weeks later by a booster shot, could the two products be used interchangeably?

That’s the question researchers from the Oxford Vaccine Group have set out to answer with a new clinical trial designed to address a mounting problem: The demand for COVID vaccination in many locales around the world is far outstripping the supply.

Oxford’s 13-month study will recruit more than 800 volunteers in England, who will receive one of four different combinations of the vaccines. Half the participants will get two doses of the same vaccine, while the others will receive one dose of either the Pfizer or AstraZeneca vaccine, followed by a booster of the other company’s product.

The researchers will use blood samples taken at various intervals to monitor patients’ immune responses, while also recording any adverse reactions that occur. They believe the data they collect will help policymakers decide whether they can adopt mix-and-match strategies to address supply shortfalls and other logistical challenges, as well as the changing nature of the COVID-19 virus.

“If we do show that these vaccines can be used interchangeably in the same schedule this will greatly increase the flexibility of vaccine delivery, and could provide clues as to how to increase the breadth of protection against new virus strains,” said chief investigator Matthew Snape, associate professor at the University of Oxford, in a statement. AstraZeneca is partnered with Oxford in developing its shot.

“There are no data available on the interchangeability of Pfizer-BioNTech’s vaccine (BNT162b2) with other COVID-19 vaccines to complete the vaccination course,” a Pfizer spokesperson said in an emailed statement, adding that anyone who already received one dose of its vaccine should get the same shot as a booster.

AstraZeneca did not immediately respond to a request for comment from Fierce Pharma.

The Oxford trial is launching just days after AstraZeneca proposed a solution of its own to address the vaccine supply constraints. Last week, CEO Pascal Soriot told reporters that the European authorization of his company’s vaccine specifies that the booster shot can be given as long as 12 weeks after the initial dose.

In fact, data released earlier this week showed that when people received the second shot of AstraZeneca’s vaccine 12 weeks after the first, the efficacy rate was 82.4%, versus 54.9% in those who got the booster within six weeks.

Soriot suggested the data supported a strategy of using all available doses of AstraZeneca’s vaccine and not stockpiling any booster shots because the company should be able to fill any supply gaps within 12 weeks.

Pfizer and BioNTech, meanwhile, have brought in some support to ramp up the production of its mRNA vaccine. Last month, Novartis agreed to produce the Pfizer/BioNTech COVID shot at one of its Swiss manufacturing facilities starting in the second quarter. Deliveries of the vaccines produced there should start in the third quarter, Novartis said. That deal followed a similar agreement with French drugmaker Sanofi, which also has separate development deals with GlaxoSmithKline and Translate Bio.

Pfizer’s vaccine uses mRNA technology, while AstraZeneca’s is a modified viral vector, so the Oxford team hopes the new trial will also provide some clues as to how a combination of the two technologies might work against fast-spreading mutant strains of COVID-19.

Many COVID vaccine makers have launched their own investigations to try to determine just how effective their shots are against the new variants. Pfizer scientists, working with a team at the University of Texas, released a study showing the company’s vaccine could neutralize an engineered version of the mutant virus spreading through the U.K. and South Africa

But not everyone is convinced the data are conclusive. Evercore ISI told its clients last week that Pfizer’s analysis failed to include some of the mutations found in the South Africa coronavirus variant, making it a less-than-comprehensive study. SVB Leerink analysts griped that vaccine makers are testing their products against the new variants with assays that have not been adequately validated.

AstraZeneca isn’t taking any chances with the newly emerging COVID-19 strains. It is now working with Oxford to develop a next-generation version of its vaccine that’s designed to neutralize new variants and that could be available next fall, an executive said during a press briefing, according to Reuters.

https://www.fiercepharma.com/pharma/could-combining-pfizer-s-and-az-s-covid-19-vaccines-fill-supply-gaps-uk-researchers-set-out

Roche hit by $5.6B worst-case biosim assault as COVID-19 hurts new hit Ocrevus

 Before biosimilars to Herceptin, Avastin and Rituxan arrived in the U.S., Roche laid out an estimated range of potential damage to its business. By the look of its first post-biosim year, the company was hit with its worst-case scenario.

Biosimilars to the three cancer megablockbusters in the U.S., EU and Japan put a CHF 5.05 billion ($5.62 billion) dent in Roche’s top line in 2020, the company said Thursday. The worldwide loss was about CHF 5.7 billion.

“We’ve seen the worst that it can get—the impact was bigger than certainly our base case,” Roche’s pharma chief Bill Anderson said during a conference call with investors.

The U.S. market contributed a large share of the decline, especially given that Herceptin and Rituxan copycats had already been on the European market for some time. In the U.S., Avastin sales dropped 37% in 2020 to CHF 1.80 billion, Rituxan fell by 32% to CHF 2.86 billion, and Herceptin by 47% to CHF 1.36 billion.

The drop was also bigger than industry watchers had expected; none of the three drugs’ global sales met analysts’ consensus.

For 2021, the absolute reduction will be milder at roughly CHF 4.6 billion ($5.1 billion) globally, Anderson added. That may sound like a positive turn, but it’s much larger than the CHF 3.57 billion analysts at Jefferies had modeled, which they noted was already above consensus expectations.

It also looks more severe if we put this into the perspective of Roche’s historical forecast. By what Roche called a “conservative” erosion from biosims, the company had in 2019 projected a CHF 9.6 billion gap between 2018 and 2023 sales for the three drugs. Anderson’s numbers now indicate that the drugs will have crossed that threshold by 2021.

Roche has traditionally pointed to new drugs to back up its confidence that the company will grow through the biosimilar attack. But COVID-19 derailed that plan, at least for the pharma business, in 2020.

Multiple sclerosis drug Ocrevus dethroned Avastin as Roche’s best-selling drug beginning in the third quarter of 2020. But its 17% year-over-year annual growth was significantly slowed by COVID-19, which dragged its CHF 4.48 billion ($4.98 billion) haul below the Street’s consensus. The reported growth level was partially hurt by a strong Swiss franc; at constant currencies, Ocrevus’ increase amounted to 24%.

Ocrevus was attracting high levels of patients switching from another MS drug up to the first quarter of 2020. Then came the pandemic, and switching slowed dramatically, Anderson said. Because Ocrevus targets B cells and is injected by a healthcare professional, some existing patients became nervous about whether to get a dose out of concerns that the therapy might hurt their immune system’s strength against the novel coronavirus—or that going into a therapy center could increase their chance of infection.

In the third quarter, some of the patients who delayed their doses came back, Anderson said. But because Ocrevus is dosed every six months, the Q2 drop also extended to Q4. The rate of switching is still significantly below pre-pandemic levels—at 40% in October by Roche’s market research. So this cycle of quarterly sales fluctuations will probably continue for years to come, Anderson warned.

Whatever increases Ocrevus and other newer drugs such as Tecentriq and Hemlibra pulled off, they were not enough to turn Roche pharma’s 2020 into a sales-positive year. Overall, Roche’s pharma sales came in at CHF 44.53 billion ($49.53 billion) down by 8% year over year, or 2% at unchanged exchange rates.

https://www.fiercepharma.com/pharma/roche-hit-by-worst-case-scenario-biosim-assault-as-covid-19-hurts-new-king-ocrevus

WHO inspector 'has conflict of interest in Wuhan COVID probe'

 A prominent molecular biologist at Rutgers University claims that a member of the World Health Organization (WHO) team investigating the origins of COVID-19 in Wuhan has a conflict of interest, due to his ties with the Wuhan lab at the center of the inquest.

British zoologist and the president of EcoHealth Alliance Peter Daszak is the only individual to be part of both the WHO and The Lancet teams investigating the origins of the Wuhan coronavirus pandemic. However, he has long-term professional and financial ties with the Wuhan Institute of Virology (WIV), which represents a conflict of interest.

Richard H. Ebright is the Board of Governors Professor of Chemistry and Chemical Biology at Rutgers University, and Laboratory Director at the Waksman Institute of Microbiology. He told Taiwan News that Daszak is the contractor who funded the WIV's research on bat SARS-related coronaviruses, with subcontracts of $200 million in USAID funding and $7 million in NIH funding.

Ebright said that Daszak is a collaborator on the WIV research for bat SARS-related coronaviruses. He lamented that the WHO named Daszak as a member of its review team, and The Lancet named Daszak as the head of its review team. Ebright said this makes "it clear that WHO and Lancet reviews cannot be considered credible investigations."

In addition to the funding EcoHealth Alliance receives from USAID, NIH, and other agencies, which it funnels into the WIV, Ebright stated the firm received US$30 million from the US Department of Defense.

When asked whether Daszak had been involved in the controversial gain of function experiments on bat coronaviruses at the WIV, Ebright said: "Daszak has been a contractor, a collaborator, and a co-author on work at the WIV on construction and analysis of novel chimeric coronaviruses."

A report by Independent Science News and a search of U.S. government databases revealed that EcoHealth Alliance received US$39 million in funding from the Pentagon from 2013 to 2020. Adding another US$64.7 million from USAID, the report found that Daszak's "non-profit organization" has raked in over US$103 million from the U.S. government.

Since 2014, Daszak's organization has funneled some of this U.S. government funding into the WIV to carry out research on bat coronaviruses. In the first phase of research, which took place from 2014 to 2019, Daszak coordinated with Shi Zhengli (石正麗) — also known as "Bat Woman" — at the WIV to investigate and catalog bat coronaviruses across China. EcoHealth Alliance received US$3.7 million in funding from the NIH for this research, and 10 percent was channeled to the WIV, reported NPR.

Shi Zhengli (center) and Peter Daszak (far right). (Emerging Viruses Group photo)

The second phase, which started in 2019, involved gain-of-function (GoF) research on coronaviruses and chimeras in humanized mice from the lab of Ralph S. Baric of the University of North Carolina. In a video interview originally recorded on Dec. 9, 2019, Daszak mentioned the testing of modified coronaviruses on human cells and humanized mice in the WIV, just weeks before the first cases of COVID-19 were announced in the city of Wuhan, China.

Daszak has dismissed the possibility of a lab leak, insisting since the start of the pandemic it's a "conspiracy theory" — without providing evidence for his claim. A report by U.S. Right to Know alleges that emails released through freedom of information requests reveal that Daszak persuaded 26 prominent scientists to sign a statement published in The Lancet on Feb. 19 2020, claiming that any suggestions that COVID-19 was not of natural origin are "conspiracy theories."

Four signatories of The Lancet statement are employed by EcoHealth Alliance. Six scientists who signed the statement, including Daszak, now comprise half of The Lancet's panel investigating the origins of the virus.

Furthermore, Daszak in 2015 co-authored an article in the journal Nature titled, "Spillover and pandemic properties of zoonotic viruses with high host plasticity," in which he stated that zoonotic virus spillover from wildlife was "most frequent" in a number of settings and occupations, including "laboratory workers." He also warned that laboratories are one of the most dangerous settings for major spillover events.

"Among all high risk interfaces and hosts, only viruses transmitted to humans by contact with wild animals in the wildlife trade and in laboratories ... were more likely to have broader geographic reach," Daszak said.

Daszak's colleague, Shi Zhengli, in 2010 published a paper describing a scenario in which infected rodents led to a deadly virus being leaked from a Chinese lab. The paper, titled, "Hantavirus outbreak associated with laboratory rats in Yunnan, China," detailed an outbreak of hantavirus hemorrhagic fever with renal syndrome (HFRS) at a college in Kunming as the result of a lab leak in 2003.

Since the start of the pandemic, both Daszak and Shi have denied that a lab leak occurred at the WIV. However, over a year since the outbreak, Shi has yet to provide independent investigators with access to the WIV's database and laboratory records.

Daszak has yet to respond to a request to comment on allegations that he has a conflict of interest in the WHO and The Lancet investigations. The WIV has also yet to reply to questions about their experiments in 2019.

https://www.taiwannews.com.tw/en/news/4119101

Palihapitiya-backed Clover Health plunges as short-seller Hindenburg weighs in

 Noted short-selling specialist Hindenburg Research published a critical report of Chamath Palihapitiya-backed Clover Health Investments Corp on Thursday, sending the insurance firm’s down more than 10%, its biggest daily percentage drop in four months.

Venture capital investor Palihapitiya, who held a 27% stake in Clover Health as of Jan. 7, was among the big financial names to support last week’s GameStop buying frenzy against institutional short-sellers, saying early in the slugfest that he had bought in to the video game retailer.

The Hindenburg report hindenburgresearch.com/clover, the title of which called Clover Health a "broken business," risks reheating the battle between hedge fund short-sellers and investors.

Clover Health said it would be issuing a statement in the next few hours to address the claims made by Hindenburg. Neither Palihapitiya nor his representative immediately responded to a Reuters request for comment.

Hindenburg said in the report that it had no investment position in Clover Health.

Citron, another of the financial world’s famous short-selling research houses, said last week it would no longer publish reports recommending shorts.

Clover, which sells Medicare-backed insurance plans, went public through a $3.7 billion deal with a special purpose acquisition company (SPAC) backed by Palihapitiya. Its other investors had included Alphabet Inc and Sequoia Capital.

Palihapitiya’s SPAC raised $720 million in April 2020 and six months later announced the tie-up with Clover.

In recent months, the popularity of using SPAC’s has exploded among startup companies who want to avoid the more traditional route of using an initial public offering to enter the market.

Clover shares closed down 12.33% at $12.23, the biggest daily percentage drop since Oct. 6. Volume in the session topped 68 million units, by far the most active trading day in the stock’s history and well above its 10-day average of about 14.4 million.

Shares of Clover had fallen 16.8% so far this year before Thursday’s tumble.

In September, Hindenburg issued a report on Nikola Corp calling it an “intricate fraud built on dozens of lies.” Shares of the electric truck maker have fallen about 35% since the report.

In a Dec. 15 report, Hindenburg said it remained short on Loop Industries with a $0 price target. Shares of Loop have climbed nearly 50% since.

https://www.reuters.com/article/clover-health-short-seller/update-4-palihapitiya-backed-clover-health-plunges-after-short-seller-hindenburg-weighs-in-idUSL4N2KA3NP

Sana Biotech valued at over $6 billion in market debut

 Shares of gene-regulation startup Sana Biotechnology Inc surged 40% in their U.S. stock market debut on Thursday, giving the Seattle-based company a market capitalization of $6.38 billion.

It offered 23.5 million shares in its initial public offering (IPO) on Wednesday, raising about $587.5 million in what was the largest-ever IPO for a preclinical biotech company.

The company’s shares opened at $35, well above the IPO price of $25 per share.

Sana, founded in 2018, is led by several co-founders of another Seattle-based biopharmaceutical company, Juno Therapeutics, which is a unit of Bristol-Myers Squibb Co.

The biotech firm has raised a total of around $865 million in funding so far from investors including venture capital firm Arch Venture Partners and Canada Pension Plan Investment Board, according to data from PitchBook.

Morgan Stanley, Goldman Sachs, J.P. Morgan and BofA Securities were the lead underwriters for the offering.

https://www.reuters.com/article/sana-biotech-ipo/sana-biotech-valued-at-over-6-bln-in-market-debut-idUSL4N2KA49K

J&J asks emergency authorization from FDA for Covid vaccine

 Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus.

If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”

U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J’s vaccine, which could happen as early as this month. President Joe Biden is trying to pick up the pace of vaccinations in the U.S. and experts say his administration will need an array of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans over the last year, according to data compiled by Johns Hopkins University.

Unlike Pfizer’s and Moderna’s vaccines, which require two doses given about three to four weeks apart, J&J’s medication only requires one dose, easing logistics for health-care providers.

J&J said on Jan. 29 that its vaccine was 66% effective overall in protecting against Covid-19. The vaccine, however, appeared to be less potent against other variants. The level of protection was just 57% in South Africa, where a new, highly contagious strain called B.1.351 is rapidly spreading. South Carolina officials detected the first-known U.S. case of that strain last month.

Infectious disease experts point out that J&J’s numbers can’t be used as a direct comparison with Pfizer’s and Moderna’s vaccines, which were found to be 95% and 94% effective, respectively. That’s because J&J’s vaccine is a single dose and the company’s trial was conducted when there were more infections and new, more contagious variants, they said.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the most crucial finding of the J&J data was the vaccine appeared to be 85% effective in preventing severe disease.

“The most important thing, more important than whether you prevent someone from getting aches and a sore throat, is preventing people” from getting severe disease, the director of the National Institute of Allergy and Infectious Diseases said on a call with reporters on Jan. 29. “That will alleviate so much of the stress and human suffering and death in this epidemic.”

The FDA has indicated it would authorize a vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the Centers for Disease Control and Prevention.

J&J has said it plans to ship the vaccine at 36 to 46 degrees Fahrenheit. By comparison, Pfizer’s vaccine needs to be stored in ultra-cold freezers that keep it between negative 112 and negative 76 degrees Fahrenheit. Moderna’s vaccine needs to be shipped at between negative 13 and 5 degrees Fahrenheit.

The Department of Health and Human Services announced in August that it reached a deal with Janssen, J&J’s pharmaceutical subsidiary, worth approximately $1 billion for 100 million doses of its vaccine. The deal gives the federal government the option to order an additional 200 million doses, according to the announcement.

https://www.cnbc.com/2021/02/04/covid-vaccine-jj-requests-fda-emergency-use-authorization.html