Tuesday, November 2, 2021
Will Valneva , Dynavax Score With Late-to-the-Party COVID Vaccine?
- Valneva's phase 3 data for its COVID-19 vaccine compared well against AstraZeneca's vaccine.
- Dynavax is set to profit from sales of its adjuvant used in Valneva's vaccine.
Valneva (NASDAQ:VALN) recently reported positive results from a late-stage study of COVID-19 vaccine VLA2001. The vaccine uses Dynavax's (NASDAQ:DVAX) Cpg 1018 adjuvant. In this Motley Fool Live video recorded on Oct. 20, 2021, Motley Fool contributors Keith Speights and Brian Orelli discuss the potential for commercial success of this late-to-the-party vaccine.
Keith Speights: Let's switch to some other COVID-19 news from earlier this week. Valneva, ticker there is VALN, reported positive results from a Phase III study of its COVID-19 vaccine candidate, VLA2001. This vaccine uses the CpG 1018 adjuvant developed by Dynavax.
Brian, what do you make up of these results, and do you think Valneva and Dynavax could achieve significant commercial success with this vaccine, which is late to the party?
Brian Orelli: We talked about this vaccine, I think, a few weeks ago when the UK government pulled out of a supply agreement with Valneva. The Phase III data that was just released looked pretty good.
The study was comparing VLA2001 which is an inactivated virus to AstraZeneca's (NASDAQ:AZN) vaccine. VLA2001 produced higher antibody levels than AstraZeneca's vaccine, and the tolerability was better, at least in patients that were 30 years and older. Cases of COVID were similar between the two vaccines.
There were no severe disease in either group. That basically says that it's non-inferior on the ability to prevent COVID. Non-inferiority to an already approved drug is pretty standard for infectious diseases. If you have a new antibiotic, you can't compare it to placebo because you can not give patients antibiotic to deal with their infection. You've got to give them control, so you give them the current standard of care, and then you compare your drug to the current standard of care. If it works better, then that's great, and if it works the same well, the FDA's OK with approving it.
Are we at the point during the pandemic where regulators are OK with non-inferiority to a current standard of care? Maybe it seems reasonable to me, but I'm obviously not a regulator. We'll have to wait and see what the regulators think, but I think AstraZeneca should produce solid data, and so I think that comparing it to AstraZeneca's data seems reasonable to me.
The fact that it's producing better antibodies or higher levels of antibodies seems like a good thing and the fact that it's just as good for COVID cases seems reasonable. I think there's definitely a market, especially in the developing world. But as we've talked about previously, that's going to come with lower margins.
We'll have to wait and see how much Valneva can make off of this vaccine. In terms of Dynavax, Dynavax actually just sells the adjuvant to Valneva, so I think it'll make money no matter what the margins are that Valneva is making, although maybe if Valneva is not making as much, they try to squeeze Dynavax a little bit to try to get a lower price on the adjuvants and maybe that hurts Dynavax slightly.
https://www.fool.com/investing/2021/10/29/will-valneva-and-dynavax-score-with-their-late-to/
Should Ocugen Be Soaring Yet?
- A World Health Organization group meets on Wednesday to review Emergency Use Listing for Covaxin.
- Ocugen's shares are likely to jump with this meeting due to investors' excitement and heavy short interest.
- Ocugen has U.S. and Canadian rights to the COVID-19 vaccine, but EUL won't help in those markets.
Moderna's shares have more than tripled in value so far this year. BioNTech has been an even bigger winner for investors. Buying and holding the stocks of leading COVID-19 vaccine makers has turned out to be a pretty good strategy.
But there's one vaccine stock that has outperformed them all in 2021. Shares of Ocugen (NASDAQ:OCGN) have skyrocketed close to 550% year to date. Here's why the stock will probably soar even more tomorrow -- but shouldn't.
Tomorrow -- Nov. 3, 2021 -- a World Health Organization (WHO) technical advisory group is scheduled to meet to review the data for COVID-19 vaccine Covaxin for a potential Emergency Use Listing (EUL). Bharat Biotech, the developer of Covaxin, first officially indicated its interest in receiving EUL for the vaccine back in April 2021.
The technical advisory group has already met previously about Covaxin. However, the group requested some clarifications from Bharat. But the meeting on Wednesday of this week will be a final assessment of the vaccine's qualifications in receiving EUL.
There's no way to know for sure in advance what the technical advisory group's recommendation will be. The smart money, though, is on Covaxin winning EUL.
Covaxin has already won Emergency Use Authorization (EUA) in India, where Bharat is based. Obtaining EUL would clear the way for the vaccine to be distributed to nearly 200 countries that participate in the COVAX Facility, which aims to make COVID-19 vaccines available across the world.
Ocugen shares skyrocketed more than 20% on the day of the first WHO technical advisory group meeting. There's no reason to doubt that history will repeat itself this week. However, there's also no good reason for the stock to jump.
The fact of the matter is that EUL for Covaxin doesn't immediately benefit Ocugen. Sure, the company has marketing rights to the vaccine in the U.S. and Canada. Neither of those countries will receive vaccines as part of the COVAX Facility, though. They're both donors to the initiative.
So why might Ocugen's shares soar tomorrow anyway? It's important to understand the intense interest in the stock among online investing communities. At the same time, the stock has attracted plenty of short-sellers. As of Oct. 15, 2021, close to 29.5% of Ocugen's stock float was sold short.
Because of these two factors, any perceived good news for Ocugen is likely to light a fire beneath its stock. That can happen even when the good news doesn't directly help the company, as is the case with potential EUL for Covaxin.
What really matters the most for Ocugen right now is winning authorization for Covaxin in Canada. The company has completed its submission to Health Canada and awaits a decision.
The second most important thing that matters for Ocugen is moving forward with a pivotal phase 3 study of Covaxin in the U.S. Ocugen announced last week that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin this study.
However, the FDA must first give a green light for the phase 3 study. Ocugen plans to only enroll several hundred participants who have either not been vaccinated or who have received two doses of a messenger RNA vaccine at least six months earlier.
This study would be far smaller than the pivotal studies of other COVID-19 vaccines that have been authorized or approved in the U.S. Ocugen hopes that the FDA will agree that the relatively small study will be sufficient to demonstrate similarity with results obtained in a larger study conducted in India with 25,798 participants.
If the FDA allows Ocugen's study to move forward, it would provide a good reason for investors to get excited. The company thinks that it could wrap up the study in the first half of 2022. That could set the stage for Ocugen to file for full FDA approval of Covaxin shortly afterward.
https://www.fool.com/investing/2021/11/02/why-ocugen-stock-will-probably-soar-tomorrow-but-s/
China won’t give up on its zero-tolerance COVID policy soon
China will not give up on its zero-tolerance policy towards local COVID-19 cases any time soon, some experts said, as the policy has allowed it to quickly quell local outbreaks, while the virus continues to spread outside its borders.
To stop local cases from turning into wider outbreaks, China has developed and continually refined its COVID-fighting arsenal — including mass testing, targeted lockdowns and travel restrictions – even when those anti-COVID measures occasionally disrupted local economies.
“The policy (in China) will remain for a long time,” Zhong Nanshan, a respiratory disease expert who helped formulate China’s COVID strategy in early 2020, told state media.
“How long it will last depends on the virus-control situation worldwide.”
In a major outbreak in July-August, China counted a total of over 1,200 local symptomatic infections. In the latest flare-up, mostly in northern China, some 538 local cases were reported between Oct. 17 and Nov. 1.
Despite the lower caseload, the geographical spread of the infections has put constraints on China’s leisure and tourism sectors.
Since Oct. 23, travel agencies have not been allowed to organise tourism between certain provinces, with such restrictions affecting trips to nearly one-third of the mainland’s 31 province-level regions including Beijing.
Many cities with infections have also closed indoor entertainment and cultural venues. A flurry of marathons, theatrical performances and concerts have been delayed or cancelled.
China also requires weeks of quarantine for most travellers arriving from abroad.
In contrast, some Asia-Pacific countries are starting to open selectively to fully vaccinated international travellers as they seek to secure a more normal footing for their economies and societies.
ANOTHER YEAR?
The successful containment of clusters and popular support for restricting international travel make it overwhelmingly likely that China will stick to its zero tolerance towards domestic cases for at least another year, Gavekal Dragonomics analyst Ernan Cui said in a note.
“Officials seem to believe that giving up on the zero-tolerance approach would just replace one set of problems with another,” wrote Cui.
Respiratory disease expert Zhong told state media CGTN that the current 2% death rate of the disease globally, despite vaccination, is not tolerable in China.
“Zero tolerance costs a lot indeed, but letting the virus spread costs more,” Zhong said.
Some countries had loosened curbs while still reporting some small clusters, leading to a new series of infections that have since forced them to backpedal again, Zhong said.
Such back-and-forth in policy costs more, and has a greater impact on the public, he warned.
The cost of treating COVID patients – on average 20,000 yuan each and sometimes over 1 million yuan for those critically ill – totalled 2.8 billion yuan ($438 million) as of end-June, all paid by the government, state television said in August.
https://kfgo.com/2021/11/02/china-wont-give-up-on-its-zero-tolerance-covid-policy-soon-experts/
COVID-19 still rages, but some U.S. states reject federal funds to help
As the resurgent COVID-19 pandemic burns through the rural U.S. state of Idaho, health officials say they don’t have enough tests to track the disease’s spread or sufficient medical workers to help the sick.
It’s not for want of funding.
The state’s Republican-led legislature this year voted down $40 million in federal aid available for COVID-19 testing in schools. Another $1.8 billion in pandemic-related federal assistance is sitting idle in the state treasury, waiting for lawmakers to deploy it.
Some Idaho legislators have accused Washington of overreach and reckless spending. Others see testing as disruptive and unnecessary, particularly in schools, since relatively few children have died from the disease.
"If you want your kids in school, you can't be testing," said state Representative Ben Adams, a Republican who represents Nampa, a city of about 100,000 people in southwestern Idaho.
Meanwhile, the state is reporting the fifth-highest infection rate in the United States, at 369 confirmed cases per 100,000 people, according to the U.S. Centers for Disease Control and Prevention.
Schools in at least 14 of Idaho's 115 districts, including Nampa, have had to close temporarily due to COVID-19 outbreaks since the start of the year, according to Burbio, a digital platform that tracks U.S. school activity.
Idaho's experience illustrates how political ideology and polarization around the COVID-19 epidemic have played a role in the decision of mostly conservative states to reject some federal funding meant to help locals officials battle the virus and its economic fallout.
For example, Idaho was one of 26 Republican-led states that ended enhanced federally funded unemployment benefits before they were due to expire in September. Gov. Brad Little claimed that money was discouraging the jobless from returning to work. At least six studies have found that the extra benefits have had little to no impact on the U.S. labor market.
Idaho has also rebuffed $6 million for early-childhood education, as some Republicans in the state said mothers should be the primary caretakers of their children.
The state also did not apply for $6 million that would have bolstered two safety-net programs that aid mothers of young children and working families. Little's administration said it had enough money already for those programs.
Idaho has accepted some federal COVID-19 help. In fact, the rejected funds are just a small portion of the nearly $2 billion in federal relief Idaho has spent since March 2020 to fight the virus and shore up businesses and families, state figures show.
But hundreds of millions more remain untouched. Idaho has deployed just $780 million, or 30%, of the $2.6 billion it received under the federal American Rescue Plan Act, signed into law in March.
Neighboring Washington state, by contrast, has parceled out nearly three-quarters of the $7.8 billion it received under that legislation. Washington has recorded roughly 60% as many cases per capita as Idaho since the start of the pandemic, according to the U.S. Centers for Disease Control and Prevention.
Some in Idaho are exasperated that a state of just 1.8 million people would turn down a dime of assistance when it’s struggling to tame the pandemic.
With no testing in place, nurses in Nampa schools rely mainly on parents to let them know when a child is infected, the district's top nurse, Rebekah Burley, told the school board in September. She said she needed three or four more staffers to track existing cases and attempt to keep people quarantined.
"We're tired, we are stressed, and something needs to change," she said.
REJECTING FEDERAL MONEY
The refusal by red states to accept some types of federal aid that would benefit their constituents isn't new.
For example, a dozen Republican-controlled states have rejected billions of dollars available through the landmark 2010 Affordable Health Care Act to cover more people under the Medicaid health program for the poor, which is jointly funded by the federal government and the states. Lawmakers from these places contended their states couldn’t afford to pay their share of an expansion. (Idaho initially was among them, but its voters opted in to the Medicaid expansion through a 2018 ballot referendum, bypassing state leaders.)
That same dynamic has played out during the coronavirus crisis. Since March 2020, Congress has approved six aid packages totaling $4.7 trillion under Republican and Democratic administrations, including the bipartisan CARES Act in March 2020 and the Democratic-backed American Rescue Plan Act this year.
Florida and Mississippi didn't apply for benefits that would give more money to low-income mothers of young children. Four states, including Idaho, North Dakota and Oklahoma, opted not to extend a program that provided grocery money to low-income families with school-age kids in summer months.
Iowa, like Idaho, turned down federal money for COVID-19 testing in schools. New Hampshire rejected money for vaccinations.
Republican lawmakers in Idaho, like those elsewhere, cite concerns about local control, restrictive terms attached to some of the aid, and the skyrocketing national debt.
"We are chaining future generations to a lifetime of financial slavery," said Adams, the Idaho legislator.
Yet even before the pandemic, Idaho long relied on Washington for much of its budget. Federal funds account for 36% of state spending in Idaho, according to the National Association of State Budget Officers, above the national average of 32%.
State officials say they have enough money to handle the COVID-19 crisis for now.
Critics say Idaho's reluctance to use more federal aid is a symptom of its hands-off approach to COVID-19 safety. Few public schools require masks, and local leaders have refused to impose mask mandates, limits on indoor gatherings and other steps to contain the virus.
"There's a lot of people in our legislature and some local officials who really have not taken this seriously," said David Pate, the former head of St. Luke's Health System, the state's largest hospital network.
Idaho has one of the lowest vaccination rates in the nation, with only 55% of adults and teens fully immunized, compared to 67% nationally.
HOSPITALS FULL
COVID-19 is pummeling Idaho even as cases have plunged in much of the nation. Intensive-care units statewide are full, forcing hospitals to turn away non-COVID patients. At least 627 residents died of the disease in October, well above the previous monthly death toll of last winter, records show.
Idaho received $18 million through the American Rescue Plan to hire more public-health workers, but lawmakers did nothing with that money this year.
Some local public health departments say they do not have enough staff to track the virus. "We have a lot of people doing two or three jobs right now," said Brianna Bodily, a spokesperson for the public-health agency serving Twin Falls, a southern Idaho city of 50,000. The department is working with a 12% smaller budget than last year.
Such staff shortages have contributed to a backlog of test results statewide, which the Idaho Department of Health and Welfare says is hurting its ability to provide an up-to-date picture of the disease's prevalence.
With funding bottled up in the state capitol, Little, the governor, announced in August that he would steer $30 million from a previous round of COVID-19 aid to school testing.
The Nampa school district has requested some of that money but has yet to set up a testing program, spokeswoman Kathleen Tucker said. Roughly 80% of the district's students were not attending class regularly in the first weeks of the school year due to outbreaks, according to superintendent Paula Kellerer.
Nampa resident Jaci Johnson, a mother of two children, ages 10 and 13, said she and other parents have been torn over whether to send their children to class, due to the potential risk.
"Do we feed our kids to the lions, or do we keep them home and make them miserable?" Johnson said.
U.S. worker rebellion swells over vaccine mandates
In Wichita, Kansas, nearly half of the roughly 10,000 employees at aircraft companies Textron Inc and Spirit AeroSystems remain unvaccinated against COVID-19, risking their jobs in defiance of a federal mandate, according to a union official.
"We're going to lose a lot of employees over this," said Cornell Adams, head of the local Machinists union district. Many workers did not object to the vaccines as such, he said, but were staunchly opposed to what they see as government meddling in personal health decisions.
The union district has hired a Texas-based lawyer to assist employees and prepare potential lawsuits against the companies should requests for medical or religious exemptions to vaccination be denied.
A life-long Democrat, Adams said he would no longer vote for the party. "They'll never get another vote from me and I'm telling the workers here the same thing."
The clock is ticking for companies that want to continue gaining federal contracts under an executive order by Democratic President Joe Biden, which requires all contractor employees be fully vaccinated against COVID-19 by Dec. 8.
That means federal contract workers need to have received their last COVID-19 shot at least two weeks before the deadline to gain maximum protection, according to U.S. government guidance.
With a three-week gap between shots of the Pfizer /BioNTech vaccine, workers must get the first jab by Wednesday. If the government holds fast to its deadline, it is already too late to choose Moderna's vaccine, which is given in two doses four weeks apart. Workers could opt to get Johnson & Johnson's single-shot vaccine until Nov. 24 to meet the deadline.
The mandate has stirred protests from workers in industries across the country, as well as from Republican state officials.
Opposition to the mandate could potentially lead to thousands of U.S. workers losing their jobs and imperil an already sluggish economic recovery, union leaders, workers and company executives said.
More legal clashes are likely over how companies decide requests for vaccination exemptions.
For the companies, time is getting tight, though the Biden administration has signaled federal contractors will not have to immediately lay off unvaccinated workers who miss the Dec. 8 deadline.
Under government guidance https://www.saferfederalworkforce.gov/faq/contractors published on Monday, companies will have flexibility over how to implement the mandate, which may allow them to avoid mass firings.
"A covered contractor should determine the appropriate means of enforcement with respect to its employee," the guidance said.
For Boeing Co in the United States, more than 7,000 workers have applied for religious exemptions and around 1,000 are seeking medical exemptions, people familiar with the matter told Reuters. That amounts to some 6% of the planemaker's roughly 125,000 U.S employees.
'ILLEGAL, IMMORAL AND IMPRACTICAL'
At a rally last week outside Boeing property in Auburn, south of Seattle, many of the three dozen workers gathered in driving rain said they would rather be escorted off Boeing property on Dec. 8 than take a vaccine. Others said they would pursue early retirement.
"The mandate is illegal, immoral and impractical," said one veteran Boeing program analyst who attended the rally. "We are standing together against a company and government trampling on our rights."
Many legal experts have said vaccine mandates in the interest of public health are legal.
The rebellion has put Boeing executives in a bind. The company could lose skilled staff, but must comply with a presidential order.
A Boeing spokesperson said the company was committed to maintaining a safe working environment for its employees.
The order's provision for religious and medical exemptions is causing more tension.
Two Textron workers who requested religious exemptions told Reuters the company's human resources representatives quizzed them on the name of their church leaders and asked detailed questions about their faith.
Textron declined to respond to questions, but in a statement said it was obligated to comply with Biden's order and was taking steps to do so.
"Employees who are unable to receive the COVID-19 vaccination due to a medical condition or sincerely held religious belief are being provided an opportunity to request an accommodation from this requirement," Textron said.
Spirit AeroSystems did not respond to a request for comment.
Raytheon Technologies' CEO Greg Hayes last week warned the U.S. defense firm will lose "several thousand" employees because of the mandate.
A group representing FedEx Corp, United Parcel Service Inc and other cargo carriers said it would be virtually impossible to have all their workforces vaccinated by the deadline.
Some companies have imposed vaccine mandates even absent immediate government regulation.
Mercedes-Benz USA, the U.S. unit of German carmaker Daimler AG which is not a U.S. government contractor, told employees in an October email seen by Reuters that proof of vaccination against COVID-19 would become a condition of employment beginning Jan. 4.
The carmaker said it implemented the move in anticipation of a separate U.S. government vaccine mandate that would apply to businesses with at least 100 employees, affecting some 80 million workers nationwide.
Less than half of the company's workers at U.S. import processing centers are vaccinated and many refuse to get a shot, according to a source familiar with the matter.
Mercedes USA in a statement said it had given employees 90-day notice to fulfill the requirement, adding that two thirds of its U.S. employees - not including factory workers in Alabama - have provided proof of vaccination to date.
"We expect that the vast majority of our employees will provide proof of vaccination before the deadline," the company said.
BioNTech to Present New Clinical Data from First-in-Class CAR-T Program
BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, today announced that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company's novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation. The presentation is scheduled for the late-breaking abstract poster session at the 36(th) Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held both in person and virtually from November 10 - 14, 2021.
"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."
BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company's clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial
For more information, please visit https://www.globenewswire.com/Tracker?data=mPha8Ludm7WWUzo93omVJFw3-C9oJIc9SAjfIcyUdW_6LKSt2XqWNUoQOOPN0siuoAhkKZX9NM2plQLRW19Drw== www.BioNTech.de