Automakers mandate masks at all U.S. plants but not requiring vaccines

 Detroit's Big Three automakers and the United Auto Workers (UAW) union said on Tuesday they will reinstate requirements to wear masks at all U.S. plants, offices and warehouses beginning on Wednesday, but are not requiring workers to be vaccinated.

The move is in response to the Center for Disease Control and Prevention’s (CDC) change in COVID-19 guidance for masks for fully vaccinated people related to the Delta variant, General Motors Co (GM.N), Ford Motor Co (F.N) and Chrysler parent Stellantis NV (STLA.MI) said in a joint statement with the union.

Toyota Motor Corp (7203.T) said effective Wednesday it will reinstate mask requirements at nearly all U.S. facilities, with the exception of two Michigan facilities that are in counties with moderate transmission rates.

Nissan Motor Co (7201.T) also said Tuesday it was reinstating its mask requirements for all U.S. employees. Volkswagen AG (VOWG_p.DE) said it was requiring masks at U.S. facilities in COVID-19 hot spots, while Daimler AG's (DAIGn.DE) Mercedes-Benz U.S. unit said it had reinstated mask requirements at U.S. plants late last week.

The UAW does not support requiring all workers to be vaccinated for COVID-19 and U.S. automakers have not mandated vaccines. The union and automakers are strongly encouraging workers to get vaccinated.

"We are urging all UAW members and their families to get vaccinated. The science is telling us very clearly that the only way to get back to normal is to reach a heightened level of immunity," UAW President Ray Curry told members in a letter Tuesday. "However, we also know that for some, there are religious and health reasons for not getting vaccinated."

The CDC said last week fully vaccinated people should wear masks indoors in public spaces in places with substantial or high COVID-19 community transmission rates. The CDC said on Monday that almost 80% of U.S. counties are now at those levels.

In June, the U.S. automakers and UAW announced that fully vaccinated workers at their U.S. factories would not have to wear masks on the job beginning on July 12. Numerous automakers operating in the United States had already begun lifting pandemic mask mandates as cases declined.

Other companies as well as federal, state and local governments are putting more pressure on individuals to get vaccinated. New York City on Tuesday said it will require proof of vaccination for people engaged in indoor activities such as dining, working out in a gym, or seeing a show. read more

Meat packer Tyson Foods said it will require workers to get COVID vaccinations, joining companies including Walt Disney Co (DIS.N) and Walmart Inc (WMT.N) in instituting such a requirement for some parts of their workforces. read more

U.S. President Joe Biden has ordered workers at federal agencies to get vaccinated or submit to regular testing.

https://www.reuters.com/business/autos-transportation/us-automakers-reinstate-mask-mandates-all-plants-effective-wednesday-2021-08-03/

Cal. Covid Cases Up 50% Since Thursday As Evidence Mounts Of Rapid Spread Among Kids

 New cases of Covid-19 in California rose about 10% over the weekend, a timeframe that often sees undercounts due to diminished testing on Saturdays and Sundays. The 10,356 new cases reported on Friday rose to a three-day daily average of 11,135 on Monday. (The state has stopped reporting daily cases on weekends and now reports a three-day lump sum on Mondays.)

That 10% rise on Monday followed a 39% one-day rise from Thursday to Friday of last week, making for a total 49-plus percent rise in new cases since just Thursday. More reliable measures of infection spread have also risen dramatically.

On Wednesday, the number infections per 100,000 people in the state stood at 12.7. On Monday, that had risen to 16.7 infections per 100,000, about a 30% rise in five days.

The state’s 7-day test positivity rate — another trusted indicator of spread — was up from 6.2% on Thursday to 6.9% on Monday. That’s an 8% rise. On June 15, the day the state threw off Covid-19 restrictions, the 7-day test positivity rate was .9%.

California hospitals have added over 1,000 new Covid patients in the past week, a substantial increase given that the number of patients hospitalized with the virus last Monday the 26th was 3,595. Today the reported number of infected patients was 4,772.

L.A. is driving much of the surge. On one day last week the county, which accounts for 25% of the state’s population, registered nearly half of its new daily cases.

Providence Saint John’s Health Center in Santa Monica — a city where approximately 80% of eligible residents are vaccinated — is currently packed with Covid patients, according to a Monday New York Times report.

Numbers presented by L.A. County Public Health Director Barbara Ferrer last Tuesday indicate there has been a fivefold increase in new Covid patients under 12 years old. (For perspective those under 12, who are not eligible for vaccination, make up about 15% of the county’s population.) While raw case numbers were low relative to county residents ages 12 to 49, data indicating the spread of infections are not.

In the two-week period ending July 18, there were 89 cases per 100,000 people age 0 to 4 and 112 cases per 100,000 age 5 to 11. While there were no pediatric Covid deaths recorded in the county for the period from June 18 to July 18. Ferrer’s presentation to the board indicated that the hospitalization rate for children age 0 to 4 in Los Angeles County has doubled in a month. See chart below.

LACDPH

The spike in case rates among the very young is precisely what many health experts have feared, as daily vaccinations are still low compared to last winter and the state’s vaccination rate for all citizens — including those not eligible for vaccines — remains below 55%. Many kids in the state are due to be back in school shortly, where masks have been mandated.

The news from one East Bay area school district that recently returned to in person learning is not promising. The 11-school Brentwood district confirmed at least 15 positive Covid cases among its students and staff just three days into the new school year. While cases among kids are most often mild, a more rapid spread due to the Delta variant — and the possibility of new variants popping up as the virus mutates among new hosts — is not a pretty picture for kids or parents, who’ve already been through a year of pandemic worries, not to mention homeschooling.

https://deadline.com/2021/08/california-covid-cases-up-fifty-percent-spread-among-kids-1234807685/

NYC Phases Out Positivity Rate For COVID Decisions—Just As CDC Says It's Useful

 

NYC's positivity rate and the 7-day average of the positivity rate

Starting next week, New York City will no longer use COVID positivity as an indicator of the pandemic’s grip on the five boroughs, the mayor announced. Instead, cases, vaccinations and hospitalizations will guide the city’s policy decisions.

“It’s just not going to be how we strategically make decisions,” Mayor Bill de Blasio said Monday of the data point that judges how many tests come back with an infection.

The pivot comes after the Centers for Disease Control and Prevention issued new mask guidance based in part on positivity rate. The agency now recommends that everyone wear face coverings indoors, regardless of vaccination status, in areas where cases rise above 50 infections per 100,000--or if the positivity rate jumps above 8%.

As of August 2nd, community transmission is prominent enough in all five boroughs and all but one New Jersey county to make universal masking a good idea, according to CDC data.

The mayor and city Health Commissioner Dr. Dave Chokshi cited widespread vaccination and low testing rates as a reason to stop announcing positivity rate, which is calculated by dividing the number of positive tests by the total number of tests taken in a given day. Although genetic testing via PCR declined along with cases between April and early July, the seven-day rate has risen dramatically in recent weeks—from just over 22,000 on July 5th to more than 33,000 on July 30th.

Indeed, daily PCR testing this year hasn’t fallen anywhere near the low points witnessed in spring 2020, when the nation struggled to screen people for infections. And, according to city health department data, enough tests are being done to accurately gauge transmission in more than 83% of New York City neighborhoods.

The number of tests being done does affect the accuracy of the positivity rate data, notes Dr. Denis Nash, an epidemiology professor at the CUNY Graduate School of Public Health. But with testing on the rise and widely available, that alone isn’t a reason to abandon the metric—especially when so many people are unvaccinated.

“The positivity rate is not something I would get rid of,” he said. “I don’t find the rationale that the mayor and other experts gave very compelling.”

That’s because unvaccinated people are more likely to catch the virus and get tested--making positivity an important gauge of how the virus is circulating among those who are least protected.

And it’s better to rely on more metrics, rather than fewer, when trying to assess community transmission. The positivity rate, for example, indicates whether an area is running out of resources to keep track of asymptomatic cases. A different metric--called the effective reproduction number or infection growth rate--would explain how fast the outbreak is building.

“It’s always been problematic to rely on any one indicator,” Nash said. “All of these metrics are imperfect in one way or another. When you look at them all at once, they tend to help you see something close to what the true picture might be.”

The health department will still publish positivity rates on its data page, the mayor and city health commissioner said. Currently, their teams release citywide as well as neighborhood-level numbers.

The positivity reached a rolling average of 3% citywide on July 30th, the highest it’s been since late April. Rates vary widely across the city—from just over 1% in parts of Queens to nearly 8% in the Annadale/Rossville and Charleston/Prince’s Bay/Woodrow neighborhoods of Staten Island.

https://gothamist.com/news/nyc-phases-out-positivity-rate-for-covid-decisionsjust-as-the-cdc-says-its-useful

Half of Florida COVID-19 hospitalizations under 55; 96% unvaccinated

 The number of people hospitalized in Florida because of COVID-19 continued at a record pace Monday, according to the Florida Hospital Association.

The industry group said 10,389 people were hospitalized for COVID-19 -- the second day in a row that the number was over 10,000 and the highest daily total since the start of the pandemic.

During an interview with MSNBC, Mary Mayhew, the president and CEO of the association, called the increase "dramatic" and said the disease is "attacking a younger population and putting them in the hospital." 

Mayhew said 50% of the people hospitalized are between ages 25 and 55. She also said 96% of people hospitalized were unvaccinated.

The surge in hospitalizations has come as the overall number of reported infections has risen dramatically in recent weeks, fueled by the highly transmissible delta variant of the coronavirus.

Florida registered its largest-ever single-day total of new COVID-19 cases -- 21,683 -- on Friday, according to data from the federal Centers for Disease Control and Prevention.

The CDC on Monday did not post new Florida case numbers from the weekend. Florida was one of 32 states with no COVID-19 infection data for Saturday and Sunday. The state Department of Health in early June scaled back to posting data once a week, with its reports coming out on Fridays.

State Agriculture Commissioner Nikki Fried, who is running for the Democratic gubernatorial nomination in 2022, called again Monday for Gov. Ron DeSantis’ administration to return to providing daily reports to the public. Fried said residents were "completely in the dark" about what was going on.

Christina Pushaw, the governor’s press secretary, pushed back against Fried, saying that the state was sending data to the CDC on weekdays. The Florida Department of Health routinely and automatically reports COVID-19 data Monday through Friday, she said.

Department of Health Communications Director Weesam Khoury said the federal government has not required the states to report data on the weekend since June 18.

A review of the data, though, shows that this is the first time the state has not reported the information.

The rise of cases and hospitalizations in Florida also drew the attention of the White House.

White House Press Secretary Jen Psaki, noting that 20% of all new cases in the nation are coming in Florida, said schools should be allowed to enact mask mandates and that vaccinations should be encouraged. DeSantis on Friday issued an executive order barring school districts from requiring students to wear masks.

"So, you know, at a certain point, leaders are going to have to choose whether they're going to follow public health guidelines or whether they're going to follow politics," Psaki said.

DeSantis has disputed the need for children to wear masks and has argued that the decision should be left up to parents. His executive order threatened to withhold funding for school districts that require students to wear masks.

"I have young kids. My wife and I are not going to do the mask thing with the kids," DeSantis said Friday. "We never have. I want to see my kids smiling. I want them having fun."

DeSantis recently has encouraged people to get vaccinated, though he has also blocked businesses from requiring customers to show proof of vaccination --- the concept known as "vaccine passports."

https://www.fox13news.com/news/half-of-florida-covid-19-hospitalizations-under-55-96-unvaccinated

'Erratic' FDA and inconsistent drug decisions put doctors off new meds: survey

 

Specialty physicians are losing faith in the FDA over the past year's surprise delays, inconsistent approvals and rejections.(Spherix Global Insights)

Stunning reversals, surprise delays and controversial approvals are the order of the day at the FDA lately—and doctors have had enough.

Physicians’ trust in the agency is plummeting, according to a recent survey by Spherix Global Insights. More than 40% of the doctors surveyed said their confidence in the FDA has dropped over the past year

Doctors cited a range of problems—including suspected political motivations and lack of transparency—as frustrating pain points in the July survey of 252 specialty nephrologists, neurologists, dermatologists, rheumatologists and gastroenterologists.

“It wasn’t so much the specialists feeling that the FDA was being too aggressive or too lax, but just erratic,” Spherix President Jennifer Robinson said. “In the past, if a company hit all their endpoints and nothing funky came out of the clinical trial—and the trial was designed in conjunction with the FDA—we were pretty much expecting an approval."

Disappointed neurologists and nephrologists are leading the decline, flummoxed by both Biogen Alzheimer’s drug approval despite an expert advisory committee’s decisive no vote and the surprise rejection of Ardelyx’s tenapanor in chronic kidney disease.

Neurologists are particularly discouraged—84% have lost confidence in the FDA over the past year, Spherix found. The controversial approval of Biogen’s Aduhelm in June is the key culprit; 82% of neurologists disagreed with the FDA nod. However, neurologists also questioned the FDA's surprise rejection for Acadia’s Nuplazid to treat hallucinations in dementia-related psychosis.

One neurologist summed up many of the Aduhelm comments in describing the diminished trust in the FDA.

“The erosion is based on the disastrously bad decision to approve aducanumab, which seems like a poorly developed and even possibly corrupt decision," the doctor said. "I cannot remember a similar situation in which there was so much dismay and disbelief created by an FDA decision. We do not plan to use aducanumab at this time and we no longer know what to think about and how much to trust any future FDA decisions."

Another hot topic for specialists is the JAK inhibitor class. Beginning with the FDA's rejection of Gilead’s filgotinib in rheumatoid arthritis last August, JAK inhibitors have been having a tough go. AbbVie’s Rinvoq, Eli Lilly and Incyte’s Olumiant, and Pfizer’s abrocitinib are all sitting in a holding pattern as the FDA scrutinizes Xeljanz’s post-market safety study and holds up new approvals across the whole JAK class.

Rheumatologists and dermatologists agree that it’s OK to scrutinize the class. But the specialists question why the FDA is holding up three JAK meds in atopic dermatitis, plus applications for Rinvoq and Xeljanz in rheumatology, based on a high-risk patient trial for one drug—Xeljanz, Spherix's Lynn Price, VP of strategy and innovation, said.

More than two-thirds of rheumatologists and dermatologists believe the FDA should focus on each individual JAK and its own studies, she said.

Robinson added, “The transparency really rang through with autoimmune specialists, who said, ‘Just tell us why and give us a timeline. When we can expect this and what is the hold-up?’”

The main theme from the Spherix study is the unpredictability of the FDA—and doctors are left wondering why. Some pointed to biases and politics and the possibility that the COVID-19 pandemic is wreaking more havoc inside the FDA than it’s letting on.

Still, no matter the reason, the result is a slower uptake of drugs and a cautious physician population.

So cautious, in fact, doctors told Spherix they plan to go it alone. Many told Spherix they will read and interpret trial data for themselves, wait for medical conferences to hear trial data presented directly by researchers, or simply delay prescribing a new drug until real-world evidence accumulates.  

Analysts are wondering what’s going on as well. Piper Sandler put out a note this week detailing the Spherix data and asking its own questions.

Its number-crunching analysis shows that the FDA's big picture remains relatively stable, with this year's number of rejections and approvals on par with previous years. However, that hasn’t stopped the handful of surprise FDA jabs from knocking the industry for a bit of a loop.

“We think FDA inconsistencies provide a key explanation for the sector's recent underperformance,” Piper said, adding “while the numbers may indicate things are more consistent than perceived, we think perception matters quite a lot here.”

What’s next? That’s likely up to the FDA.

"We've really seen the pendulum go back and forth decision by decision based on feedback that they're getting—Aduhelm has been such a black eye," Robinson said.

As Piper noted, the next high-profile approvals on deck—BioMarin’s delayed vosoritide for children with achondroplasia now set for November and Akebia Therapeutics’ vadadustat in March 2022—are at “higher risk now.”

Its final sentiment: “The next few high-profile regulatory decisions will be critical not just for the investability of biotech, but for nothing less than the preservation of physicians' trust in FDA."

https://www.fiercepharma.com/marketing/erratic-fda-and-inconsistent-drug-decisions-confound-specialty-physicians-changing

Sanofi Translates its mRNA interest into big bucks

 Try before you buy: that seems to be Sanofi’s motto. The French group, which has been working with the mRNA specialist Translate Bio since 2018, finally acquired its partner today for $3.2bn.

A look at Sanofi’s other recent purchases shows this pattern playing out several times. However, unlike some of these deals, buying Translate seems like a no-brainer. The group is relatively cheap compared with many of the other mRNA players, and there is a growing belief that this technology will be the next big thing in vaccines, and not just those for Covid-19.

The deal will make Sanofi the only large vaccine player with a wholly owned mRNA platform in house, Leerink analysts noted, although other big hitters like Pfizer and Glaxosmithkline already have high-profile partners. With Translate now off the scene, Arcturus Therapeutics, with a market cap of around $900m, now looks like the only affordable mRNA player.

mRNA revolution?

Sanofi has no doubt been tempted by mRNA’s potential to revolutionise the vaccine space, partly through the ability to develop and scale up new shots rapidly, as seen during the pandemic.

The coronavirus has helped validate mRNA, but the question now is whether impressive results in Covid-19 will translate across other infectious diseases, and indeed whether mRNA can move into areas such as oncology, which is surely where big money lies.

Following disappointing efficacy with Curevac’s Covid-19 vaccine there are also questions about the unmodified mRNA approach, which Translate also employs. Moderna and Pfizer/Biontech’s jabs use modified mRNA.

Still, Sanofi’s bet looks reasonable. Given the potential advantages of mRNA vaccines over traditional approaches, arguably any vaccine player without mRNA technology risks getting left behind.

Perhaps Sanofi could have pulled the trigger sooner and saved itself some money, particularly as it has been familiar with Translate for so long. The groups’ initial 2018 deal covered five undisclosed infectious diseases; in March 2020 the companies teamed up to develop a Covid-19 vaccine, before expanding their agreement later that year to include all infectious diseases.

After Covid-19, the most immediate focus is flu, where a candidate recently entered phase 1. Leerink analysts have speculated that a respiratory syncytial virus project could also be in the works.

Outside infectious diseases, Translate is developing therapeutics for lung and liver diseases, but there are big question marks about this approach after the group’s inhaled mRNA against cystic fibrosis flunked a phase 1/2 trial. Translate has switched to a next-generation project, but this is still at the preclinical stage.

And if delivering mRNA to the lungs is a dead end, this would wipe out half of Translate’s pipeline.

Covid latecomer

Translate and Sanofi have also been slow in developing their Covid-19 shot despite their early start: the project, called MRT5500, is only just in phase 1/2, with results expected this quarter.

Perhaps being behind the likes of Pfizer/Biontech and Moderna does not matter: the pandemic is not going to last forever, and Sanofi is betting on the long-term promise of mRNA.

It is not the only big pharma to do so. Pfizer talked up its mRNA platform during its earnings call last week, although it is unclear whether future projects will involve its Covid-19 partner, Biontech. Glaxosmithkline has also waxed lyrical about the potential of mRNA, and is working with Curevac on a multivalent Covid-19 vaccine and a flu jab, with further plans to develop a universal flu vaccine.

Moderna and Biontech, too, will make formidable competitors. These are too big to be bought out now, boasting valuations of $139bn and $82bn respectively. Perhaps some larger groups might now be taking a look at Arcturus.

Sanofi's recent acquisitions
Target	Sector	Value	Date announced	Note
Translate Bio	mRNA vaccines & therapeutics	$3.2bn	Aug 2021	Partnered on infectious diseases vaccines since 2018
Tidal Therapeutics	mRNA to reprogramme immune cells	$160m upfront & $310m milestones	Apr 2021
Kymab	Autoimmune diseases	$1.1bn upfront & $350m milestones	Jan 2021
Kiadis Pharma	NK cell therapy	$358m	Nov 2020	Sanofi licensed Kiadis project in Jul 2020
Principia Biopharma	Autoimmune diseases	$3.7bn	Aug 2020	Sanofi licensed Principia project in 2017
Synthorx	Immuno-oncology	$2.5bn	Dec 2019
Source: Evaluate Pharma. https://www.evaluate.com/vantage/articles/news/deals/sanofi-translates-its-mrna-interest-big-bucks

Zymergen Business Update: No 2021 Product Revenue

 Zymergen Inc. (“Zymergen” or the “Company”), today provided a business update regarding its commercial product pipeline and financial forecast.

Zymergen recently became aware of issues with its commercial product pipeline that will impact the Company’s delivery timeline and revenue projections. Accordingly, the Company no longer expects product revenue in 2021, and expects product revenue to be immaterial in 2022.

During the quarter, several key target customers encountered technical issues in implementing Hyaline into their manufacturing processes typical of new product and process development learnings. The Company has made significant progress towards addressing these challenges and believes there are no intrinsic technical issues with Hyaline. However, this issue has resulted in a delay in the Company’s commercial ramp. Zymergen is working to strengthen its commercial team to ensure the reliability and robustness of the sales pipeline qualification and forecast processes.

The Company is also evaluating emerging data on the total addressable market for foldable display applications, which indicate a smaller near-term market opportunity that is growing less rapidly than anticipated, as well as its impact on Zymergen’s sales forecast. The Company will conduct a full re-examination of Zymergen’s target markets confirming our past views or altering them if the data indicate a shift in market focus is appropriate.

https://finance.yahoo.com/news/zymergen-provides-business-200500661.html