Pfizer to cut U.S. sales staff as meetings with healthcare providers move to virtual

 

Pfizer Inc said on Tuesday it is reducing its U.S. sales staff as it expects doctors and other healthcare providers to want fewer face-to-face interactions with sales people after the COVID-19 pandemic ends.

The move comes as the company is expected to announce more than $80 billion in revenue in 2021 on strong sales of the COVID-19 vaccine it developed with Germany's BioNTech SE. That would be record sales for a pharmaceutical company, according to Pfizer Chief Executive Albert Bourla.

"We are evolving into a more focused and innovative biopharma company, and evolving the way we engage with healthcare professionals in an increasingly digital world," the company said in a statement.

"There will be some changes to our workforce to ensure we have the right expertise and resources in place to meet our evolving needs."

The company did not specify how many sales jobs it was cutting.

A source familiar with the matter said Pfizer was eliminating a few hundred positions. The company also plans to create new positions in different areas for around half those jobs, the source said.

According to a document seen by Reuters, Pfizer believes that doctors and other healthcare professionals will want around half of their interactions with drug companies to be remote in the future.

Pfizer's revenue is expected to climb even higher this year and is projected to top $100 billion, according to analyst estimates.

Around half of the company's 2022 sales are expected to come from the COVID-19 vaccine and its new oral COVID-19 treatment, Paxlovid.

The vaccine and Paxlovid are being sold directly to governments in the near-term.

https://www.marketscreener.com/news/latest/Exclusive-Pfizer-to-cut-U-S-sales-staff-as-meetings-with-healthcare-providers-move-to-virtual--37521818/

Biden health officials slammed at hearing for confusing pandemic messaging

 Top Biden administration health officials faced pointed questions during a Senate hearing Tuesday about confusion surrounding pandemic guidance.

Sen. Richard Burr (N.C.), the top Republican on the Senate Health Committee, blasted the administration's difficulties in communicating information on testing, boosters and isolation.

“This administration has time and again squandered its opportunities and made things worse in the decisions you’ve made on testing and treatments and most crucially in communicating with the American people," Burr said during the hearing.

"I’m hoping that you’ll understand that my criticism comes from a place of concern. Because your communication efforts are a mess and have only made things worse," Burr added.

Burr slammed last summer's announcement, and then reversal, that vaccinated people did not have to wear masks indoors.

Burr said the rollout of boosters was a "disaster" and the recent update to the isolation and quarantine period left people confused. 

In late December, the Centers for Disease Control and Prevention (CDC) shortened the time it said people should isolate if infected with COVID-19 or quarantine if exposed. Anthony Fauci, the United States' top infectious diseases doctor, hinted that there would be a testing component added.

But CDC Director Rochelle Walensky did not back away from her initial guidance and said a negative test was not necessary to leave isolation — a person could take a test if they wanted, but should extend isolation if they continue to test positive.    

"I’m not questioning the science," Burr said. "But I’m questioning your communication strategies. It’s no wonder the American people are confused."

Walensky and the CDC have come under fire for failing to adequately communicate agency guidance from people both outside and inside the agency, reflecting rising frustration with the administration's efforts. 

Later in the hearing, Burr expressed frustration at the continued shortage of at-home tests and questioned the administration's ability to procure the 500 million tests President Biden announced in December. 

"Something's not right here, guys, on testing," Burr said, noting that there are currently only contracts signed for 50 million tests. 

"Testing's broken. ... When you guys huddle inside the COVID team, try to get the administration to refrain from making these proclamations until we have the product," he said. 

During the hearing, Walensky said the omicron variant accounted for 98 percent of all sequenced COVID-19 cases in the U.S. in the week ending Jan. 8, up from 95 percent in the previous week.

Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged the challenge and strain from omicron on hospitals and health systems. 

“I think it's hard to process what's actually happening right now, which is: Most people are going to get COVID. All right, and what we need to do is make sure the hospitals can still function, transportation, you know, other essential services are not disrupted while this happens," Woodcock said.

“I think right now, we need to focus on continuity of operations for hospitals and other essential services as this variant sweeps through the population. I don't think that will last a really long time, but I think that's where we are right now. So I don’t think prior approaches reflect what’s going on right now," she added.

https://thehill.com/policy/healthcare/589263-biden-health-officials-slammed-at-hearing-for-confusing-pandemic-messaging

NJ declares state of emergency over omicron

 New Jersey Gov. Phil Murphy (D) declared a state of emergency on Tuesday due to the omicron variant of the coronavirus, which has caused cases to spike around the country.

The governor said the state of emergency will allow local hospitals to access state resources easier as facilities have begun to be overwhelmed.

Murphy said New Jersey was recording 35,000 new coronavirus cases a day with more than 10,000 current hospitalizations. 

“COVID-19 remains a significant threat to our State and we must commit every resource available to beating back the wave caused by the Omicron variant,” he said. 

“While we hope to return to a state of normalcy as soon as possible, the step I am taking today is a commonsense measure that will protect the safety and well-being of all New Jersey residents while allowing state government to respond to the continuing threat that COVID-19 poses to our daily lives,” he added. 

Murphy said the public health declaration allows him to keep the tools needed to keep health care workers and children in schools safe. 

He clarified the declaration does not mean he will start another lockdown, implement “universal mandates or passports” or put any new restrictions on businesses. 

Maryland and Virginia have also both recently declared a state of emergency due to the omicron variant. 

On Tuesday, the U.S. recorded its highest hospitalization rate since the beginning of the pandemic.

https://thehill.com/homenews/state-watch/589257-new-jersey-declares-state-of-emergency-over-omicron-variant

Why US could have higher death rate from omicron than other countries

 

• Eric Topol, professor of molecular medicine at Scripps Research Institute, tweeted a series of data points that compared daily COVID-19 cases and deaths for multiple large nations.
• Topol said the U.S. is likely to experience more cases and deaths than other large, developed countries.
• The Centers for Disease Control and Prevention also warned that current increases in omicron cases are likely to lead to a national surge of new infections that could exceed previous peaks of the pandemic.

One researcher is predicting that the U.S. will experience the highest death rate from the omicron variant than many other developed nations, despite the variant being less severe. 

Eric Topol, a professor of molecular medicine at Scripps Research Institute, tweeted a series of data points that compared the daily COVID-19 case count and deaths per million people for seven large nations. Topol said the U.S. has a much higher baseline of deaths per capita because there was a relative lack of containment during an earlier surge of the delta variant and a lack of vaccinations. 

The Centers for Disease Control and Prevention (CDC) recently warned that current increases in omicron cases are likely to lead to a national surge of new infections that could exceed previous peaks. The agency said its modeling data indicated a large surge of infections could begin in early January 2022, which is in fact being observed in cities across the U.S. 

Last week, the state of Florida experienced an 849 percent increase in COVID-19 cases and before that, New York state reported the highest number of COVID-19 cases in a single day since the pandemic began over a year ago.  

At a national level, the U.S. reported over 1 million COVID-19 cases in a single day on Jan. 4, the highest single day total recorded since the pandemic began.  

The grim numbers out of the U.S. stand in stark contrast to other countries, including South Africa where the omicron variant was first detected. Salim Abdool Karim, South Africa’s top infectious disease scientist, said last month that because more than 70 percent of the country’s population has been previously infected with other COVID-19 variants along with the fact that omicron’s level of severity is low compared to previous variants, South Africa was seeing a sharp decline in omicron cases.  

“In South Africa, variants, even highly mutated ones, will run out of people pretty quickly. Pretty much by the end of last week it was running out of steam; there just aren’t enough people left to infect,” said Karim. 

Data from John Hopkins University and Medicine shows that the U.K. may also be leveling off its peak of COVID-19 cases, showing a steady decline in the number of daily cases over the last week. The U.K. government also says that about 90 percent of people aged 12 and up have received their first dose of a COVID-19 vaccine, and 83 percent have gotten their second dose. About 62 percent of the U.K. population has received their booster shot too. 

The U.S. is behind when it comes to vaccination efforts in comparison to the U.K., with data from the Centers for Disease Control and Prevention (CDC) reporting only about 74 percent of the country having received at least one dose of a COVID-19 vaccine. About 62 percent are fully vaccinated and only 36 percent have gotten their booster dose.  

Scott Gottlieb, former U.S. commissioner of the Food and Drug Administration, also noted that the U.S. vaccination rates aren’t as strong as the U.K. saying in a tweet, “our protracted wrangling over boosters may have sowed confusion, sapping consumer interest.” 

COVID-19 deaths are also by far the worst in the U.S., surpassing all global nations tracked by John Hopkins. Over 800,000 people have died in the U.S. from COVID-19, with Brazil the only country coming close to that amount, recording over 600,00 COVID-19 deaths. 

Some scientists don’t think the coronavirus pandemic will ever be completely eradicated, instead the pandemic will transition into an endemic. That's a state where COVID-19 would continue to circulate, but people would have gained enough immunity to it from vaccinations and natural infection that there would be significantly less transmission. 

https://thehill.com/changing-america/well-being/prevention-cures/589297-why-the-us-could-have-a-higher-death-rate-from

BioNTech, InstaDeep Develop, Successfully Test Early Warning System to Detect Potential High-Risk SARS-CoV-2 Variants

 

• Early Warning System combines Spike protein structural modeling with artificial intelligence (AI) to detect and monitor high-risk SARS-CoV-2 variants, identifying >90% of WHO-designated variants on average two months prior to officially receiving the designation
• Study introduces a new method of combining publicly available SARS-CoV-2 sequence information with predictive analytics to effectively detect and monitor potential high-risk variants which could help increase preparedness against future variants of concern
• Early Warning System is fully scalable as new variant data become available
• Study is available on the pre-print server BioRxiv and has been submitted to a peer-reviewed journal

BioNTech SE (Nasdaq: BNTX, “BioNTech”) and InstaDeep Ltd (“InstaDeep”) today announced the development of a new computational method that analyses worldwide available sequencing data and predicts high-risk variants of SARS-CoV-2. The Early Warning System (EWS) developed in collaboration by BioNTech and InstaDeep is based on artificial intelligence (AI) calculated immune escape and fitness metrics.

The new method combines structural modeling of the viral Spike protein and AI algorithms to quickly flag potential high-risk variants entered into SARS-CoV-2 sequence data repositories within less than a day based on metrics scoring their fitness (e.g. ACE2 and variant Spike protein interaction) as well as their immune escape properties. The companies validated these predictions using experimental data generated in-house and publicly available data.

During the trial period, the system has identified >90% of the World Health Organization (WHO)-designated variants (Variants of Concern, VOC; Variants of Interest, VOI; Variants Under Monitoring,VUM) on average two months in advance. WHO-designated variants Alpha, Beta, Gamma, Theta, Eta and Omicron were detected by the EWS in the same week its sequence was first uploaded. The Omicron variant was ranked as a high-risk variant the same day its sequence became available. The IHU variant observed in France has also been evaluated by the EWS, which highlighted immune escape properties that are relatively similar to Omicron but with significantly lower fitness, making it less of a concern given current data.

The results from the study underline that the EWS is capable of evaluating new variants in minutes and risk monitoring variant lineages nearly in real-time. It is also fully scalable as new variant data becomes available.

https://investors.biontech.de/news-releases/news-release-details/biontech-and-instadeep-developed-and-successfully-tested-early/

Stop Using LuSys Laboratories COVID-19 Tests: FDA

 Date Issued: January 11, 2022

The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false results when using these tests. Neither test has been authorized, cleared, or approved by the FDA for distribution or use in the United States.

The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.

Recommendations for Test Users, Caregivers, and Health Care Personnel

Stop using LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests.

COVID-19 Antigen Test (Nasal/Saliva)

• Test users and caregivers: Talk to your health care provider if you were tested with the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and you have concerns about your test results.
• Health care personnel: If the antigen test was given less than two weeks ago, consider retesting your patients using a different SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
• Report any problems you experience with the LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) to the FDA, including suspected false results. See Reporting Problems with Your Test.

COVID-19 IgG/IgM Antibody Test

• Test users and caregivers: Talk to your health care provider if you were tested with the LuSys COVID-19 IgG/IgM Antibody Test and you have concerns about your test results.
• Health care personnel: Consider retesting your patients using a different SARS-CoV-2 antibody test if you suspect a recent or prior COVID-19 infection.
• Report any problems you experience with the LuSys COVID-19 IgG/IgM Antibody Test to the FDA, including suspected false results. See Reporting Problems with Your Test.

Test Descriptions

The LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) uses a nasal swab or a saliva (spit) sample intended to detect proteins, called antigens, from the SARS-CoV-2 virus.

The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples. The antibody test is intended to look for antibodies produced in response to SARS-CoV-2, the virus that causes COVID-19, by a person’s immune system, indicating a recent or previous infection. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection.

The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics, Vivera Pharmaceuticals, or with the trade name EagleDx. The FDA believes that these tests were distributed for use in laboratories or for at-home testing.

Potential Risk of False Test Results

LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva):

• False-negative antigen test results mean that the test says the person does not have COVID-19 but the person is actually infected. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are grouped into cohorts (that is, they are housed together) in health care, long-term care, and other facilities based on these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
• False-positive antigen test results mean that the test says the person has COVID-19 but they are actually not infected. A false-positive result may lead to a delay in both the correct diagnosis and the initiation of an appropriate treatment for the actual cause of a person’s illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are grouped into cohorts (that is, they are housed together).

LuSys Laboratories COVID-19 IgG/IgM Antibody Test:

• False-negative antibody test results mean that the test says the person does not have antibodies to the SARS-CoV-2 virus when the person actually does have antibodies. False-negative results could lead test users to take fewer precautions to prevent spread of infection if the test is used inappropriately to diagnose active infection or if the test result is interpreted to mean that they did not have a recent infection.
• False-positive antibody test results mean that the test says the person does have antibodies to the SARS-CoV-2 virus, when the person actually does not have antibodies to the SARS-CoV-2 virus. False-positive results could lead test users to take fewer precautions to protect themselves from a future SARS-CoV-2 infection if the test result is interpreted to mean that they have had a previous SARS-CoV-2 infection.

FDA Actions

The FDA regularly monitors the marketing of unauthorized, unapproved, or uncleared tests, including reports of problems with test performance or results. The FDA is providing this information to help educate test users, caregivers, health care personnel, and the public and to reduce the risk of false test results that could lead to serious illness and death.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Test

If you think you had a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

If you think you had a problem with your device, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

If you have questions about this Safety Communication, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

https://www.fda.gov/medical-devices/safety-communications/stop-using-lusys-laboratories-covid-19-tests-fda-safety-communication

D.C. To Distribute Rapid COVID-19 Tests To Pre-K Students Every Week

 D.C. will begin distributing rapid COVID-19 tests to pre-K and kindergarten children at public and charter schools every Friday while cases remain high, though it remains to be decided whether those students will be required to return a negative test every Monday in order to attend classes. Mayor Muriel Bowser has not specified a timeline or a case threshold for providing the tests.

Speaking Monday morning, Bowser said the decision reflected the reality that most kids in the city’s pre-K program are not old enough to be vaccinated, and even some entering kindergarten may not be either. There are roughly 13,000 kids in pre-K programs in D.C. Public Schools and charter schools.

“Our pre-K kids are unvaccinated. We are targeting them with weekly tests,” she said.

Dr. Christina Grant, the state superintendent of education, said the decision to offer rapid tests grew from concerns raised by some schools and parents that saliva-based testing options were too complicated for young children.

School staff will also be provided with rapid test kits.

Last week DCPS coordinated a massive rapid-testing campaign of more than 49,000 students and staff ahead of a return to in-person classes on Thursday. (A snow day closed schools on Friday.) Bowser said DCPS will extend its “test to return” program of testing all students and staff after the scheduled February winter break and April spring break.

She also said that DCPS would continue with symptomatic testing and pursue the target of randomly testing 20% of asymptomatic students, with the ability to scale up to 30% “when case rates are high.” Most charter schools run their own testing regimes, some of which are more stringent and require weekly testing of all students and staff.

Bowser and Grant also said they would soon launch a “Test to Stay” policy for D.C. schools, under which unvaccinated students who are close contacts of someone who tests positive for COVID-19 can remain in school as long as they regularly take rapid tests that come back negative. The model, which has been tested in Montgomery County and promoted by the Centers for Disease Control and Prevention, is seen as a means to help parents manage COVID exposures in schools and the usual quarantines and missed school days that would follow.

Despite these new initiatives, Grant urged parents to get all eligible children vaccinated. According to D.C. data, just under 20% of kids aged 5 to 11 have gotten either a single dose or both doses of the COVID-19 vaccine. Among kids aged 12-15 it’s 68%, and 65% for kids aged 16 and 17.

“I want to be crystal clear that it is critically important for families and students who have access to the vaccine to take the vaccine. That is the critical way to ensure children can remain in schools,” said Grant.

Bowser also announced an expansion of the popular distribution of rapid testing kits, saying that six senior wellness centers would start giving out the at-home tests to people aged 65 and above. The remaining distribution sites for D.C. residents can be found here.

https://dcist.com/story/22/01/10/dc-will-give-rapid-covid-tests-to-prek-kids/