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Friday, January 14, 2022

Omicron-specific vaccine is coming but ‘may not matter—everybody’s going to be infected,’

 An omicron-specific Covid vaccine will be ready by March but some experts warn it could be “too late” due to the variant’s highly transmissible nature.

On Monday, Pfizer CEO Albert Bourla told CNBC that its vaccine with BioNTech that targets omicron — and other variants that are currently circulating — will be ready for distribution by spring and that the company has already started manufacturing doses.

But an omicron-targeted vaccine was needed in Decembersays Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. “It still could be valuable but I do think in many ways, it’s too late” for the current omicron wave, Moss says.

Dr. Shaun Truelove, an infectious disease epidemiologist at Johns Hopkins Bloomberg School of Public Health, agrees: “Given how quickly this [variant] is happening, [the targeted vaccine] may not matter because everybody’s going to be infected,” says Truelove, a member of The Covid Scenario Modeling Hub, a team of researchers who make Covid projections.

The country has been seeing record Covid infections: More than 95% of reported Covid cases were due to the omicron variant as of early January, according to the CDC. On Sunday, over 307,000 new cases of Covid were reported, according to Johns Hopkins.

If an omicron-targeted vaccine had been available earlier, it “might have been sufficient to prevent some of these illnesses and better protect our workforce, particularly health care workers,” says Moss. “The assumption is that an omicron-specific booster would have high vaccine effectiveness against infection, at least temporarily, but this is not known.”

But the variant spread so quickly that vaccine developers could not make a targeted vaccine in time.

Pfizer CEO Bourla also said it is still not clear whether or not the new vaccine is needed or how it could be used.

But given both Covid’s and omicron’s unpredictability, and with new variants likely to emerge, having a vaccine that targets omicron and other variants could be useful in some way, at some point, experts say. “In short, I think there will be some value to those who remained uninfected, assuming omicron continues to be the dominant variant, but the impact of an omicron-specific vaccine will be much less than if it were available earlier before the [surge] in infections,” Moss says.

Truelove agrees, and adds that we don’t know long long omicron infection-induced immunity will last, and an omicron-specific booster could provide “substantial benefit” if immunity wanes, potentially even against future variants.

“But it’s not really possible to know what those impacts will be as of now,” he says.

Moderna CEO Stephane Bancel told CNBC on Monday that it is also working on an omicron-specific booster, which will likely enter clinical trials soon.

Bancel also said on Thursday that a fourth Covid shot may be needed in the fall as the efficacy of boosters will likely decline over time.

Dr. Mark Sawyer, an infectious disease specialist at Rady Children’s Hospital, who served on the FDA advisory committee that approved Covid vaccines in 2020, says while it’s too early to predict if or when a fourth vaccine shot is needed, the fall is plausible.

″[R]espiratory illness is more common in the winter, so boosting people in the fall makes sense,” Sawyer says.

Israel has already given out more than 250,000 fourth doses since early January to Israelis aged 60 and over, medical workers and those who are immunosuppressed, according to The Times of Israel. Early data from Israel shows that a fourth dose does increase antibody levels, says Dr. David Hirschwerk, infectious disease specialist and medical director at Northwell Health’s North Shore University Hospital.

And fourth doses of Covid vaccines for some individuals in the U.S. who are moderately to severely immunocompromised could roll out starting this week, according to The New York Times. The CDC approved a fourth dose for that group in October.

But to what extent that will be recommended to the general public down the road, it’s still too early to say. “I still think we need to have a more complete understanding of what our impact has been from people receiving a third dose,” Hirschwerk says.

One thing that has become clear is that two doses aren’t enough protection against omicron. “There is good evidence that the third dose is providing a lot more protection against omicron,” Truelove says. Bourla also said Monday that two shots do not provide robust protection against infection with that variant.

As of Monday, roughly 63% of the U.S. population is fully vaccinated, according to the Centers for Disease Control and Prevention. Only 36% of those people have received a booster dose.

https://www.cnbc.com/2022/01/10/omicron-vaccine-coming-in-march-experts-warn-it-could-be-too-late.html

Oscar Health Plan of California Notice of Data Breach

 Oscar Health Plan of California recently discovered an incident involving the personal information of a subset of our Members. On or about 11/23/2021, Oscar discovered that a mailing intended for some of our Members from Oscar may have been misrouted to another Oscar Member in error due to a vendor printing issue. We believe this incident occurred between 10/28/2021 and 11/16/2021.

Some of the following information may have been viewed by another Oscar Member as a result of the mismailed information: name, Oscar ID number, claim number, provider information, date of service(s), procedure/service name and plan name/affiliation. This information did not include Social Security number, driver’s license number or any financial account information.

We began an investigation immediately upon discovery of the printing issue and have taken steps to address the matter with our print vendor. While we do not believe there has been a misuse of any personal information, we are notifying our affected members out of an abundance of caution. All mailings that may have been impacted by this incident have been re-sent accordingly. Additionally, we have sent individual notices to those Members whose personal information was impacted by the event.

Oscar is committed to protecting our members’ personal information and we take our responsibility very seriously. If members have any questions or would like to confirm whether they were impacted by this incident, they should contact Oscar immediately at 855-672-2755.

https://finance.yahoo.com/news/oscar-health-plan-california-notice-152600692.html

Axsome Therapeutics's (AXSM) AXS-05 Probability of Success Lowered Following Mgmt Chat

 PT Shashed to $90 - Truist Securities

Analyst Joon Lee lowered the price target on Axsome Therapeutics (NASDAQ: AXSM) to $90.00 (from $160.00)

https://www.streetinsider.com/Analyst+Comments/Axsome+Therapeuticss+%28AXSM%29+AXS-05+Probability+of+Success+Lowered%2C+Following+Mgmt+Chat%2C+PT+Shashed+to+%2490+-+Truist+Securities/19461737.html

Omicron Wave Of COVID-19 Has Peaked In UK: Study

 by Alexander Zhang via The Epoch Times,

The Omicron wave of COVID-19 has peaked in the UK and cases are starting to decrease in all age groups and in almost all regions in the country, a British scientist said on Jan. 13.

Tim Spector, professor of genetic epidemiology at King’s College London and the lead scientist on the ZOE COVID Study app, said data suggests the Omicron wave has peaked, with hospitalisation, deaths, and early data on the severity of the Omicron variant all “looking positive.”

He said COVID-19 symptoms are now “for the first time this winter more common than colds and flu and are indistinguishable.”

According to data from the ZOE COVID Study, 52.5 percent of people experiencing new cold-like symptoms are likely to have symptomatic COVID-19, an increase from last week’s 51.3 percent.

According to ZOE data, there are currently 183,364 new daily symptomatic cases of COVID-19 in the UK on average, a clear decrease of 12 percent from 208,471 reported last week.

Among people who have received at least two vaccine doses, there are currently 83,699 new daily symptomatic cases, a decrease of 11 percent from 93,540 new daily cases reported last week.

The study found that cases are dropping in all regions apart from the northeast, but even there the increase is already slowing and should start dropping soon.

New daily symptomatic cases are also going down in all age groups, with cases among the over-75s plateauing at low levels.

Spector said this is a “reassuring sign” that the more vulnerable group has been spared from the worst of the Omicron wave.

He said he does not expect these rates to go down to zero, but he thinks Omicron “will probably continue to circulate at manageable levels in the population until late spring.”

Some scientists are already predicting COVID-19 will soon become endemic.

Professor David Heymann, from the London School of Hygiene and Tropical Medicine, said on Jan. 11 that the UK has a high level of population immunity and is probably “the closest to any country of being out of the pandemic if it isn’t already out of the pandemic and having the disease as endemic.”

Clive Dix, former chairman of Britain’s vaccine taskforce, said over the weekend that mass vaccination against COVID-19 should come to an end and the UK should focus on managing it as an endemic disease like flu.

Paul Hunter, professor in medicine at the University of East Anglia, also said on Dec. 28 that COVID-19 will become “just another cause of the common cold.”

https://www.zerohedge.com/covid-19/omicron-wave-covid-19-has-peaked-uk-study

Fauci says it is not clear yet if people will need yearly boosters


President Biden’s chief medical adviser Anthony Fauci said in an interview that it is not clear yet if people will need yearly COVID-19 boosters, even as the chief executives of several drugmakers have indicated a fourth vaccine dose may be necessary.

"We've only recently boosted people. We will find out if the booster gives you a degree of durability of protection and actually should be the standard regimen of three doses of an mRNA and two doses of J&J," Fauci said in an interview with NBC News published on Thursday. 

"Or — and it's a big 'or' right now — will we need to boost people every year or so?" he continued.

Fauci said that he while it was a good thing that the original ancestral strain of COVID-19 was used in the development of the COVID-19 vaccine — because “we were fortunate that even though [strains] were different, they were not so different that the vaccine didn't cover it well" — omicron has muddled the situation.

"We were doing quite well with a primary vaccination and a boost with delta. Then all of a sudden omicron came along," Fauci told the network. "And if you look at the efficacy against the delta versus omicron, it went down to around 30 percent."

The leading infectious diseases expert said that he wants a vaccine that would ideally be effective against all kinds of COVID-19 variants.

Fauci’s remarks come as chief executives from drugmakers like Pfizer and Moderna have suggested that people may need a fourth dose of the COVID-19 vaccine amid concerns about the omicron variant and waning booster efficacy.

"I think we will need the fourth dose," Pfizer CEO Albert Bourla told CNBC last month.

"With omicron, we need to wait and see because we have very little information. We may need it faster," than a previous timeline of 12 months, which Bourla had considered to have a fourth dose administered after an individual’s initial booster, the CEO said.

https://thehill.com/policy/healthcare/589707-fauci-says-it-is-not-clear-yet-if-people-will-need-yearly-boosters

Dr. Oz calls Fauci a 'petty tyrant,' challenges him to debate

 GOP Pennsylvania Senate candidate Mehmet Oz, more commonly known as "Dr. Oz" from his TV program "The Dr. Oz Show," called infectious disease expert Dr. Anthony Fauci a “petty tyrant” and challenged him to a debate on COVID-19.

It's past time Fauci faces the fact that he got COVID wrong. So, doctor to doctor – let's debate. This Doctor is in, are you?” Oz said in a tweet Thursday while posting a campaign ad attacking Fauci

“Let’s get the facts straight here. You and me. Let’s have a debate, doctor to doctor, and give the American people the truth about COVID-19. I’m game. Anytime. Anywhere. Dr. Fauci, are you in?” Oz said in the campaign video.

Fauci has been under attack by Republicans throughout the pandemic, as many in the party disagree with how the country's leading infectious diseases expert has guided the U.S. through the coronavirus. 

Oz said on Newsmax on Thursday that he wants to debate Fauci on vaccine mandates, natural immunity from COVID-19 infections and delays with drugs such as monoclonal antibodies. 

“He is a petty tyrant. He got COVID wrong. He continues to get it wrong,” Oz told the outlet, noting that “doctors like me” think Fauci has not managed the pandemic correctly. 

Oz’s popularity grew out of "The Oprah Winfrey Show,” on which he regularly appeared as a health expert more than a decade ago. 

In 2009, he started "The Dr. Oz Show.” The health-themed talk show will end Jan. 14 as Oz starts his run for office. 

https://thehill.com/policy/healthcare/589709-dr-oz-calls-fauci-a-petty-tyrant-challenges-him-to-debate

LumiraDx Confirms COVID-19 Antigen Test Detects Omicron Variant

 LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced that results from ongoing testing and monitoring of COVID-19 variants show its SARS-CoV-2 Antigen test detects the Omicron Variant. In-house wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity to other variants. In the original U.S. Food and Drug Administration ("FDA") Emergency Use Authorization ("EUA") clinical studies, the test demonstrated 100% agreement with RT-PCR up to Ct 33.0. These latest testing results confirm the company's previous announcement based on in-silico and recombinant protein analysis of the specific mutations in the Omicron variant that it was confident that the performance of its antigen and molecular tests will not be impacted by these mutations.

https://finance.yahoo.com/news/lumiradx-lab-analysis-confirms-covid-111800648.html