Okla. moves into Phase 4 of COVID-19 vaccine plan, opens appointments for all adults

 As thousands of Oklahomans continue to be vaccinated against COVID-19, state health leaders say they are preparing to move on to next and last phase of Oklahoma’s vaccination plan.

So far, the Oklahoma State Department of Health says almost 1.7 million Oklahomans have already received at least one dose of the vaccine.

In all, almost 71% of Oklahomans over the age of 65 have received at least one dose of the COVID-19 vaccine.

Deputy Commissioner of Health Keith Reed says that hospitalizations are steadily declining as vaccine supply grows.

Beginning Monday, March 29, the Oklahoma State Department of Health says they will begin Phase 4 of the distribution plan.

As a result, the COVID-19 vaccine will be open to all Oklahomans who are 16-years-old or older.

“We have all been looking forward to this day for a long time. All Oklahomans will be eligible to schedule a vaccine appointment through the state, regardless of your priority group. No more screening for eligibility groups. No more need for personal contemplation about whether you are eligible or should get the vaccine,” said Reed. “If you are over 16 and live in Oklahoma, you are eligible and should get vaccinated.”

Officials say open vaccine appointments will begin appearing on the state’s portal on Monday, so Oklahomans who have not registered already are encouraged to do so now.

“I want to encourage everyone to schedule an appointment as soon as possible as we look to continue making progress toward a new normal. Our work isn’t done yet,” he added.

As all Oklahomans become eligible to receive the vaccine, authorities say it may be a struggle for some to find open appointments.

Reed suggests visiting the VaccineFinder to locate available appointments around the state if you cannot find an open appointment on the portal.

“Now that there are three vaccines available and our supply is consistent and growing, we are able to continue opening up more access points to make the vaccine readily available around the state,” he said.

Health leaders also stress that even if you have received both doses of the COVID-19 vaccine, your body will not produce the optimal response to the virus until two weeks after that second dose.

At the same time, they say it is not time to let your guard down in public places.

“There are still others around us who might not be vaccinated yet. Let’s continue to mask up in public places, and be mindful of the CDC’s recommendations as the remainder of Oklahomans schedule their appointments,” he said.

Reed says that officials aren’t sure when Oklahoma will reach herd immunity against COVID-19, but that we are making progress toward that goal.

“I want to remind everyone that this pandemic has required a marathon response. We are poised to finish strong, but we haven’t crossed that finish line yet. If you haven’t yet been vaccinated, please take action to do so now. Let’s not leave this virus an opportunity to resurge. Let’s shut it down,” he said.

https://kfor.com/news/watch-oklahoma-state-department-of-health-vaccine-rollout-update/

Texas to Open COVID-19 Vaccination to All Adults on March 29

 All adults will be eligible to receive a COVID-19 vaccine in Texas beginning Monday, March 29. The Texas Department of State Health Services expects vaccine supplies to increase next week, and providers in multiple parts of the state have made great strides in vaccinating people in the current priority groups. The state’s Expert Vaccine Allocation Panel recommended opening vaccination to everyone who falls under the current Food and Drug Administration emergency use authorizations to protect as many Texans as possible.

“We are closing in on 10 million doses administered in Texas, and we want to keep up the momentum as the vaccine supply increases,” said Imelda Garcia, DSHS associate commissioner for laboratory and infectious disease services and the chair of the Expert Vaccine Allocation Panel. “As eligibility opens up, we are asking providers to continue to prioritize people who are the most at risk of severe disease, hospitalization and death – such as older adults.”

DSHS has directed vaccine providers to prioritize people 80 years old or older when scheduling appointments and accommodate anyone in that age group who presents for vaccination, whether or not they have an appointment, by immediately moving them to the front of the line. That will ensure vaccination of anyone 80 or older with as small a burden on themselves as possible.

Also next week, DSHS will launch a website to allow people to register for a shot through some public health providers. The public will be able to enroll in the Texas Public Health Vaccine Scheduler to identify upcoming vaccine clinics hosted by DSHS or a participating local health department and be notified when new clinics and appointments become available. People can continue to find additional providers though the DSHS Vaccine Information page at dshs.texas.gov/covidvaccine.

Online registration will be the best option for most people. For those for whom that is not an option, DSHS will launch a toll-free number to provide assistance making an appointment with a participating provider or locating another provider that has vaccine available.

To date, Texas has administered more than 9.3 million doses of COVID-19 vaccine, equating to more than 6 million people with at least one dose and more than 3 million fully vaccinated. Most vaccines are authorized for people 18 years old and older; the FDA has authorized the Pfizer vaccine for use in people 16 and older.

https://www.dshs.texas.gov/news/releases/2021/20210323.aspx

Data show lockdowns 'end more lives than they save'

 Now that the 2020 figures have been properly tallied, there is still no convincing evidence that strict lockdowns reduced the death toll from COVID-19. But one effect is clear: more deaths from other causes, especially among the young and middle-aged, minorities and the less affluent.

The best gauge of the pandemic’s impact is what statisticians call excess mortality, which compares the overall number of deaths with the total in previous years. That measure rose among older Americans because of COVID-19, but it rose at an even sharper rate among people aged 15 to 54, and most of those excess deaths weren’t attributed to the virus.

Some of those deaths could be undetected COVID-19 cases, and some could be unrelated to the pandemic or the lockdowns. But preliminary reports point to some obvious lockdown-related factors.

There was a sharp decline in visits to emergency rooms and an increase in fatal heart attacks because patients didn’t receive prompt treatment. Many fewer people were screened for cancer. Social isolation contributed to excess deaths from dementia and Alzheimer’s.

Researchers predicted that the social and economic upheaval would lead to tens of thousands of “deaths of despair” from drug overdoses, alcoholism and suicide. As unemployment surged and mental-health and substance-abuse treatment programs were interrupted, the reported levels of anxiety, depression and suicidal thoughts increased dramatically, as did alcohol sales and fatal drug overdoses.

The number of people killed last year in motor-vehicle accidents in the United States rose to the highest level in more than a decade, even though Americans did significantly less driving than in 2019. It was the steepest annual increase in the fatality rate per mile traveled in nearly a century, apparently due to more substance abuse and more high-speed driving on empty roads.

The number of excess deaths not involving COVID-19 has been especially high in US counties with more low-income households and minority residents, who were disproportionately affected by lockdowns. Nearly 40 percent of workers in low-income households lost their jobs during the spring, triple the rate in high-income households.

Minority-owned small businesses suffered more, too. During the spring, when it was estimated that 22 percent of all small businesses closed, 32 percent of Hispanic owners and 41 percent of black owners shut down. Martin Kulldorff, a professor at Harvard Medical School, summarized the impact: “Lockdowns have protected the laptop class of young low-risk journalists, scientists, teachers, politicians and lawyers, while throwing children, the working class and high-risk older people under the bus.”

The deadly impact of lockdowns will grow in future years, due to the lasting economic and educational consequences. The United States will experience more than 1 million excess deaths in the United States during the next two decades as a result of the massive “unemployment shock” last year, according to a team of researchers from Johns Hopkins and Duke, who analyzed the effects of past recessions on mortality. 

Other researchers, noting how educational levels affect income and life expectancy, have projected that the “learning loss” from school closures will ultimately cost this generation of students more years of life than have been lost by all the victims of the coronavirus.

The lockdowns may also have saved some lives, but there’s still no good evidence. When the 50 states are ranked according to the stringency of their lockdown restrictions, you can see one obvious pattern: The more restrictive the state, the higher the unemployment rate. But there is no pattern in the rate of COVID-19 mortality.

More than two dozen studies have challenged the effectiveness of lockdowns, showing that closing businesses and schools does little or nothing to reduce infections and deaths from the virus.

If a corporation behaved this way, continuing knowingly to sell an unproven drug or medical treatment with fatal side effects, its executives would be facing lawsuits, bankruptcy and criminal charges. But the lockdown proponents are recklessly staying the course, still insisting that lockdowns work.

The burden of proof rests with those imposing such a dangerous policy, and they haven’t met it. There is still no proof that lockdowns save any lives — let alone enough to compensate for the lives they end.

John Tierney is a contributing editor of City Journal, from which this column was adapted.

https://nypost.com/2021/03/22/the-data-shows-lockdowns-end-more-lives-than-they-save/

U.S. oil companies launch on-site vaccinations as supplies rise

 U.S. energy companies are organizing employee vaccinations as more COVID-19 doses become available, officials and employees told Reuters, setting up on-site clinics or offering time off to workers to get the shot.

The drive comes as the United States ramps up shipments, with 164.3 million doses sent since rollouts began, and as more companies are encouraging staff to return to offices.

More than a quarter of the U.S. population has received at least one dose, and 45.5 million, of 331 million residents, were fully inoculated as of Tuesday, according to government data.

Energy companies are able to get doses with employees classified as essential workers. Shots are not required but are being made available to staff. Phillips 66 and Exxon Mobil Corp have already begun inoculations, representatives said, and other large energy firms aim to begin shots soon.

Chevron Corp, which received approval to set up clinics, expects supplies in coming weeks from health officials in California and Texas.

"We want our teams together, collaborating, building relationships," Chevron finance chief Pierre Breber said this month. Decisions on returning employees to offices, however, remain to be made, he said.

Exxon has provided on-site vaccinations at U.S. plants, including its second-largest U.S. refinery in Baton Rouge, Louisiana.

The facilities "are classified as essential services and any vaccine distribution will be prioritized to those that have critical roles in maintaining energy delivery and business continuity," said spokesman Jeremy Eikenberry.

Royal Dutch Shell Plc's U.S. pipeline and refinery facilities, including at Deer Park, Texas, have offered the shots, said people familiar with the matter.

Shell did not reply to a request for comment.

Valero Energy Corp has offered plant workers one hour of paid time off per dose, people familiar with the company's policy said.

Valero did not respond to a request for comment.

https://www.marketscreener.com/news/latest/U-S-oil-companies-launch-on-site-vaccinations-as-supplies-rise--32766787/

J&J's large COVID-19 vaccine plant receives FDA authorization

 The Indiana plant at which Catalent Inc is helping to manufacture COVID-19 vaccine for Johnson & Johnson has received U.S. regulatory authorization, the companies said on Tuesday, enabling J&J to ship out millions of doses.

The White House on Tuesday said 27 million COVID-19 vaccine doses will be allocated to U.S. states and other localities this week, including 4 million from J&J.

J&J tapped contract manufacturers Catalent and Emergent BioSolutions Inc to scale up production and meet global supply targets for its COVID-19 vaccine. Catalent provides the final stage - called fill and finish - while Emergent makes the drug substance.

The U.S. Food and Drug Administration authorized the one-shot J&J vaccine in February, but only for its production facility in the Netherlands and a small fill-and-finish plant in the United States.

Based on that authorization, the company shipped nearly 4 million doses in the beginning of March. Shipments dropped sharply since then as J&J awaited the additional authorizations.

The company had previously promised to deliver 20 million vaccine doses by the end of March.

https://www.reuters.com/article/us-health-coronavirus-johnson-johnson-va/jjs-large-covid-19-vaccine-plant-receives-fda-authorization-idUSKBN2BF2MA

Pfizer begins early-stage study of oral COVID-19 drug

 Pfizer Inc has started an early-stage U.S. trial of an oral COVID-19 antiviral therapy that could be prescribed to patients at the first sign of infection, the company said on Tuesday.

The drugmaker, which developed the first authorized COVID-19 vaccine in the U.S. with Germany’s BioNTech SA, said the antiviral candidate showed potent activity against SARS-CoV-2, the virus that causes COVID-19, in lab studies.

Pfizer’s candidate, named PF-07321332, is a protease inhibitor that prevents the virus from replicating in cells.

Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.

Pfizer believes this class of molecules may provide well-tolerated treatments against COVID-19, as currently marketed therapeutics that work on the same lines have not reported safety concerns.

The company is also studying an intravenously administered antiviral candidate in an early-stage trial in hospitalized COVID-19 patients.

“Together, the two (oral and intravenous candidates) have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs,” Pfizer’s Chief Medical Officer Mikael Dolsten said in a statement.

Pfizer’s candidate is behind two other oral antiviral therapies, which are in mid-stage trials – the first being developed by rival Merck & Co with Ridgeback Bio, and a second from Roche Holding and Atea Pharmaceuticals.

Gilead Sciences’ remdesivir is currently the only U.S. Food and Drug Administration-approved drug for the treatment of COVID-19.

The FDA has granted an emergency authorization to intravenous therapies from Eli Lilly - bamlanivimab alone and in combination with etesevimab, and a combination therapy from Regeneron.

https://www.reuters.com/article/us-health-coronavirus-pfizer-antiviral/pfizer-begins-early-stage-study-of-oral-covid-19-drug-idUSKBN2BF22P

Astrazeneca silences its Covid-19 vaccine doubters

 If the previous pivotal studies of Astrazeneca’s Covid-19 vaccine AZD1222 were confusing, the results from its US phase III trial are clear: the vaccine works and does not increase the risk of blood clots.

AZD1222 showed efficacy of 79% in preventing symptomatic Covid-19, rising to 100% against severe disease and hospitalisations. There are still some questions to be answered, including how the vaccine performs against different variants, but the findings will be a boost to Astra after a week that saw many European countries halt its use after fears over thromboses.

Astra plans to file AZD1222 in the US in the first half of April, its head of biopharmaceuticals, Ruud Dobber, said on a media call today. An emergency use authorisation looks like a foregone conclusion given that Johnson & Johnson’s one-shot version of JNJ-78436735 got the go-ahead on apparently weaker data, although the usual caveats about cross-trial comparisons apply.

There will also be pressure on the agency to push AZD1222 through quickly as the US has pre-ordered 300m doses of the Astra jab, on a par with the contribution from Pfizer/Biontech and Moderna. If and when Astra’s shot gets the green light, the company is ready to deliver 30m doses immediately, with another 20m to follow later the same month, Mr Dobber said.

Blood clot fears assuaged

The latest data have important read-across to Europe, where a storm has been raging about blood clot risk. Many EU countries have now started using Astra’s shot again, following a review by the EMA last week that concluded that the benefits of the vaccine outweighed its risks.

However, the agency stopped short of ruling out a link between AZD1222 and blood clots, and a Yougov poll published today shows that confidence in the Astra shot specifically has fallen.

Hopefully, the new US data will go some way towards rehabilitating the jab. The study, in 32,449 participants, found no increased risk of thrombosis among the 21,583 subjects receiving at least one dose of the vaccine. In addition, no cerebral venous sinus thrombosis events were seen.

Another question going into the readout concerned AZD1222’s performance in the over-65s, and here any doubts seem to have been squashed: in this age group the jab’s efficacy was 80%. Around 20% of the trial’s participants were aged 65 or older.

Apart from these nuggets, details were thin on the ground, with Astra merely saying that the interim analysis was based on 141 symptomatic cases of Covid-19. The group did not give a breakdown of how many of these were seen in the vaccine versus the placebo cohorts, and execs dodged several questions about this during today’s briefing.

Mene Pangalos, Astra’s head of biopharmaceuticals R&D, did confirm that five cases of severe Covid-19 had been seen in the placebo arm, compared with none in the vaccine arm. 2:1 randomisation meant that twice as many people in the study received AZD1222 as placebo, and Mr Pangalos said more cases had accrued since the interim analysis.

The Covid-19 case numbers will be closely watched upon publication of the FDA’s briefing documents.

Variants

The biggest unanswered question, though, concerns AZD1222’s efficacy against emerging variants. Astra had no data to share here today, but the trial is sequencing confirmed Covid-19 cases to determine which variant is responsible, with data to be reported “in due course”, a spokesperson told Evaluate Vantage.

Mr Pangalos was optimistic here, given that there were “undoubtedly variants of concern in circulation in this study”. He concluded that the latest data boosted his belief that, “against severe disease, our vaccine will be effective against all variants of concern”.

That said, given data published in the NEJM last week from a South Africa study, hopes cannot be high that AZD1222 will provide high levels of protection against mild to moderate Covid-19 caused by the B.1.351 variant.

As for new vaccines against emerging variants, on which Astra has so far been quiet, the spokesperson said Oxford University had already started developing next-generation candidates, and that the company was also looking at this. 

A final and less pressing question for Astra is what dosing schedule the FDA might recommended. The US trial tested a four-week dosing interval, but in other studies a 12-week schedule has been shown to be more effective.

And Astra stuck to this script, saying that an interval of more than four weeks could increase efficacy beyond that reported today. Some immunogenicity data from the US trial could support this, as there was a cohort of patients whose second dose was delayed when the study was paused last year.

But the decision will ultimately be down to the FDA. For the agency this is probably a nice problem to have, especially given the doubts that had previously swirled around AZD1222.

Selected upcoming Covid-19 vaccine readouts of interest
Company	Project	Trial name/details	N	Timing
Medicago/Glaxosmithkline	CoVLP (coronavirus-like particle Covid-19 vaccine)	US/Canada ph2/3 (NCT04636697)	31,000	Ph2 data due Apr 2021; ph3 portion began Mar 2021
Johnson & Johnson	JNJ-78436735	Ensemble-2, US ph3 (two-dose regimen, NCT04614948)	30,000	Data expected May 2021
Novavax	NVX-CoV2373	Prevent-19, US/Mexico ph3 (NCT04611802)	30,000	Interim data due Q2 2021
Curevac	CVnCoV	Herald, Europe & LatAm ph2/3 (NCT04652102)	36,500	Data due Q2 2021 (from Q1 previously)
		Europe ph3, healthcare workers (NCT04674189)	2,500	Primary completion Jun 2021
Clover/Dynavax	SCB-2019 (Covid-19 S-Trimer)	Europe/ROW ph2/3 (NCT04672395)	22,000	Interim analysis due mid-2021
Sanofi/Glaxosmithkline	SARS-CoV-2 vaccine	Ph2 trial	720	If positive, ph3 to start Q2 2021
Moderna	mRNA-1273.351 (next-gen candidate against S Africa variant)	Ph1 NIAID trial (NCT04785144)	210	Primary completion Aug 2021
Source: Evaluate Pharma & company statements. https://www.evaluate.com/vantage/articles/news/trial-results/astrazeneca-silences-its-covid-19-vaccine-doubters