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Sunday, January 24, 2021

The Covid Vaccine Ad Void

 On Interstate 59, a neon billboard used by the Alabama Department of Public Health advises motorists to get their flu and pneumonia vaccines. Placards placed atop gas pumps around the state also promote the flu vaccine.

But the vaccine that will quell COVID-19, a virus that has killed 400,000 nationwide, crippled businesses and prompted governments to force onerous restrictions the public, gets no mention. 

Karen Landers, a spokeswoman for the Alabama Department of Health, said the state has “no specific marketing campaign going on” because “the vaccine supply is less than the demand, here and nationwide.”

Alabama, though, has plenty of medicine and many residents wondering how to get it.  Records show that the state has received 444,000 doses of the vaccine as of Friday, and has vaccinated 100,000 people, using around 23% of its allotted doses.

Across the U.S., 31 million doses of the COVID vaccine have been distributed as of Friday, according to the Centers for Disease Control and Prevention, while states have administered 12 million, around 38%.  The vaccine produced by pharma giants Moderna and Pfizer are two-dose treatments that provide up to 95% protection.

The failure of Alabama and other states around the country to launch vaccine advertising campaigns – touting the medicine’s efficacy and informing people how and where they can receive it – is creating potentially life-threatening confusion.

President-elect Joe Biden has pledged to spend more money on vaccinations, allocating $400 billion in a plan that includes using local pharmacies (a feature borrowed from the Trump administration) and mass vaccination centers.  Biden said the push will include a public awareness campaign aimed at promoting the importance of getting inoculated.

But for now the lack of advertising is striking because local and federal government agencies routinely spend large sums on public health campaigns – including warning people how to behave in response to COVID-19.  

The Obama administration spent $684 million driving awareness of the Affordable Care Act starting in 2013, although it was dogged by the rollout of a federal web portal widely viewed as disastrous. The pharmaceutical industry spent $9.5 billion on digital advertising alone in 2020, according to researcher eMarketer.

Hard-to-Reach Audiences

One of the challenges of the covid vaccine, as with Obamacare, is connecting with people who are hard to reach, including those without Internet service or who aren’t avid news followers.

Yet while the vaccine is in the early stages of distribution, information on what it does and how to get it can only be found at the websites of state and county health departments.

By contrast, when the virus emerged last spring, local governments quickly took to the airwaves with ads urging people to “stay home, stay safe,” collectively spending millions of dollars on multi-platform announcements, including government-produced signage distributed to businesses notifying  patrons that masks were required for entry.

The lack of comparable information about the vaccine is contributing to supply and demand mismatches.

When a Walgreens in Louisville, Ky., found itself sitting on vaccine ready to expire, it made a public announcement that anyone could get the vaccine. The store was subsequently overwhelmed.

For that last-minute move, the store was criticized by Democratic Gov. Andy Beshear, who said the vaccine needed to be held for people who deserve it in accordance with CDC guidelines.

In Michigan, under some of the most onerous shutdowns in the U.S. ordered by Democratic Gov. Gretchen Whitmer, the lack of an information campaign has confused the public.

“No one here even knows that there is a vaccine available,” said Joel Fragomeni, a Detroit-based comedian who volunteered for AstraZeneca’s clinical trial of its COVID vaccine, which is expected to be approved in the spring. “People are still mostly locked down waiting for the weekly cases report to see what can be opened and closed.” 

States were presented in October with a 57-page guide to prepare distribute the vaccine, including two pages devoted to how to drive awareness among the public.  

Among the suggestions: “Keep the public, public health partners, and healthcare providers well-informed about COVID-19 vaccine(s) development, recommendations, and public health’s efforts.” 

It is not clear why the states or the federal government have been slow to advertise availability. Some experts say the unprecedented speed with which the medicine was developed may have caught authorities unprepared as they were preoccupied with other aspects of the pandemic.

In addition, broad confusion over who should get the first available doses has made messaging difficult.

Scant Spending on Vaccine Awareness

In Illinois, Gov. J.B. Pritzker’s office in August signed off on a $5 million ad campaign to promote masking. But the governor’s website homepage makes no mention of the vaccine, listing only new positive case rates.  The state is sitting on 43% of the 1 million vaccine doses it has received and has yet to spend anything on vaccine awareness.

New York City in April launched a $10 million campaign advising residents how to behave as the virus spread. The state launched an additional campaign in July urging residents to wear masks.

New York has used less than half the vaccine it has been given, as people seek information on how and where to sign up to receive a dose.

California spent millions on billboards, social media and broadcast spots in July telling people to wear masks and keep away from each other, promoting the campaign in a press release on Gov. Gavin Newsom’s home page. 

Newsom’s office last issued a statement on the vaccine in late December, noting that California would partner with CVS and Walgreens to inoculate residents of long-term care facilities. Since then, information has been so scarce that residents have begun to crowdsource details.

The Ad Council and the CDC continue to run 60-second announcements on CNN’s Headline News urging people to stay home, avoid businesses like restaurants and bars and distance from each other.

National television spots urging viewers to get a vaccine for shingles – which kills roughly 100 people a year -- are in full rotation in places like the Weather Channel.  

The Ad Council, a consortium of private firms started during World War II that produces ads for the public good, has co-produced ads since the beginning of the pandemic advising people to stay home, keep away from each other and wear masks. In November it promised a $50 million campaign to drive awareness of the vaccine.

Last week, the council announced it had not yet met that goal, although it promised a campaign was forthcoming.

In an email, Ad Council spokesman Ben Dorf said that “even while many Americans have already started the vaccination process – we recognize that there is currently a lack of confidence and credible resources for people to go to, leading to mass hesitation, fear, misinformation and complacency.”

Polls show many Americans are reluctant to take a vaccine, with the perhaps most politically opportunistic naysayer being Vice President-elect Kamala Harris, who in October said she wouldn’t take it if President Trump were telling her to. She was vaccinated in December.

Dorf promised advertising in the future, although he specified no time.

“This is the biggest issue of our lifetime and it requires an effort like never before, in terms of size, scale, speed and urgency,” he wrote.

Emails to the CDC were referred to the U.S. Department of Health & Human Services, which did not respond.

Pfizer, Moderna, Walgreens and CVS did not respond to calls and emails requesting information on marketing plans for the vaccine.

https://www.realclearinvestigations.com/articles/2021/01/20/the_vaccine_ad_void_what_we_have_here_is_a_failure_to_communicate_126830.html

EU says it will make vaccine companies respect supply contracts

 The European Union will make pharmaceutical companies respect contracts they have signed for the supply of COVID-19 vaccines, European Council President Charles Michel said on Sunday.

Pfizer Inc last week said it was temporarily slowing supplies to Europe to make manufacturing changes that would boost output. On Friday, AstraZeneca also said that initial deliveries to the region will fall short because of a production glitch.

"We plan to make the pharmaceutical companies respect the contracts they have signed ... by using the legal means at our disposal," Michel said on Europe 1 radio.

He did not mention possible sanctions but said that the EU would insist on transparency about the reasons for the delays.

He said that after Pfizer's first warnings about delays of several weeks, the EU had managed to reduce these delays by taking a tough stance.

"We banged our fist on the table and finally announced delays of several weeks turned into a slowdown of deliveries," he said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-EU-says-it-will-make-vaccine-companies-respect-supply-contracts-Michel-32263244/

Saturday, January 23, 2021

J&J COVID Vaccine Gets Unique CPT Code Even Before FDA Filing

 The largest US physician organization has created a billing code for what's expected to be the nation's third COVID-19 vaccine, moving ahead of an anticipated regulatory filing for emergency clearance of the product.

The American Medical Association (AMA) on Tuesday said the Current Procedural Terminology (CPT) code set has been updated to include the Johnson & Johnson (J&J) /Janssen vaccine, which has been assigned the code 91303.

New Brunswick, New Jersey–based J&J is awaiting phase 3 data from a study of its single-dose vaccine, which could be available as early as late January, a company spokesman told Medscape Medical News on Wednesday.

If the vaccine continues to appear to be safe and effective, J&J will file with the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of the vaccine "shortly" after seeing these data. The FDA in December granted EUAs for two COVID-19 vaccines — the first from the Pfizer-BioNTech collaboration and the second from Moderna Inc.

J&J's single-dose vaccine would mark "a big change" from the Pfizer-BioNTech and Moderna vaccines, which are given in two-dose regimens, noted AMA President Susan R. Bailey, MD, in a statement.

"The change will place greater importance on accurately reporting COVID-19 immunizations by vaccine type and dose to ensure patients complete the appropriate immunization schedule," Bailey said. "Unique CPT codes that clinically distinguish each COVID-19 vaccine provide the needed informational precision to ensure optimal vaccine distribution and administration."

The New England Journal of Medicine published interim phase 1/2a trial results January 13 for J&J's vaccine. After a single vaccination, neutralizing antibodies against COVID-19 were detected in more than 90% of study participants at day 29, Jerald Sadoff, MD, and coauthors reported.

It is expected that an EUA clearance for the single-dose J&J product might significantly boost the overall number of immunizations available against COVID-19, Medscape Medical News reported.

The AMA also created CPT codes for the Pfizer-BioNTech and Moderna vaccines before the FDA granted EUAs for them.

https://www.medscape.com/viewarticle/944565

BioNTech Investor, Amid Shortage Worry, Vows Vax Delivery for 2nd Shot

 European countries should use all available vaccine doses provided by biotech firm BioNTech and its partner Pfizer because there will be enough for the requisite second booster shot due to a planned production ramp-up, BioNTech's largest investor said.

Some countries were believed to be withholding some vaccines for fear of a shortage for the required second dose, meant to be administered three weeks after the first vaccination.

Pfizer said last week it would have to reduce deliveries of the shots to Europe until early February in order to upgrade production capacity for a later output boost.

Speaking in an interview with monthly Manager Magazin, the managing director of the investment vehicle of biotech investors Thomas and Andreas Struengmann, who hold about half the shares in BioNTech, said Denmark was taking the delivery cuts in its stride and was not withholding any volumes for the second booster dose of the two-shot regimen.

"Denmark, for example, is being a role model," said Helmut Jeggle, head of the Struengmann brothers' holding company Athos, told the magazine, when asked why Europe was falling behind in its vaccination campaign.

He said in parts of Germany, half of the apportioned vaccine doses were stored to reserve a booster shot for every recipient of the first shot within the prescribed three-week interval.

"That degree of stock keeping is not necessary because we will do everything to really deliver the committed volumes in the first quarter, irrespective of some hiccups at the Belgian site in Puurs for one or two week," Jeggle was quoted as saying.

https://www.medscape.com/viewarticle/944477

New CDC head: COVID-19 vaccine for general public not likely by March

 With the first full day of President Joe Biden's administration underway, the new director of the Centers for Disease Control and Prevention, Dr. Rochelle Walensky, is sharing what she believes is a realistic timeline for overcoming the many challenges of the COVID-19 vaccine rollout thus far.

On Thursday morning, Walensky and TODAY co-anchor Savannah Guthrie dove into the administration's plan to have 100 million doses of COVID-19 vaccine administered within the first 100 days of Biden taking office.

"We recognize this as the most immediate emergency to get this country back to health," Walensky said. She added that yesterday marked one year since the first COVID-19 case in the U.S. and that if the the country continues with its current pace of new cases, there will be 100,000 more deaths by the middle to end of February.

Addressing the challenges of vaccine distribution, which range from vaccine hesitancy among the population to shortages of doses in states like New York, she explained that the priority is matching "the amount of vaccine that we have for the amount of people who are eligible so we don't have vaccine on the shelves and ... don't see the footage of these long lines."

"We really need to ... expand our (vaccine) eligibility so it fits with the vaccine supply," she added.

She also hopes the new administration can rally more vaccinators to help get more shots in more people's arms. "We need to make sure ... that we have commissioned health corps, medical military, retirees, medical students and nursing students just about to graduate, dentists and veterinarians in order to be out there to vaccinate the public," Walensky explained.

Asked by Savannah about where the issues with the vaccine supply chain exist, she said that the administration is working closely with the head of Operation Warp Speed, Gen. Gustave Perna, as well as vaccine manufacturers and state officials. She said they're seeking to answer questions like, "Do we need syringes or do we need chemical products?" but at this stage, distributing vaccines currently sitting on shelves is a higher priority.

"We're looking at community vaccination centers, stadiums and gymnasiums," Walensky said. "We're looking at mobile units to really get to every corner of this country, federally qualified health care centers and pharmacies."

She called it a "diverse" rollout plan "so we can get to all people," and also stressed the importance of understanding vaccine hesitancy.

"Vaccine hesitancy comes in numerous different flavors, I will say," Walensky continued. "Some people just really need it to be convenient. Some people need to have permission to take the time to get the vaccine or enough leeway to be able to take the day off if they're feeling unwell the next day. Some of it is they just want to see how it's going to go. Some of it is education ... and we need to bring that science to them by their trusted people."

Last, Walensky addressed a comment made by the Trump administration's Health and Human Services Secretary Alex Azar, who told Savannah in December that he thought the COVID-19 vaccine could be as widely available to the general population as the flu shot by late February or early March.

"I don't think late February we're going to have vaccine in every pharmacy in this country," Walensky said. "We said 100 million doses in the first 100 days, and we're going to stick to that plan, but also want to be very cognizant of the fact that after 100 days, there are still a lot of Americans who need vaccine, so we have our pedal to the metal to make sure we can get as much vaccine out there."

She added that a third drug maker, Johnson & Johnson, whose COVID-19 vaccine only requires one shot as opposed to Moderna's and Pfizer's two doses, could soon be on the path to seeking authorization from the Food & Drug Administration.

https://www.today.com/health/new-cdc-director-dr-rochelle-walensky-talks-vaccine-rollout-today-t206492

Ohio funeral homes at breaking point, workers want COVID-19 vax

 Ohio’s funeral home workers are sounding the alarm and pleading with state leaders to put them on the coronavirus vaccination list.

According to Ohio’s Funeral Directors Association, which represents 85% of funeral homes across the state, many are at or near their breaking point because of the COVID-19 pandemic.

The surge in COVID-19 deaths has more than doubled the typical call volume at both large and small nursing homes.

While the staff is continually exposed to the virus going to hospitals, nursing homes, and private residences.

“There are multiple touch points where they have the opportunity for exposure,” said Sullivan, “Then back at the funeral home preparing the individual for their services, meeting with the family and  even if it’s a small service they have those additional individuals inside their funeral homes.”

Some funeral homes are currently working with only 25% of their staffing due to infections and quarantining.

Jim Busch, President of Busch Funeral Homes said, “Our staff has been absolutely amazing just sacrificial what they’ve done, and continue to do and that’s why I’m so concerned about getting on a faster track for  the vaccine so we can protect our staff so we can be here to serve these great communities that we’re in.”

However, he says they too are exhausted and hoping the state will allow them to get vaccinated.

“It would mean so much to our staff so much to our families of our staff,” said Busch, “Protecting our families so we can continue to serve families.”

The OFDA has been communicating with both the Ohio Department of Health and Governor’s Administration.

Sullivan points out that the CDC’s Advisory Council on Immunization Practices recommends “death care workers” get vaccinated in Phase 1A.

She says dozens of states have prioritized them and hope Ohio will too before it’s too late.

She says, the funeral service workforce was already limited before the pandemic and there is no contingency plan to add additional licensees.

“We’re hopeful that they will recognize this small critical population and the need to keep them healthy so we can continue serving families,” said Sullivan. 

https://fox8.com/news/coronavirus/ohio-funeral-homes-at-breaking-point-workers-want-covid-19-vaccine/

Montreal Heart Institute: Colchicine tablet effective in Covid

 An extensive study launched by the Montreal Heart Institute last March has concluded the anti-inflammatory medication colchicine can reduce some of the complications associated with COVID-19.

In a news release issued Friday, the institute described its findings as a “major scientific discovery” that could help millions of COVID-19 patients around the world.

Colchicine, an oral tablet that’s inexpensive and easy to make, is already known and used for other diseases. The study looked at its effects on 4,159 COVID-19 patients.

Patients involved needed to be over the age of 40 and have at least one risk factor for possible complications. The results showed the medication helped reduce hospitalizations by a quarter, the need for mechanical ventilation by half and deaths by 44 per cent.

Researchers involved believe colchicine could become the first oral medication to be used to treat non-hospitalized COVID-19 patients.

In a statement, Dr. Jean-Claude Tardif, director of the MHI Research Center, said the medication could have a “significant impact on public health and potentially prevent COVID-19 complications for millions of patients.”

The institute said prescribing colchicine to patients could also help lower the number of people hospitalized with COVID-19 and “reduce healthcare costs here and around the world.”

Called “COLCORONA,” the clinical trial was conducted in Canada, the United States, Europe, South America and South Africa.

The institute had received a $3-million grant to fund the trial in May.

https://montrealgazette.com/news/local-news/covid-19-montreal-heart-institute-concludes-colchicine-is-effective