What 3 Alabama pharmacies learned offering the COVID vaccine

 Shot by shot, three independent Alabama pharmacies have been doing their part to help ease the logjam of people seeking the COVID-19 vaccine in Alabama.

Alabama’s early shipments of vaccine mostly went to large hospitals, smaller regional medical centers and county health departments, with three exceptions: three local pharmacies chosen to receive early doses as a trial run to show that smaller, locally owned pharmacies could help distribute the vaccine, in addition to hospitals, doctors’ offices and health departments.

“We’re kind of the test, because we bill differently than hospitals or physician’s offices,” said Rebecca Sorrell, co-owner of Ritch’s Pharmacy in Mountain Brook, one of the three participating pharmacies.

The other two are the Semmes Pharmacy in Mobile County and the Super Bee Pharmacy in Rainbow City.

Those three pharmacies have combined to give out more than 2,100 doses of the Moderna COVID vaccine since late December, seeing their local stores convert to mini-vaccine clinics hosting dozens of vaccine appointments per day. That’s about 2% of all the doses given in Alabama as of Friday, according to data from the U.S. Centers for Disease Control.

Since offering the vaccine, these pharmacies have experienced long wait times for appointments, floods of calls from the public, and decisions about who to offer a vaccine and how to verify that people signing up are eligible to receive the vaccine. But they all say that overall the operations are running smoothly and they’re happy to do their part to help distribute the vaccine.

“So far, it’s been going really well,” said Mollie Williams, a registered nurse who administers the vaccine at Super Bee in Rainbow City. “We have had a lot of success with it, and our customers have been very grateful.

“We’re just excited to be a part of it, excited that we have the vaccine, and that we’re able to give it to people.”

For Williams and the other staff at Super Bee, the mission to distribute the vaccine is personal. One staff member lost her husband to COVID-19, and the store’s pharmacist, Kim Davis, died of the disease on Thursday.

Williams said Davis got sick in December, just before her pharmacy began offering the vaccine, and her health declined from there. Davis was 53.

“It’s been a lot of heartache,” Williams said. “We’ve just been really trying to, you know, keep our heads up and keep working so that we can provide for everyone, but we’ve also just had a lot of hardships.”

Supplies, space and time are issues

Each pharmacy occupies relatively small, retail spaces, so there are logistics challenges to vaccinating large numbers of people. Each pharmacy said it is vaccinating at least 50 people per day, with Semmes Pharmacy now booking appointments to give out 100 to 120 vaccines per day.

Jessica Hung, a doctor of pharmacy at Semmes Pharmacy, said that’s about the most they can handle with the space they have.

“I think that’s way higher than most independent pharmacies are doing,” she said. “I know, there was a man on Good Morning America who did 50 a day, and they were very proud of that. I think [120 is] a pretty large number. We’re taking three people every 15 minutes.”

At Ritch’s, Sorrell said the pharmacy is booked through the end of February with appointments, with a long waiting list for any cancelled appointments.

She said she’s hopeful that in the near future more pharmacies and medical facilities will begin offering the vaccine and ease the load on those few places now offering the vaccine.

“We’re here trying to do our very best to answer every phone call we can, but we get 300 phone calls a day, we get over 100 either emails, texts or social media messages, [asking] ‘How can I get the vaccine?’” she said. “And we try to answer every one. So it is getting better, but the people just have to be patient.”

At Super Bee, appointments are scheduled every 15 minutes in the afternoon hours.

Right now, Williams said, Super Bee is waiting on its next shipment to arrive before scheduling new appointments.

“We are getting to the end of our first shipment, but they should send us the next one in about a week or so, we hope,” she said. “But we really can’t, we don’t have a definite time, but I would say within a week or two we should be able to pick back up.”

Hard to turn people away

All three pharmacies are sticking to state and federal recommendations about which segments of the population are eligible to receive the vaccine, but appointments are limited.

Early on, that meant healthcare workers and people who were likely to encounter the virus in their job, including mortuary workers. Now that also includes people over 75 and emergency first responders who weren’t included in the initial rounds.

Semmes and Super Bee pharmacies began offering appointments to people over 75 last week. Ritch’s began offering appointments starting Jan. 18, with the rest of the state.

Sorrell said that the Birmingham area has so many healthcare workers that their appointment slots stayed full until then, even as they received hundreds of calls from people seeking the vaccine.

“I feel for each person that calls me, I really do,” Sorrell said. “I feel for them and their story and their 87 year old grandmother, but they’re not the only one in Jefferson County. And so you kind of have to set limits and prioritize as best you can.”

At Super Bee (in Etowah County), Williams said it was difficult to turn away people who want the shot, especially in the initial phase.

“It was hard for us because we had to turn away some of our customers,” Williams said. “But we were so focused on getting all of our health care workers that, you know, some of our older people just had a hard time understanding that we had rules and guidelines to follow.”

Online booking helps

Semmes and Super Bee created online registration systems for people who want to make an appointment to receive the vaccine, and Sorrell said she is in the process of setting up one for Ritch’s. She wishes she had done it earlier.

Sorrell said that after Gov. Kay Ivey’s announcement on Jan. 8 that people over 75 would be eligible to receive the vaccine statewide starting Jan. 18, her phones were flooded with calls and it’s been a problem keeping phones manned and taking appointments.

“We didn’t have any advance warning on that, except just prior to her press conference, so we were inundated with phone calls,” Sorrell said. “And there were people mis-hearing what she said. She said beginning January 18, you can call and make appointments, what they heard was if I’m over 75, I can get a shot now.

“So we had lots of phone calls, people coming into the pharmacy, you know, wanting it now and so we’ve had to take time to explain to people, to calm them down and explain, ‘This is how the system works.’”

The Semmes Pharmacy web site contains a full online booking system where eligible recipients can see a calendar and choose an available time slot, if there are any available. As of Sunday, there were none. The clinic recently opened new appointment slots for February that were snatched up in a matter of hours.

Super Bee uses an online contact form where people can submit their information and the pharmacy will contact them when an appointment is available.

Patients will receive second doses

The Moderna vaccine requires a second dose, recommended to be given 28 days after the first shot. All three pharmacies said they booked appointments with people who received their first dose to receive the second as well, and they say they will honor those appointments, even among the rush of people over 75 looking to get their first shot.

All three pharmacies say the overall experience giving the vaccine has been positive, and that they’re proud to be part of the program and to be among the first to offer the vaccine to their communities.

“We have compliments every day that everything is going well,” Hung said. “It takes the whole store, but we’ve been working well together just trying to make sure that we’re doing the best job we can for people.”

https://www.al.com/news/2021/01/what-3-alabama-pharmacies-learned-offering-the-covid-vaccine.html

Hackers 'manipulated' stolen COVID-19 vaccine data before leaking it online

 Hackers who stole information about COVID-19 vaccines in a cyberattack against the European Union's medical agency and then published it online also manipulated what they found in order to spread disinformation designed to undermine trust in vaccines.

In the latest update on the cyberattack which was first disclosed last month, the European Medicines Agency (EMA) has revealed how hackers accessed confidential internal emails from November about evaluation processes for COVID-19 vaccines.

The ongoing investigation found that some of the contents of those emails has been manipulated by those behind the attack in what appears to be an attempt to create mistrust with disinformation about vaccines.

"Some of the correspondence has been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines," said the update from the EMA.

It's uncertain who the perpetrators of the EMA cyberattack are or why exactly they've manipulated the documents to spread disinformation in an effort to undermine trust in the vaccines. Anti-vax conspiracy theories about coronavirus have been a problem for social media and the wider world since the start of the pandemic.

A previous update from the EMA disclosed that hackers accessed and stole COVID-19 vaccine data during the December attack. The intruders, who were specifically targeting data relating to COVID-19 medicines and vaccines gained access to the formation by breaching an undisclosed IT application.

"The agency continues to fully support the criminal investigation into the data breach. Necessary action is being taken by the law enforcement authorities," said the EMA statement.

The UK's National Cyber Security Centre, Microsoft and the World Health Organisation are among those which have issued warnings over hacking groups targeting healthcare, pharmaceuticals, universities and other organisations involved in COVID-19 vaccine development and distribution.

https://www.zdnet.com/article/hackers-manipulated-stolen-vaccine-data-before-leaking-it-online/

Cal. stops use of COVID-19 vaccine batch after allergic reactions in San Diego

 State health leaders are recommending vaccine providers stop using a batch of Moderna COVID-19 vaccines after a few suspected allergic reactions at a San Diego vaccination site.

The California Department of Public Health said fewer than 10 people reported reactions after getting vaccines from Moderna Lot 041L20A at Petco Park last week. They sought medical attention in the 24 hours after getting the doses.

“All appeared to be experiencing a possible severe allergic reaction during the standard observation period – a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine. The vaccine site switched to another lot of Moderna vaccine after closing for a few hours,” the health department said in a news release Sunday.

The mass vaccination site at Petco Park opened on Jan. 11 with vaccines available to healthcare workers in the Phase 1A-Tier categories on California’s priority list.

fficials said more than 330,000 doses from the Moderna lot were distributed to 287 providers in California. Health leaders have not been notified of any other reactions related to the batch.

“Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory,” the news release said.

The release went on to say no vaccine or medical procedure is without risk and the chance of a serious adverse reaction is very small. While limited data exists on adverse reactions to the Moderna vaccine, a similar vaccine shows the expected rate of anaphylaxis is approximately 1 in 100,000, state health leaders said.

The manufacturer, CDC and FDA are reviewing the batch and related medical information. The state says they expect to learn more this week. Replacement doses are not immediately available during the pause.

The FDA previously noted side effects from the Moderna vaccine in a few trial participants who had cosmetic facial fillers in their cheeks and lips.

The state said providers of the COVID-19 vaccine should continue their routine precautions to recognize and manage allergic reactions and potential adverse events.

https://fox5sandiego.com/news/california-news/state-pauses-use-of-moderna-vaccine-batch-after-allergic-reactions/

Fact Sheet: Activity at the Wuhan Institute of Virology

 FACT SHEET

OFFICE OF THE SPOKESPERSON

JANUARY 15, 2021

For more than a year, the Chinese Communist Party (CCP) has systematically prevented a transparent and thorough investigation of the COVID-19 pandemic’s origin, choosing instead to devote enormous resources to deceit and disinformation. Nearly two million people have died. Their families deserve to know the truth. Only through transparency can we learn what caused this pandemic and how to prevent the next one.

The U.S. government does not know exactly where, when, or how the COVID-19 virus—known as SARS-CoV-2—was transmitted initially to humans. We have not determined whether the outbreak began through contact with infected animals or was the result of an accident at a laboratory in Wuhan, China.

The virus could have emerged naturally from human contact with infected animals, spreading in a pattern consistent with a natural epidemic. Alternatively, a laboratory accident could resemble a natural outbreak if the initial exposure included only a few individuals and was compounded by asymptomatic infection. Scientists in China have researched animal-derived coronaviruses under conditions that increased the risk for accidental and potentially unwitting exposure.

The CCP’s deadly obsession with secrecy and control comes at the expense of public health in China and around the world. The previously undisclosed information in this fact sheet, combined with open-source reporting, highlights three elements about COVID-19’s origin that deserve greater scrutiny:

1. Illnesses inside the Wuhan Institute of Virology (WIV):

• The U.S. government has reason to believe that several researchers inside the WIV became sick in autumn 2019, before the first identified case of the outbreak, with symptoms consistent with both COVID-19 and common seasonal illnesses. This raises questions about the credibility of WIV senior researcher Shi Zhengli’s public claim that there was “zero infection” among the WIV’s staff and students of SARS-CoV-2 or SARS-related viruses.
• Accidental infections in labs have caused several previous virus outbreaks in China and elsewhere, including a 2004 SARS outbreak in Beijing that infected nine people, killing one.
• The CCP has prevented independent journalists, investigators, and global health authorities from interviewing researchers at the WIV, including those who were ill in the fall of 2019. Any credible inquiry into the origin of the virus must include interviews with these researchers and a full accounting of their previously unreported illness.

2. Research at the WIV:

• Starting in at least 2016 – and with no indication of a stop prior to the COVID-19 outbreak – WIV researchers conducted experiments involving RaTG13, the bat coronavirus identified by the WIV in January 2020 as its closest sample to SARS-CoV-2 (96.2% similar). The WIV became a focal point for international coronavirus research after the 2003 SARS outbreak and has since studied animals including mice, bats, and pangolins.
• The WIV has a published record of conducting “gain-of-function” research to engineer chimeric viruses. But the WIV has not been transparent or consistent about its record of studying viruses most similar to the COVID-19 virus, including “RaTG13,” which it sampled from a cave in Yunnan Province in 2013 after several miners died of SARS-like illness.
• WHO investigators must have access to the records of the WIV’s work on bat and other coronaviruses before the COVID-19 outbreak. As part of a thorough inquiry, they must have a full accounting of why the WIV altered and then removed online records of its work with RaTG13 and other viruses.

3. Secret military activity at the WIV:

• Secrecy and non-disclosure are standard practice for Beijing. For many years the United States has publicly raised concerns about China’s past biological weapons work, which Beijing has neither documented nor demonstrably eliminated, despite its clear obligations under the Biological Weapons Convention.
• Despite the WIV presenting itself as a civilian institution, the United States has determined that the WIV has collaborated on publications and secret projects with China’s military. The WIV has engaged in classified research, including laboratory animal experiments, on behalf of the Chinese military since at least 2017.
• The United States and other donors who funded or collaborated on civilian research at the WIV have a right and obligation to determine whether any of our research funding was diverted to secret Chinese military projects at the WIV.

Today’s revelations just scratch the surface of what is still hidden about COVID-19’s origin in China. Any credible investigation into the origin of COVID-19 demands complete, transparent access to the research labs in Wuhan, including their facilities, samples, personnel, and records.

As the world continues to battle this pandemic – and as WHO investigators begin their work, after more than a year of delays – the virus’s origin remains uncertain. The United States will continue to do everything it can to support a credible and thorough investigation, including by continuing to demand transparency on the part of Chinese authorities.

https://www.state.gov/fact-sheet-activity-at-the-wuhan-institute-of-virology/

1 in 8 recovered COVID-19 patients reportedly die within 5 months

 Almost a third of recovered COVID-19 patients end up back in the hospital within five months — and up to one in eight die of complications from the illness, according to a report.

Researchers at the UK’s Leicester University and the Office for National Statistics found that out of 47,780 people discharged from the hospital, 29.4 percent were readmitted within 140 days, the Telegraph reported.

Of the total, 12.3 percent succumbed to the illness, it added.

Many people who suffer long-lasting effects of the coronavirus develop heart problems, diabetes and chronic liver and kidney conditions, according to the report.

“People seem to be going home, getting long-term effects, coming back in and dying. We see nearly 30 percent have been readmitted, and that’s a lot of people. The numbers are so large,” study author Kamlesh Khunti said.

“The message here is we really need to prepare for long COVID. It’s a mammoth task to follow up with these patients and the NHS is really pushed at the moment, but some sort of monitoring needs to be arranged,” added Khunti, a professor of primary care diabetes and vascular medicine at Leicester University.

The study — which Khunti described as the largest of people discharged from a hospital after being admitted with COVID-19 — found that survivors were nearly 3½ times more likely to be readmitted, and die, in 140 days than other outpatients.

Khunti said the researchers were surprised that many people were readmitted with a new diagnosis, adding that it was important to make sure people were placed on protective therapies, including statins and aspirin.

“We don’t know if it’s because COVID destroyed the beta cells which make insulin and you get Type 1 diabetes, or whether it causes insulin resistance, and you develop Type 2, but we are seeing these surprising new diagnoses of diabetes,” he said.

“We’ve seen studies where survivors have had MRS scans and they’ve cardiac problems and liver problems,” Khunti added. “These people urgently require follow-up and the need to be on things like aspirin and statins.”

The new study was published on a pre-print server and has not yet been peer reviewed.

https://nypost.com/2021/01/18/1-in-8-recovered-covid-19-patients-die-within-5-months-study/

Trump administration will let nearly all doctors prescribe addiction med buprenorphine

 The Trump administration announced a major shift in addiction medicine policy Thursday, giving doctors dramatically more flexibility to prescribe a popular and effective drug used to treat opioid use disorder.

The change will allow almost all physicians to prescribe the addiction drug buprenorphine, regardless of whether they’ve obtained a government waiver. Previously, doctors had to undergo an eight-hour training and receive the license, known as the “X-waiver,” before they could prescribe buprenorphine. For years, addiction treatment advocates have argued that tight buprenorphine regulations prevent thousands of doctors from providing high-quality addiction care.

The announcement represents a sea change in addiction medicine during the final days of the Trump administration.

Some drug policy officials have long resisted the deregulation of buprenorphine, citing its status as a controlled substance. But in a Thursday press briefing, assistant health secretary Brett Giroir told reporters that the rising level of drug overdoses in recent years, and especially in light of the Covid-19 pandemic, compelled the administration to act.

“Many people will say this has gone too far, but I believe more people will say this has not gone far enough,” Giroir said. “This is a measured, logical, appropriate, evidence-based, and patient-centered intervention that may save tens of thousands of lives.”

The new policy will allow any physician with a Drug Enforcement Administration prescriber license to treat up to 30 in-state patients with buprenorphine. Hospital-based physicians will be exempted from the 30-patient cap, and doctors can still treat up to 275 patients with the drug if they undergo the training and receive a separate waiver. It does not impact nurse practitioners or physician assistants, who will still need to apply for separate waivers to earn buprenorphine prescribing privileges.

As of now, only 66,000 physicians and another 25,000 prescribers like NPs or PAs have an X-waiver, Giroir said.

Numerous researchers, doctors, addiction treatment advocates, and members of Congress have long advocated for eliminating the waiver and allowing physicians to prescribe buprenorphine as they would any other drug. One common argument: Doctors who prescribe potentially addictive opioids should be permitted to treat the addictions that sometimes develop.

A bill introduced in 2019 by Rep. Paul Tonko (D-N.Y.) that would have eliminated the X-waiver had 117 House co-sponsors, including 23 Republicans. Giroir cited the bipartisan support for buprenorphine deregulation, but acknowledged Congress hasn’t yet passed a bill. He said Covid-19 created an “urgent need” that meant waiting wasn’t an option.

“Nullifying this waiver requirement and making it easier for physicians to prescribe buprenorphine, even to a limited number of patients, will save countless lives,” Tonko said in a statement.

Health secretary Alex Azar implemented the new policy by issuing an update to practice guidelines for buprenorphine treatment. Since they are not codified in a new law or in a federal regulation, the new guidelines are easily reversible. The incoming Biden administration, however, is seen as sympathetic to the changes and unlikely to reverse them. “I doubt it seriously,” Giroir said.

The change represents one of the biggest addiction policy overhauls in President Trump’s four-year term. It is also likely the final major policy initiative put into effect by Giroir, Azar, and director of national drug policy Jim Carroll, all of whom will leave office on Jan. 20 upon President-elect Biden’s inauguration.

The move earned quick support from doctors. In a statement, the American Medical Association lauded the effort, citing estimates that though over 2 million Americans need treatment for opioid addiction, few receive quality care.

“The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder,” Patrice Harris, the organization’s former president, said in a statement. “Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it.”

https://www.statnews.com/2021/01/14/trump-admin-nearly-all-doctors-buprenorphine/

Ex-FDA chief Kessler controversial pick to head Operation Warp Speed

 President-elect Biden has tapped David Kessler, a former Food and Drug Administration chief and a key adviser to his campaign, to lead the president-elect’s version of the Operation Warp Speed vaccine program, a Biden official told STAT.

Kessler is something of a controversial choice. His list of accomplishments at the FDA — he pushed the agency to expand its role to regulate tobacco, he implemented the user fee system and the adverse event reporting system — is long and bold. But until he began advising the Biden campaign on the pandemic, he had not worked in government for more than 20 years, since serving as Clinton’s FDA commissioner.

Kessler also does not have a background in vaccine development, or in mass vaccination campaigns: Since leaving the government in the 1990s, he has served as dean of two medical schools and written extensively about nutrition. Nonetheless, Kessler has become one of Biden’s most trusted pandemic advisers and has been meeting behind-the-scenes with countless companies offering to help with the vaccine development effort, including those that don’t have an existing contract with the Operation Warp Speed.

Kessler is also serving as co-chair of Biden’s Covid-19 task force and medical adviser for Biden’s inaugural committee.

Kessler will replace Moncef Slaoui, a former pharmaceutical industry executive tapped by Trump for the job, the New York Times first reported. Kessler’s duties will have a larger remit than Slaoui’s previous role as chief adviser to Operation Warp Speed, a transition official told STAT. Where Slaoui focused largely on clinical development of vaccines, Kessler will also work on issues like manufacturing, distribution, and safety.

It’s still unclear exactly how Kessler will split duties with Gen. Gustave Perna, who is Operation Warp Speed’s chief operating officer under Trump. Perna is expected to continue to serve in some capacity during the Biden administration.

Slaoui’s ties to the industry made him controversial with some prominent Democrats; Sen. Elizabeth Warren (D-Mass.) even pushed for his firing. Slaoui, however, will stay on as a consultant under the Biden administration, with a diminished role, to help the transition.

A Biden campaign press release lists Kessler’s new title as chief science officer of COVID Response.

Kessler will take on a major challenge at Operation Warp Speed, which has fallen dramatically short of Slaoui’s original goal to vaccinate 20 million people by the end of last year. Biden has promised to administer 100 million doses within his first 100 days, a goal that even his advisers admit is “aspirational … but doable.”

It’s not immediately clear how Kessler will transform the vaccine effort: The former FDA commissioner has kept a strikingly low public profile over the past months. His few media appearances have largely centered around assuring the American public that coronavirus vaccines are safe and effective.

Kessler was long rumored as one of the top picks for FDA commissioner in the Biden administration. The most likely contenders for that role now, according to current and former FDA officials, are Josh Sharfstein, who served as second-in-command at the FDA in the Obama administration, and Janet Woodcock, the longtime head of FDA’s drug center.

The Biden campaign announced a slew of additional appointments to the Covid-19 vaccine effort Friday as well. They include former acting Centers for Medicare and Medicaid Services administrator Andy Slavitt, who will serve as senior adviser to the COVID Response coordinator; Yale Law School professor Abbe Gluck, who will serve as special counsel; and University of Virginia professor B. Cameron Webb, who will serve as senior policy adviser for Covid-19 equity.

https://www.statnews.com/2021/01/15/david-kessler-help-lead-operation-warp-speed-for-biden/