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Thursday, January 28, 2021

'Natural Immunity' to COVID-19: Taking Politics Out of Science

 "Natural immunity" to COVID-19 reinfection has become a political hot-button issue, due in part to groups such as the Great Barrington Declaration organizers. In the first part of this exclusive MedPage Today video, Monica Gandhi, MD, of the University of California San Francisco, discusses the evidence with MedPage Today editor-in-chief Marty Makary, MD, of Johns Hopkins University in Baltimore, and speaks about whether individuals who were previously infected with COVID-19 should be vaccinated when there are so many vulnerable populations who are still at risk of severe disease.

Marty Makary: Hi, I'm Marty Makary. I'm here with Dr. Monica Gandhi, a professor of medicine and infectious diseases physician at UCSF. Monica, great to be with you.

Monica Gandhi: Thank you so much. Nice to be with you.

Makary: I have got so many questions for you, just with you being at the center of so much of this area. First of all, let's talk about natural immunity from prior infection, something that I think many experts have been dismissive of. Why are we vaccinating first-in-line people who have already had the infection? I'm still trying to understand why we don't clarify that they should step aside and get to the back of the vaccine line when reinfection rates appear to be very rare, and when they do occur, they're very mild.

Gandhi: Yes, so you're absolutely right about that. Immunity to natural infection is like something we learned on the first day of medical school, this is not mysterious. That's entirely how the immune system works and so we expected that you would get immunity after natural infection. Now we have incredible data on that, which we can talk about. But it is amazing that immunity became politicized to the degree it did, that people went so far as to say, "Don't consider that you're going to get immunity to natural infection," because of this Great Barrington-John Snow debate that came out, and neither one was correct.

There was probably a middle ground where it is accurate that protecting our elderly, and 40% of our deaths in this country were nursing home residents, was the most important thing we could do. It is correct that immunity develops and that it means a lot, and it is also correct that lockdowns have terrible economic effects on the poor and the young. This has been going on for a long time.

The Great Barrington Declaration was also incorrect in not saying that masks were a good idea because they didn't bring in masks or non-pharmaceutical interventions into their discussion. They actually, literally, said more like, "Let it rip," and certainly we want to protect people from severe disease.

Makary: Dr. Atlas had sort of suggested, possibly, that maybe that's a strategy, that we should sort of let it rip among those who are not vulnerable, and I think -- why is it, Monica, that if you believe in the scientific data that says natural immunity is highly protective, at least in the first year for which we have data, that that somehow is married to the idea of "let it rip," which I would never suggest?

Gandhi: Correct.

Makary: And I'm open to your thoughts. We shouldn't just let it rip.

Gandhi: We should never let it rip.

Makary: Absolutely.

Gandhi: Right.

Makary: But somehow if you believe in natural immunity, that has become sort of married to this idea that you should let it rip.

Gandhi: Those are completely de-linked concepts and that was the strange aspect, is that by saying from the beginning that you understand that pathogens confer often long-time immunity in a complex way with B cells, T cells, and antibodies to an infection, that should never have been married to the idea that you would want people to let this rip, that you didn't believe in non-pharmaceutical interventions. You didn't believe in masks, distancing, ventilation, hand hygiene, and ways to keep people safe.

I think it got married because of the extreme politics in our country, of which both sides are at fault. As you were intimating, my favorite paper had natural immunities which I will tout to the ends of the Earth because I just couldn't believe how well done it was -- it was this Science paper that was just published in November -- because it had the longest data.

This was Jennifer Dan and colleagues from UCSD, and showing that if you follow these 888 people with COVID-19 with a wide range of severity of illness, some hospitalized, some asymptomatic and mild infection, that you get profoundly robust antibodies, expected, memory B cells that don't even seem to have a half-life.

They just keep on going at the same level, so they're estimating it could be lifelong memory B cells, and then memory T cells that are so high that they emulate the half-life of what happens after a yellow fever vaccination with memory T cells. The yellow fever vaccination is once in a lifetime.

Makary: To our original question, should we be vaccinating people with natural immunity right now? What are your thoughts on that question and why isn't the CDC talking about this?

Gandhi: It could be because immunity to natural infection did become politicized and it could be that it became confusing... we can understand why that became controversial for some of the reasons we talked about before, so it is, they actually did talk about it. The ACIP, when they put out their recommendations on this right after the EUA of the Pfizer vaccine, which was, of course, the first one, it was a week ahead of the Moderna in mid-December. They had in their slide deck that if you have had natural infection you can wait 90 days.

Makary: Yeah. Where did 90 days came from? I saw that. It was almost like a footnote.

Gandhi: Yeah, and it was kind of tiny and it wasn't, like you said, advertised enough. The 90 days came out from as we've been getting the immunity data it's been getting longer and longer and longer by definition because SARS-CoV-2 has been around longer and longer and longer. Some of the first studies said 3 months, you get durable immunity. Just some of the first studies after 3 months. Then they said, "Okay, 90 days. You should wait." They didn't say it strong enough here. They said you can wait, because please give it to other people who need it more.

Then this recent data that's gotten a lot of attention, the Science paper, would suggest you could wait 8 months. It actually could, by the half-life extrapolations, it's suggesting you could wait many years. But at least if we want to be very strict about it, the Science paper went out to 8 months and you have profoundly strong immunity at 8 months after natural infection, very strong from all arms of the immune system, so you could at least wait 8 months.

So the CDC could say, very well grounded in excellent data, that you should wait 8 months. Just let everyone else get it first and then you can wait at least 8 months. They could very well say that on strong scientific data and it would help because people are estimating that at least 14% of the U.S. population and up to 20%... Paul Offit said maybe 20% of the U.S. population has had natural COVID-19 infection, which is not surprising. We've been the epicenter of the pandemic.

That would be a lot of people sitting aside and waiting for other people to have a turn. If we're getting to herd immunity by 70%, if 20% sit aside, then 50% need to get it to get to herd immunity. That makes this whole thing to get back to normal life faster, so I don't know. I would take that data and immediately issue a statement that, "Please wait your turn."

Makary: It's almost like antibody greed. It's like, "I've got 90% immunity, but before you're going to get 60% or any immunity, I want to take that up to 99%." I guess it makes sense if you're an older, at-risk person with kidney failure working in an ICU. That I could have some understanding for, but we're immunizing right now communication staff, accounting staff working from home, spouses of hospital administrators in their 30s and 40s.

We're sort of seeing the true colors of people come out at a time of rationing, which is really where we are. We are rationing. I think your point, though, or the point we're making together here, is very important for everyday practicing physicians that if people come up and ask you, "I've had the infection" -- confirmed, not one of these people, "I think I had it," which is half of America, and they may not have had it because a lot of the viruses circulate. If people have had it for sure, they've been confirmed to have the positive COVID test or the antibodies, they should step aside in the vaccine line in order for us to save the most number of lives.

Gandhi: They should step aside.

Makary: Yeah.

Gandhi: I think you're -- it is, especially healthcare workers, because the reason we've been working since the beginning of the pandemic and we don't have routine testing -- as you know, we work with masks, distancing, ventilation, but without weekly testing, for example, routinely is because we have committed to help others. That is kind of what you do from the very beginning of being a healthcare worker. It would behoove a healthcare worker, that was your point, and you're a young healthcare worker, to make that comment that, "I knew I had COVID. I actually got swabbed. It was back 6 months ago. I know Jennifer Dan says 8 months, so I'm going to wait."

Makary: Monica Gandhi, great to be with you. Great insights. Thanks so much for being with us.

Gandhi: Thank you so much.

https://www.medpagetoday.com/infectiousdisease/covid19/90894

TALEN gene editing tool more efficient than CRISPR-Cas9 in compact DNA: study

 CRISPR-Cas9 has made waves in the biomedical world as a revolutionary gene editing tool, even garnering a 2020 Nobel Prize in chemistry. But it has its limitations.

A research team from the University of Illinois at Urbana-Champaign (UIUC) showed that another gene editing technique called TALEN is up to five times more efficient than CRISPR-Cas9 in a highly compact form of DNA called heterochromatin, according to results published in Nature Communications.

The findings point to TALEN as a better option for the engineering of some hard-to-edit genomic regions, which could be applicable to both research and therapies, the scientists argued. Genetic defects in heterochromatin can cause such diseases as sickle cell anemia, beta thalassemia and fragile X syndrome.

In the CRISPR system, a tailored, single-guide RNA carries DNA-cutting enzymes such as Cas9 to target sites. TALEN also scans DNA to find and target specific genes. Molecules called transcription activator-like effectors, or TALEs, are fused with the DNA scissors, Fok1. On TALE, the highly variable amino acid positions called repeat variable diresidues, or RVDs, act as guides that can recognize specific nucleotides for binding.

But scientists don’t fully understand how TALEs and CRISPR-Cas9 navigate the complex environment of the cell nucleus and search for their target sites in living beings.

For the new study, the UIUC scientists used single-molecule fluorescence microscopy to observe the search dynamics of TALE and a Cas9 mutant. The fluorescent molecule allowed them to measure the time CRISPR and TALEN took to get to their target sites.

The Cas9 protein spent more time than TALE did on both nonspecific sites and local search, the team found. In heterochromatin, both TALE and Cas9 appeared to encounter a considerably constricted search space, the team found. But in at least at one highly compact heterochromatin located in chromosome 16, TALE demonstrated significantly faster search dynamics compared to Cas9.

To evaluate the functional implications of the different search behaviors, the team constructed a series of TALENs and Cas9 guide RNA variants to see how they would edit DNA sequences in highly repressed heterochromatin regions. In 11 out of 12 loci, TALENs showed similar or higher editing activity compared with Cas9.

In some cases, TALENs were over five times more efficient in editing than Cas9-gRNA, the team found.


TALEN is one of several alternate gene editing technologies under development. A Columbia University team used a “jumping gene,” or transposone, from a bacterium called Vibrio cholerae to insert DNA sequences at targeted locations, for example. That system doesn't require the double-strand break that TALEN and CRISPR-Cas9 editing use.

Findings from the UIUC study suggest multiple gene editing tools may be needed, the scientists argued. For one thing, Cas9 appeared to be better at editing in euchromatin sites, the team found. Euchromatin is the most transcriptionally active portion of the genome within the cell nucleus. The researchers proposed that Cas9’s enhanced local search ability is beneficial in a less hindered environment but counteractive in more compact regions.

“Overall, these results serve as a guide in selecting genome-editing proteins for the engineering of hard-to-edit heterochromatin regions of mammalian cells for general as well as therapeutic purposes,” the researchers wrote in the study.

https://www.fiercebiotech.com/research/talen-gene-editing-tool-more-efficient-than-crispr-cas9-certain-dna-study

German Government Told Not to Use AstraZeneca Vaccine for Elderly

 AstraZeneca PLC's vaccine shouldn't be given to people over the age of 64 due to a lack of data about its efficacy in this group, advisers to the German government warned on Thursday, further complicating Europe's stalled Covid-19 vaccine rollout.

The warning, a day before the European Union's medicines agency is expected to recommend use of the company's vaccine, comes as vaccinations are slowing across the region amid a shortage of doses that is threatening plans by European nations to immunize a large part of their populations by the summer.

In the latest setback for the bloc, the European Commission, the EU's executive body, has been sparring with AstraZeneca over the company's announcement last week that it may only be able to deliver as few as 30 million of the 80 million doses it pledged in the first quarter of 2021 due to manufacturing problems at a contractor's plant in Belgium.

The Commission has since accused the British-Swedish company of shipping doses made in the EU to the U.K. It has said it would ask drugmakers to notify authorities before exporting doses out of the EU. On Thursday, an EU official told reporters that they would introduce new criteria allowing national governments to block such exports.

AstraZeneca said it hasn't diverted any European supply to countries outside the EU.

Europe was counting on the AstraZeneca shot to relieve a shortage of vaccines in a region that is registering some of the world's highest daily rates of deaths and new cases. Increasingly, European officials are worried the shot will do little to ease those woes.

The continent is already lagging behind the U.K. and the U.S., which have vaccinated 11.3% and 7.1% of their populations respectively, according to data from Oxford University. By comparison, the EU has vaccinated just 2.2 % of its 450 million people.

One reason for the delays was a temporary cut in vaccine deliveries by Pfizer Inc. and BioNTech SE, makers of the first vaccine to be approved in the region, because of an upgrade to the U.S. company's plant in Belgium. But the European Commission, which centralizes vaccine procurement for the EU, also signed its purchasing contracts later than the U.S. and the U.K. and has generally taken longer to authorize shots.

The standing vaccination committee of Germany's Robert Koch Institute for infectious diseases said in an advisory note to the government leaked on Thursday that the AstraZeneca vaccine should be given only to people aged 18 to 64.

Germany is currently vaccinating people over 80, as well as nursing home residents and staff and medical workers who have close contact with highly vulnerable patients. The country has only vaccinated some two million people since Dec. 28, less than half the 5.7 million people over 80 in the country, and many vaccination centers have stopped giving appointments or reduced their opening hours due to the shortage of vaccine.

A spokeswoman for the RKI confirmed the content of the leak but refused to comment on it. The guidance will be officially published on Friday, when the European Medicines Agency is expected to rule on the AstraZeneca vaccine.

The German government would have to make a formal decision on withholding the vaccine from people over 65 once it is approved by the EU. In this case, it would likely give the shot to medical workers and people aged 60 to 65. People aged 60 and over make up more than a quarter of Germany's 83 million inhabitants, according to government data.

"Given the shortage of vaccines, we have at least 10 hard weeks ahead of us," Health Minister Jens Spahn wrote in a tweet on Thursday.

German Chancellor Angela Merkel said this week every adult in the country who wants a vaccine would be able to get one by the end of the summer as long as manufacturers delivered on their promises. Two thirds of the doses the Commission said it had ordered are for vaccines that have yet to be approved, which for some is only expected to happen late in the year.

The AstraZeneca vaccine, which is already in use in Britain, was developed together with Oxford University, but human trial data documenting the vaccine's efficacy in people 65 and older has been sparse so far, according to independent experts.

In December, peer-reviewed efficacy results published in the Lancet medical journal showed the vaccine to be safe and effective, but independent researchers said not enough trial results in the elderly were available to draw statistically significant conclusions. The University of Oxford and AstraZeneca said at the time they expected more data to become available as trials progressed. They said elderly volunteers were enrolled later in the trials as a safety measure.

AstraZeneca executives argued that the vaccine had already proven safe in the elderly, and that countries need to vaccinate all age groups, from adolescence to the oldest adults, to dent the pandemic globally.

Since Tuesday, the EU's drug regulator has been holding discussions over whether to recommend the vaccine for use in the bloc's 27 countries. The agency has said that given the scale of the pandemic, it would be willing to approve a vaccine that showed even modest effectiveness in preventing Covid-19.

But the agency is also worried about the skepticism towards a vaccine and has asked drugmakers to make sure that at least 7,500 test subjects in their clinical trials were older than 65, or had serious health issues. AstraZeneca has struggled to recruit elderly volunteers and present data on whether the vaccine was effective in those groups.

Italy planned to vaccinate 45% of its population in the first half of the year, starting with medical workers, nursing home staff and residents and those aged 80 and older. Now it says delays in vaccine deliveries could push these plans back by four weeks to eight weeks depending on the age group.

Spain is sticking to its goal of vaccinating 70% of the population by this summer and said on Thursday it was confident manufacturers could recoup the current delays, something experts see as optimistic.

"It's very hard to set goals when there are variables that you can't control, like the regular delivery of the vaccines by the pharmaceutical companies," said Amós García, a Spanish epidemiologist and president of the Spanish Association of Vaccinology.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/German-Government-Told-Not-to-Use-AstraZeneca-Vaccine-for-Elderly-32301818/

EU requests inspection of AstraZeneca vaccine production in Belgium

The European Commission has asked Belgian authorities to inspect production at a plant in Belgium that makes the AstraZeneca coronavirus vaccine, where problems have led to a large shortfall in supply.

Belgium's Federal Agency for Medicines and Health Products (FAGG) said on Thursday that the EU executive, which has coordinated vaccine orders for the European Union, had requested an inspection of production flows. The European Commission declined to comment.

In an emailed response to a question, FAGG said the inspection had not yet taken place, and that it would involve other production sites and authorities in other countries. It did not specify the reason for the inspection.

The European Commission declined to comment.

The EU was stunned a week ago by news that Anglo-Swedish AstraZeneca was cutting its deliveries of doses to the bloc by around 60% in the first quarter. The vaccine is expected to be approved for use on Friday.

AstraZeneca CEO Pascal Soriot said the EU had been late to strike a supply contract, so the company had not had enough time to iron out production problems at a vaccine factory run by a partner in Belgium.

FAGG had already carried out a routine inspection of the site and also reviewed a planned capacity extension at the request of the European Commission earlier this month.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/AstraZeneca-EU-requests-inspection-of-AstraZeneca-vaccine-production-in-Belgium-32301793/

COVID-19 deaths in NY nursing homes 50% higher than claimed: probe

 Gov. Andrew Cuomo’s Health Department understated the number of New Yorkers who died in nursing homes during the early days of the coronavirus pandemic by more than 50 percent as the facilities struggled to properly isolate and treat residents amid a state order they not turn away COVID-19 patients.

The bombshell finding was contained in a new 76-page report released Thursday by state Attorney General Letitia James, which found that mismanagement and long-standing problems in the private care business turned nursing homes into COVID death traps.

“As the pandemic and our investigations continue, it is imperative that we understand
why the residents of nursing homes in New York unnecessarily suffered at such an
alarming rate,” said Attorney General James in a statement.

“While we cannot bring back the individuals we lost to this crisis, this report seeks to offer transparency that the public deserves and to spur increased action to protect our most vulnerable residents,” she continued. “Nursing homes residents and workers deserve to live and work in safe environments, and I will continue to work hard to safeguard this basic right during this precarious time.”

Lawmakers and nursing home advocates alike have been critical of the Cuomo administration’s virus-related policies governing nursing home protocols, specifically a now-infamous March 25 order that barred homes from turning away COVID-positive individuals.

Lawmakers and nursing home advocates alike have been critical of the Cuomo administration’s virus-related policies governing nursing home protocols.
Pacific Press/LightRocket via Ge

As part of the report, James’ investigators surveyed 62 nursing homes across the state and found that 1,914 residents from those facilities either died there or at nearby hospitals after testing positive for coronavirus or exhibiting symptoms of the deadly disease.

That figure was 56 percent higher than the numbers for those facilities published by the state Department of Health, which only published the number of people who passed away while still at the nursing homes at the time of their deaths, not those who were subsequently taken to a hospital and then died.

If that undercount is consistent across the entire state — it would push the number of nursing home deaths from the current tally of 8,711 presumed and confirmed coronavirus cases to more than 13,000.

A patient is loaded into the back of an ambulance by emergency medical workers outside Cobble Hill Health Center, in Brooklyn, New York.
A patient is loaded into the back of an ambulance by emergency medical workers outside Cobble Hill Health Center, in Brooklyn, New York.
AP/John Minchillo

The new report does not increase the number of overall deaths in the Empire State from the coronavirus, which stands at an estimated 42,887 confirmed and suspected COVID-19 cases, according to Johns Hopkins University case tracker.

State DOH puts the number at 34,579, but that tally only includes confirmed deaths.

James’s report shows that nursing homes were even deadlier than previously thought — potentially accounting for nearly one-in-every-three coronavirus fatalities in the state.

It report also revealed that many nursing homes mishandled patients sick with the disease by failing to properly isolate residents who tested positive for COVID-19.

And, it says that nursing home managers often failed to screen and test employees for the virus, demanding that sick staff continue to care for residents or face punishment or termination.

https://nypost.com/2021/01/28/ny-nursing-home-covid-deaths-50-higher-than-stated-ag-probe/

Zymeworks investors wake up to competition

 At a time when the Her2-positive breast cancer space is celebrating the approval of not one but four new drugs in the past year, any future rival had better differentiate itself. And this is what Zymeworks failed to do yesterday in a convoluted update on its contender ZW49.

To be clear, ZW49 is not Zymeworks’ lead; that honour belongs to another Her2-directed asset, zanidatamab, a bispecific the group reckons could displace Roche’s Herceptin and Perjeta in the front-line setting. But with so much uncertainty around both assets Zymeworks’ stock cooled off 25% overnight.

Zanidatamab is still some way from the market in breast cancer, and its more likely initial use is biliary tract cancer, with filing expected next year. As such, the update of a phase I study of ZW49, an anti-Her2 antibody-drug conjugate, in various tumours was a big focal point for analysts.

Two remissions... and tox

The upshot of yesterday’s after-market update, which Stifel analysts described as messy and confusing, was that six subjects in phase I dose escalation are evaluable for efficacy, and two of these have reported partial remissions. While this concerned several Her2-positive tumours, the company did not split these out.

It is likely that more mature data, expected in the second half, will be needed to quantify how competitive ZW49’s efficacy is, but Pfizer’s rival developmental anti-Her2 ADC, PF-06804103, has yielded a 39% ORR, for example.

Perhaps more concerning was Zymeworks’ disclosure of keratitis as an adverse event, though this does not appear to be as serious as the ocular toxicity that led to a boxed warning on the label of Glaxosmithkline’s Blenrep. But as keratitis is known to be associated with other ADCs it could make differentiation harder still for ZW49.

The next stage is to progress with three expansion cohorts, which comprise Her2-high breast cancer, Her2-high gastroesophageal adenocarcinoma, and other Her2-positive cancers.

While breast cancer clearly is not the only opportunity it is the most important one. Around 15% of breast and gastric cancers alike are thought to be Her2-high, but Her2-low tumours account for two thirds of the former versus just a quarter of the latter cancer type. Zymeworks argues that current front-line treatments largely cannot address Her2-low patients, but that its more sophisticated Her2-targeting projects can.

Still, Her2-positive breast cancer also happens to have the most competition. Roche has a stranglehold on perioperative, first and second-line settings, and there are four second/third-line Her2-directed newcomers: Puma’s Nerlynx, which also hits Her4 and EGFR, Seagen’s Tukysa, Macrogenics’ Margenza and, most importantly, Astrazeneca/Daiichi’s Enhertu.

Selected treatments and projects for Her2-positive breast cancer
NameModalityCompanyStatus
HerceptinMAbRoche (and biosimilars)Approved neoadjuvant, adjuvant & 1st-line
PerjetaMAbRocheApproved neoadjuvant, adjuvant & 1st-line
NerlynxSmall moleculePumaApproved extended adjuvant & 3rd-line
KadcylaADCRocheApproved 2nd-line
TukysaSmall moleculeSeagenApproved 2nd-line + Herceptin
TykerbSmall moleculeNovartisApproved 3rd-line
MargenzaFc-optimised MAbMacrogenicsApproved 3rd-line
EnhertuADCAstrazeneca/DaiichiApproved 3rd-line
ZanidatamabDual epitope bispecificZymeworks/Beigene40% ORR in BTC (n=20), 39% ORR in GEA (n=33)
ZW49ADCZymeworks/Beigene33% ORR in various cancers (n=6)
PF-06804103ADCPfizer39% ORR in various cancers (n=31)
PRS-343BispecificPieris12% ORR in various cancers (n=33); on clinical hold until 19 Jan
ADC=antibody-drug conjugate; BTC=biliary tract cancer; GEA=gastroesophageal adenocarcinoma. Source: product labels & meeting presentations.

Meanwhile, Zymeworks’ lead asset, zanidatamab, a bispecific hitting two different Her2 epitopes, also has its work cut out.

Pivotal biliary tract and gastroesophageal cancer trials read out in 2022 and 2023 respectively, but in breast cancer it is still early days, with mid-stage studies comprising an Ibrance combination in ER-positive patients and a front-line chemo combo.

The latter might give clues as to how zanidatamab might square up first-line against Herceptin or Perjeta, but as neither Roche drug is available in this trial, which is being run in South Korea and Taiwan, this seems to have little relevance to lucrative western markets.

It is admirable for Zymeworks to aim to displace Herceptin and Perjeta as the foundation of Her2-positive breast cancer treatment, but before it can run it must first learn to walk.

https://www.evaluate.com/vantage/articles/news/trial-results/zymeworks-investors-wake-competition

Docs call on Biden to include medical groups in COVID-19 vaccine distribution

 Medical practices are largely being left out of the COVID-19 vaccine efforts, a survey from the Medical Group Management Association (MGMA) found. 

The survey, which reflected responses from 403 medical group practices, showed 85% of independent practices actively seeking the COVID-19 vaccine for their patients received some as of Jan. 21-24. Nearly half (45%) of hospital- or health system-owned practices seeking vaccines still hadn't gotten any. 

Meanwhile, the majority of practices that have gotten the vaccine (54%) say they only received enough to vaccinate 1% or less of their patients.

MGMA sent a letter Tuesday calling on the Biden administration to include medical group practices in COVID-19 vaccine distribution strategies moving forward.

“Current distribution efforts take patients away from trusted ties with their physicians and force them into haphazard vaccine chasing," said Halee Fischer-Wright, M.D., president and CEO of MGMA, in a statement. "Physician practices have the capacity and strategic ability to proactively deliver the vaccine by identifying patients by age, preexisting conditions, and other risk factors. Patients trust their physicians to answer questions about vaccine safety and efficacy. MGMA calls on the new Administration to leverage the nation’s medical groups to expedite and streamline the vaccine rollout. Without physicians at the helm of this critical effort, patients will be left behind."