Fauci ‘cautiously optimistic’ development of COVID-19 vaccine could happen by the beginning of 2021 – SBS News

Fauci ‘cautiously optimistic’ development of COVID-19 vaccine could happen by the beginning of 2021 – SBS News

BD to manufacture injection devices for Covid-19 vaccination in US – Medical Device Network

BD to manufacture injection devices for Covid-19 vaccination in US – Medical Device Network

July 9, 2020

]]> BD will deliver 50 million needles and syringes by the end of this year to support the Covid-19 vaccination effort in the US. Credit: BD.

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Becton, Dickinson and Company (BD) has formed a strategic partnership with the Biomedical Advanced Research and Development Authority (BARDA) in the US to establish new manufacturing lines for injection devices.

BARDA is part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response.

The companys additional manufacturing lines will provide the US Government with priority access to huge volumes of syringes and needles to support its ongoing and future pandemic vaccination efforts.

As part of the partnership, BARDA will invest an estimated $42m into a $70m capital project to expand BDs operations and manufacturing capacity in Nebraska within 12 months.

Once completed, BARDA will have priority access to injection devices from the new manufacturing lines to support mass vaccination efforts for Covid-19 and future pandemics in the US.

In addition, BD also finalised an initial pandemic order for 50 million needles and syringes to be delivered by the end of this year to support the countrys Covid-19 vaccination effort.

The order will be fulfilled using the companys existing manufacturing capacity. BD noted the initial order will not affect the ability to fulfil existing customer requirements for needles and syringes.

BD Medication Delivery Solutions president Rick Byrd said: BDs commitment to produce 50 million vaccine injection devices by the end of this year to support the US Covid-19 vaccination campaign is the latest effort in the companys multifaceted global response to this virus, and the new, strategic public-private partnership will help ensure the US is prepared for future pandemic vaccination efforts.

We are extremely proud of our talented and dedicated workforce in Nebraska and our longstanding partnership with the state, and we look forward to building on our strong presence and track record in Nebraska as we move forward.

Meanwhile, BD is also working to expand access to diagnostic testing and support treatment of Covid-19 patients in the US.

The company has supplied approximately 48 million swabs for flu and Covid-19 testing and over 2.85 million Covid-19 rapid molecular diagnostic tests on the BD MAX System globally.


See more here: BD to manufacture injection devices for Covid-19 vaccination in US - Medical Device Network
How a coronavirus vaccine will get to market – PBS NewsHour

How a coronavirus vaccine will get to market – PBS NewsHour

July 9, 2020

With new daily case counts of novel coronavirus on the rise in nearly every state, as well as Puerto Rico, the consequences of reopening much of the country without first stopping the spread has made one thing clear: An unlocked United States will likely continue to suffer from the deadly virus until a safe and efficient vaccine is finally distributed to a majority of the population.

There are lots of different ways to formulate a vaccine, and all of them are now being considered for coronavirus. Some vaccines use common methods to confer immunity, while others are entirely experimental theyve never before been approved for use.

No matter the approach, academic, corporate and government research teams around the globe are coordinating with national and international agencies to move their candidates through preclinical animal trials and, for those with promising results, human trials. All of them aim to one day see millions, even billions, of doses of their vaccine manufactured and distributed to those in need hopefully, sooner rather than later.

But leading public health officials like Dr. Anthony Fauci have warned there is simply no guarantee that the ongoing national research effort will produce a successful vaccine in 12 to 18 months a timetable hes repeatedly laid out.

Dr. Anthony Fauci has warned there is no guarantee that the ongoing national research effort will produce a successful vaccine in 12 to 18 months.

In testimony last week, Fauci, one of the leading members of the White Houses coronavirus task force, emphasized the unpredictable nature of vaccine development, while adding that hes hopeful that a number of doses will be approved and available for distribution by the beginning of 2021.

We are cautiously optimistic, looking at animal data and the early preliminary data, that we will at least know the extent of efficacy [for vaccines that go through clinical trials] sometime in the winter and early part of next year, he said before the Senate Committee on Health, Education, Labor, and Pensions.

Vaccines normally go through around a decade of research and evaluation before finally being approved for commercial use. But public health officials have determined that the urgency of the pandemic demands a significantly expedited version of that process.

With any potential vaccine, researchers have to ask a series of questions: Does it successfully prompt a desired immune response in humans? Has it been shown to be both safe and effective? Can manufacturing be scaled up to meet the demand required by this crisis?

More dilemmas are likely to arise once a vaccine has been approved for use, one of the most crucial being which groups will be first to receive it, and how that decision will be made.

Heres a look at some of the top vaccine contenders, as well as the challenges public health officials will face when that vaccine is finally ready for use.

One of our immune systems main attributes is that it can remember what viruses look like so that our cells know how to fight them off if they infect us again. When weve been vaccinated against a pathogen or exposed to it naturally, we usually suffer less severe symptoms, or none at all.

In the case of coronavirus, which is believed to have just recently evolved to infect humans, its not yet clear if, or for how long, a person who has survived COVID-19 is protected against reinfection. More conclusive antibody research is needed to determine whether those who have already had the virus will need a vaccine, or if those who do get the vaccine will eventually need booster shots as maintenance.

Megan McGrew/PBS NewsHour

Under normal circumstances, candidate vaccines first go through preclinical trials in which animals like mice or monkeys are inoculated. Researchers then evaluate whether their bodies produced an immune response that would potentially protect against infection in humans, and look for any adverse side effects.

After that, successful candidates are eligible to be tested in humans. During the first phase of clinical trials, researchers give the vaccine to a small number of healthy adults to check for safety and immunogenicity, or the vaccines ability to prompt its desired immune response. The second phase of this effort, which involves several hundred volunteers, looks for any unwanted side effects and determines what dose produces the most effective immune response.

The third and final phase of vaccine testing continues to evaluate safety and effectiveness by inoculating thousands, even tens of thousands, of volunteers and determines how well the vaccine prevents infection while noting any rare side effects associated with it that didnt become apparent during earlier phases.

If all of these steps are successfully completed, researchers can submit their data for review by the Food and Drug Administrations Center for Biologics Evaluation and Research. That division is responsible for approving vaccines, overseeing their production and continuing to monitor them once theyre on the market. Only about 6 percent of candidate vaccines are ever approved for commercial use.

Only about 6 percent of candidate vaccines are ever approved for commercial use.

To identify a promising vaccine for coronavirus, researchers are instead evaluating all of these factors safety, immunogenicity, efficacy, side effects in parallel through trials that combine the phases of a typical vaccine development process.

During last weeks hearing, FDA Commissioner Stephen Hahn emphasized the importance of including racial minorities, the elderly, pregnant women and those with other health conditions in large scale human trials to ensure that any vaccine moving through the approval process will be effective on populations most vulnerable to COVID-19. Pregnant people and the elderly or immunocompromised typically arent involved in trials like this, but have been identified as being at greater risk for severe virus outcomes, so researchers must ensure these vaccines protect them.

The Defense Department, one of the agencies partnering on the Trump administrations national vaccine development initiative, has said that officials expect to be producing large quantities of vaccines while the clinical trials are still underway, so that there is no delay in manufacturing once safety and efficacy have been demonstrated.

Operation Warp Speed is aiming to deliver 300 million doses of a safe, effective vaccine by January 2021, according to the Department of Health and Human Services. In order to do that, billions of federal dollars are being allocated to scale up manufacturing of a handful of promising candidates before theyre actually authorized for distribution. Its a financial risk that most private companies would be loath to take, but a necessary gamble for the government in the context of the pandemic.

Among the 21 global candidate vaccines currently moving through clinical trials, Operation Warp Speed has begun to single out a handful of contenders by offering them funding, including AstraZeneca, Moderna and Novavax and Johnson & Johnson. The criteria for how those companies were chosen is not fully clear, a concern that lawmakers have pointed out and pushed Trump administration officials for answers. Heres what we do know:

AstraZeneca: The vaccine, developed by researchers at the University of Oxford, is a modified adenovirus that mimics the new coronavirus spike proteins, which are what allows the virus to invade human cells. When introduced to the human body, the vaccine aims to prompt the creation of antibodies that would neutralize the actual coronavirus and prevent it from entering an infected persons cells. Phase 3 trials recently kicked off in Britain, Brazil and South Africa.

WATCH: Meet people volunteering to be exposed to COVID-19 for vaccine research

Last month, AstraZeneca announced that it had reached an agreement with the Coalition for Epidemic Preparedness Innovations and Gavi The Vaccine Alliance to support the manufacturing, procurement and distribution of 300 million doses of its vaccine, and that delivery would start by the end of this year. The company also said that it would partner with the Serum Institute of India to supply one billion doses for low and middle-income countries, with a commitment to provide 400 million before the end of 2020.

Moderna: This candidate vaccine injects messenger RNA into the body that cells then translate into antigens resembling the coronavirus spike proteins, which intend to prompt the creation of antibodies that would neutralize the new coronavirus if a vaccinated person were to be infected.

Vaccines that use messenger RNA to provide immunity have never been approved for human use, but several are being tested to protect against COVID-19. If Modernas makes it to the finish line, itll be the first of its class to do so. A phase 3 study involving 30,000 volunteers is set to begin this month, and Moderna has partnered with the Swiss pharmaceutical company Lonza to manufacture approximately 500 million, but potentially up to 1 billion, doses per year.

Part of the appeal of Modernas vaccine is that messenger RNA is easy to make and not very stable it disintegrates quickly in the body, which means its fairly safe. But that quality could also make an mRNA vaccine difficult to distribute widely. mRNA needs to be stored at around negative 80 degrees Centigrade a much lower temperature than most other vaccines which infectious disease expert Paul Offit pointed out would be difficult to accommodate in many settings.

Novavax: The biotechnology company announced this week that Operation Warp Speed had pledged $1.6 billion to support late-stage clinical testing of the companys candidate vaccine, which is currently moving through a combined Phase 1/2 clinical trial. Novavax expects to see preliminary results regarding the vaccines safety and immunogenicity by the end of the month.

According to Novavax, its vaccine combines recombinant nanoparticle technology to create an antigen derived from the coronavirus spike protein with an adjuvant, or a compound that enhances the bodys immune response.

Johnson & Johnson: Johnson & Johnsons candidate vaccine combines genetic material from the coronavirus with a modified adenovirus in order to prompt a protective immune response, according to CNBC News.

In June, Johnson & Johnson announced that it expects a combined Phase 1/2a clinical trial of its vaccine involving over 1,000 healthy adults to begin in the U.S. and Belgium later this month. The company said that the trial will evaluate safety, immunogenicity and reactogenicity, or response to vaccination, and that its currently in discussions with the National Institutes of Allergy and Infectious Diseases to start a Phase 3 trial, pending the outcome of Phase 1 studies and the approval of regulators.

Dr. Soumya Swaminathan, chief scientist at the World Health Organization, recently identified AstraZenecas vaccine as the leading candidate of the vaccines currently undergoing clinical evaluation. She added that Modernas vaccine is not too far behind, and that at least four Chinese companies are preparing to kick off large scale Phase 3 trials for their candidates one of which was recently approved for military use in China.

While those two candidates appear to be among the top contenders, a lot could change between now and the end of this year, let alone by the end of 2021, in the search for a viable coronavirus vaccine.

Experts also warn that the first vaccines may not be effective in completely preventing COVID-19 infection.

The chair of the United Kingdoms vaccine taskforce, Kate Bingham, has said she expects that the first coronavirus vaccines to prove safe and effective may help alleviate the symptoms of COVID-19, rather than conferring full immunity, The Guardian reported last week.

Thats a prediction echoed by Offit, who explained that early vaccines will aim to reduce a persons likelihood of developing moderate to severe disease, but might not protect against reinfection or mild symptoms associated with coronavirus.

The goal of this vaccine is going to be to keep you out of the hospital and keep you out of the morgue, Offit said.

In order to restore a degree of normalcy to U.S. lives without constant fear of a resurgence, Fauci has said that between 70 to 85 percent of the population will need to be immunized against coronavirus. That will grant the nation herd immunity, which occurs when a large enough portion of a population is immune to a disease that they indirectly protect those who are not immune.

Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, estimates that between 5 to 8 percent of the U.S. population has been infected with coronavirus so far. He emphasized during last weeks Senate hearing that it would take several years to achieve herd immunity through natural exposure, hence the urgent need for an effective vaccine.

The goal of this vaccine is going to be to keep you out of the hospital and keep you out of the morgue.

For many countries, financial challenges may make it difficult to afford the millions or even billions of doses needed to vaccinate their populations. Vaccines need to be kept at a strict temperature range to remain effective, which could make mass distribution a challenge in many parts of the globe given the volume of doses that this crisis demands.

Lois Privor-Dumm, director of policy, advocacy and communications at the Johns Hopkins Bloomberg School of Public Healths International Vaccine Access Center, said that the moral question of who to vaccinate first is a difficult one, but that most agree that health care workers are very high priority due to their increased risk of exposure.

She emphasized that we must also consider how to make the vaccine available to undocumented people, low-income people, those experiencing homelessness, and other populations that often struggle with health care access. People in these situations, she noted, can be the same ones doing essential work in their communities, putting themselves at greater risk of infection.

Another challenge will be ensuring that vaccines are effective in seniors, whose immune systems generally dont respond as efficiently to immunization. Offit said that it will therefore be important to immunize people who frequently interact with elders, such as home health workers and nursing home staff.

Maria Elena Bottazzi, associate dean at the Baylor College of Medicines National School of Tropical Medicine and co-director of Texas Childrens Center for Vaccine Development, said that any vaccine thats approved for use will have to meet a series of major requirements. It must induce the correct immune response, and have the best safety profile possible. In order to be distributed widely, it will need to be capable of being manufactured at large scales.

She also noted that after a vaccine is developed and brought to market, there are always second [and] third generation iterations that seek to improve upon the original.

Once an initial vaccine is launched and licensed, theres a lot of what we call postmarketing surveillance, which eventually leads to better vaccines, Bottazzi explained. Continuing to monitor a vaccine can also reveal any rare negative side effects.

Due to cost and manufacturing limitations, she envisions a toolbox of initial vaccines, some of which are more accessible to a wide range of nations, while others may only be available in wealthier countries.

Multiple lawmakers have raised concerns about the affordability and availability of an eventual vaccine. Sen. Bernie Sanders pointed out in last weeks hearing with leading health officials that billions of taxpayer dollars are funding pharmaceutical companies in their effort to develop a vaccine. He asked, given the significant of that investment, if every person in the country can expect to have access to an eventual vaccine regardless of their income.

All four public health officials present during the hearing Fauci, Redfield, Hahn, Redfield and Assistant Secretary for Health Adm. Brett Giroir answered Sanders question affirmatively.

Once a vaccine is finally approved, manufactured and available for widespread distribution, the question then becomes whether individuals and families want to be inoculated. A recent poll from The Associated Press and the NORC Center for Public Affairs research found that just 49 percent of people in the U.S. plan to actually get an eventual COVID-19 vaccine.

The poll also found that 40 percent of Black people and 23 percent of Hispanic people dont intend to get vaccinated at all. In the case of the Black community, that stance may be in part rooted in general mistrust of the medical establishment. Black Americans have long suffered from lack of access to quality medical care, and even outright abuse at the hands of researchers.

But in the context of the pandemic, those numbers are troubling, given that Black and Hispanic individuals, in addition to Native people, are four to five times more likely to be hospitalized due to COVID-19 infection. The Centers for Disease Control and Prevention states that long-standing systemic health and social inequities are responsible for putting marginalized people at an increased risk of experiencing severe illness due to the virus, regardless of age.

Megan McGrew/PBS NewsHour

During his testimony on Tuesday, Fauci pointed to a community engagement arm of Operation Warp Speed, echoing the concern that a substantial portion of the population, particularly those most at risk for serious disease, will be unwilling to receive the vaccine. He emphasized the need for trusted figures to engage with their communities and help spread accurate information regarding the importance of vaccination, citing the role that kind of outreach played in mitigating the AIDS crisis.

We used people in the community boots on the ground to go out, who looked and lived and are like the people theyre trying to engage, Fauci said, adding that such local engagement is critical to build the trust that will ultimately save lives.

So, while a coronavirus vaccine is still months possibly years away, public health officials know that the time now to start building the publics confidence.


Read more:
How a coronavirus vaccine will get to market - PBS NewsHour
U.S. Weighs Early Vaccine Access for Minorities and Others at Risk – The New York Times

U.S. Weighs Early Vaccine Access for Minorities and Others at Risk – The New York Times

July 9, 2020

Its racial inequality inequality in housing, inequality in employment, inequality in access to health care that produced the underlying diseases, Dr. Matthew said in an interview. Thats wrong. And its that inequality that requires us to prioritize by race and ethnicity.

Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania, is not a member of the committee, but has been suggesting other ways vaccine prioritization could work. He predicts that courts would strike down any guidelines explicitly based on race and ethnicity. Instead, he has proposed using an index that takes into account education, income, employment and housing quality to rank neighborhoods by socioeconomic disadvantage that he says could serve as a good proxy.

Its imperative that we pay attention to how Covid has impacted the health of minorities differently; otherwise it compounds the inequalities weve seen, Dr. Schmidt said.

There may be substantial differences in how racial and ethnic groups view vaccines. A recent Pew survey found that a little over half of Black adults said they would definitely or probably get a coronavirus vaccine if one were available today, while 44 percent said they would not. Among Hispanic and white adults, 74 percent said they would get the vaccine, while around a quarter said they would not.

Because of Tuskegee and structural racism within the health care system, you have to make a case much more strongly to the African-American population, Dr. Schmidt said.

Whoever is prioritized for the first doses, it will not matter if the vaccines dont work for those demographics. And that will not be determined unless the vaccine trials themselves include those groups. So far, several vaccine candidates have entered final Phase 3 trials.

At a Senate hearing last week, Dr. Robert R. Redfield, the C.D.C. director, and Dr. Francis Collins, head of the National Institutes for Health, emphasized the need for racial and other diversity within the trials.


Originally posted here:
U.S. Weighs Early Vaccine Access for Minorities and Others at Risk - The New York Times
Could a coronavirus vaccine rehab the pharmaceutical industry’s reputation despite drug price increases? – USA TODAY

Could a coronavirus vaccine rehab the pharmaceutical industry’s reputation despite drug price increases? – USA TODAY

July 9, 2020

Dr. Francis Collins, Director of the U.S. National Institutes of Health said Thursday that "we are all optimistic" that the Trump administration's vaccine-acceleration program will produce a safe and effective vaccine for COVID-19 by year end. (July 2) AP Domestic

For years, the pharmaceutical industry has faced withering bipartisan criticism and a deteriorating reputation among the publicfor its role in driving up drug prices.

But the sector suddenly might be poised to go from villain to hero with the development of a vaccine that could end the COVID-19 pandemic.

The drug industry's reputation started this crisis in the basement afterhavingplunged toan all-time low in 2019, making it the least popular sector among 25 major industries, according to pollster Gallup.

Americans soured on the industry after net drug priceswhich factor in rebates and discounts increased by 60% from 2007 to 2018, about triple the rate of inflation, according to a University of Pittsburgh study. High-profile examples of sharp drug price hikes in recent years have included "Pharma Bro" Martin Shkreli's 5,000% increase of a life-saving treatment Daraprim and Mylan's about six-fold increase of the EpiPen, an emergency allergic reaction treatment.

While drugmakers throughout the world are chasing a coronavirus vaccine and only a few, at most, can win, the feverish pursuitrepresents one of the greatest opportunities in the history of medicinewith the reputational benefits alone worth the effort, not to mention the financial possibilities. The companies pursuing a vaccine include giants like Pfizer, Moderna, Johnson & Johnson, AstraZeneca, Merck and GlaxoSmithKline.

Drug companies have "spared no expense to kind of pivot and shift" to tackle the coronavirus, Gilead Sciences CEO Daniel O'Day told investors on a conference call April 30. "I think this will certainly help the industry's reputation."

Hundreds of pharmaceutical companies are pursuing a vaccine for COVID-19.(Photo: Getty Images)

Yet there are also potholes on the road to a vaccine for the drug industry, as Americans and industry critics express concern that the race could help pharma companies justify price increases and avoid a regulatory crackdown.

With drug prices where theyre at, people cant afford them and they are dying, saidTim Lash, chief strategy officer of West Health, a nonprofit that pursues lower health care costs. He added thatthere is very real concern about pharma leveraging the coronavirus vaccine push to increase the price of other treatments.

The chance to developa vaccine or a successful treatmentthat could save millions of lives and jobshas attracted hundreds of playersdespite the high likelihood of failure for most of them.

Vaccines which save about 2.5 million lives annually from conditions such as polio, measles and diphtheriarepresent "one of the most successful and cost-effective health interventions" ever, according to the World Health Organization.

Potential COVID-19treatments under development include150 vaccine candidates, 160 novel medications designed to kill the virus and 300 existing drugs that could be repurposed to treat it, according to the Biotechnology Innovation Organization (BIO), a trade group that represents biotech companies.

What experts say: We're one-third of the way to a widely available coronavirus vaccine

The race for a vaccine: FDA says a coronavirus vaccine would have to be at least 50% effective to be approved

Anthony Fauci, director of the U.S. government'sNational Institute of Allergy and Infectious Diseases, recently predicted that a vaccine could arrive by the end of 2020 or early 2021.

Pharma industry executives say the vaccine push shows how the industry is committed to using profits, which havebeen the target of much criticism, to support their pursuit of life-saving medications. About 90% of drug candidates fail,illustrating the need for substantial investments in potential therapies,saidStephen Ubl, CEO of industry trade group PhRMA, which represents pharmaceutical companies on policy issues in Washington,

"The coronavirus gives us the opportunity to tell the real story of the importance of the industry and why a robust biopharmaceutical sector is absolutely critical to the public health," Ubl said.

The pandemic has driven the public eye onto what the biotech industry does, which is change the dynamic of a disease, said Jeremy Levin, chairman of BIO and author of the recently published book Biotechnology in the Time of COVID-19: Commentaries from the Front Line.

But industry critics say pharmaceutical companies shouldn't be let off the hook for their role in driving up drug prices.

"There are certainly bright spots in the pharma sector in terms of innovation, hope and optimism and certainly those three things would apply to the work thats happening around COVID-19," Lash said. "But if you look at the performance of Big Pharma and their behavior over the last decade, it paints a very dark picture of drug pricing in America."

A study conducted byWest Health and polling outfit Gallup found that in a given 12-month period, about 1 in 5 American adults are unable to pay at least once for needed prescribed drugs.

And nearly 9 in 10 Americans are concerned that pharmaceutical companies will raise drug prices to compensate for the coronavirus vaccine race, according to another study by West Health and Gallup.

"The pharmaceutical sector has historically leveragedprice increases to further maximize profit," Lash said.

Pharmaceutical executives say their pricing is justified due to the high cost of research and developmentthat is now contributing to the pursuit of a vaccine for the coronavirus.

In this March 2020 photo provided by Gilead Sciences, a vial of the investigational drug remdesivir is visually inspected at a Gilead manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material.(Photo: AP)

For example, Gilead Sciences recently won approval to distribute its remdesivir drug as a treatment for critically ill COVID-19 patients. That antiviral drug, which Gilead said it spent more than $1 billion to develop,originally came about during thepursuit of a remedy for Ebola several years ago but went nowhere at the time. Gilead on June 29announced a pricing plan: $3,120 per treatment course for the typical insured patient.

It's currently unclear how a potential vaccine would be priced or whether it would be covered by insurance or by the government. The federal government's Operation Warp Speed is providing nearly $10 billion in funds to aid in the development and production of various coronavirus vaccines with a goal of delivering 300 million dosesby January 2021.

The average private-sector non-influenza vaccine for adults ranges from about $26for Grifols' tetanus and diphtheria toxoids inoculation to $228for Merck's Human papillomavirus inoculation, according to the CDC.

Ubl said Americans don't need to be concerned about the price of a COVID-19 vaccine. "The industry is deeply committed to, when we find safe and effective therapies, we want them to be safe and accessible," he said.

He attributed much of the criticism over drug prices to "relatively few bad actors" responsible for sharp increases, including Shkreli, who was later imprisoned after being convicted on unrelated fraud charges, and Mylan.

In the noise that came from the bad actors, we basically lost sight of the essence of what the biotech is all about, which is patients and innovation, Levin said

With the public's attention suddenly focused on the push for a vaccine, the pharmaceutical industry senses an opportunity to ease regulatorypressure in Washington, too.

The pressure has come in the rare form of abipartisan chorus, ranging as widely as President Donald Trump to one of his fiercest critics, Sen. Bernie Sanders (D-Vermont), both of whomhave repeatedly called for policies to restrict drug prices.

Bernie Sanders.(Photo: Timothy A. Clary/Getty Images)

Some say thefederal government's Medicare program should be allowed to negotiate drug prices instead of paying market value, a move that advocates say would help lower prices across the board. Others say the government should impose caps on drug prices, among other possibilities.

Ubl criticized the push for "draconian policies that would upend the business model" and "throw sand into the gears" of innovation. But he said he's hopeful that policymakers will recognize that the race to solve the coronavirus pandemic "highlights the benefit of our free market system."

PhRMA has led a marketing and publicity campaign in recent months to promote the industry's role in developing a vaccine or treatment. The group has advertised in news outlet Politico's influential "Playbook" e-newsletter, run a print advertisement along with BIO, published blog posts, compiledfact sheets andwritten reports documenting the industry's commitment to developing a safe and effective vaccine expeditiously.

Gilead CEO O'Day said in the April 30 call that he had already noticed a shift in rhetoric about drug pricing on Capitol Hill following the emergence of the pandemic.

"I think people are very appreciative and concerned about finding solutions here. And it's brought us all together, which I think is a good thing," he said. "I'm not suggesting that there won't continue to be focus and pressure on drug pricing. Of course, there will be. ... But it's being done now in a way where we can have an appreciation for the innovation the industry brings."

Lash said policymakers should not fall for the suggestion that pharmaceutical companies have taken an altruistic turn.

The pharmaceutical industry cant escape the fact that its the most profitable sector in our economy when you look at return on investment capital, he said.

For their part, Americans have placed significant blame on pharmaceutical companies for drug prices.

Only 21% of Americans gave the pharmaceutical sector positive ratings in a 2019 Gallup survey, while 58% gave it negative ratings. The industry'sreputation was even worse than the federal government's.

Its hard to do worse than the government in these types of positivity, negativity ratings, said Dan Witters, research director of theGallupNational Health and Well-Being Index. Theres real public sentiment here against pharmaceutical companies.

Witters conceded that the COVID-19 vaccine race could lend some buoyancy to the industrys reputation.

But in the long run, Americans are unlikely to forgive the industry for drug prices, he said.

In my opinion, whatever goodwill may ultimately be bought for the pharmaceutical industry as a function for its efforts to come up with a vaccine, I think its going to be fleeting, Witters said. The concern about rising costs generally is overwhelming.

Follow USA TODAY reporter Nathan Bomey on Twitter @NathanBomey.

Read or Share this story: https://www.usatoday.com/story/money/2020/07/08/coronavirus-vaccine-covid-19-pharmaceutical-industry/5354630002/


View post: Could a coronavirus vaccine rehab the pharmaceutical industry's reputation despite drug price increases? - USA TODAY
COVID-19 Daily Update 7-8-2020 – 5 PM – West Virginia Department of Health and Human Resources

COVID-19 Daily Update 7-8-2020 – 5 PM – West Virginia Department of Health and Human Resources

July 9, 2020

TheWest Virginia Department of Health and Human Resources (DHHR)reports as of 5:00 p.m., on July 8, 2020, there have been 193,810 total confirmatory laboratory results receivedfor COVID-19, with 3,707 total cases and 95 deaths.

In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.

CASESPER COUNTY (Case confirmed by lab test/Probable case):Barbour(17/0), Berkeley (490/18), Boone (27/0), Braxton (3/0), Brooke (14/1), Cabell(178/6), Calhoun (4/0), Clay (11/0), Fayette (78/0), Gilmer (13/0), Grant(15/1), Greenbrier (67/0), Hampshire (42/0), Hancock (31/3), Hardy (45/1),Harrison (91/0), Jackson (148/0), Jefferson (244/5), Kanawha (366/10), Lewis(19/1), Lincoln (10/0), Logan (30/0), Marion (92/3), Marshall (48/1), Mason(21/0), McDowell (6/0), Mercer (59/0), Mineral (59/2), Mingo (24/2), Monongalia(381/14), Monroe (14/1), Morgan (19/1), Nicholas (14/1), Ohio (113/0),Pendleton (13/1), Pleasants (4/1), Pocahontas (36/1), Preston (75/16), Putnam(74/1), Raleigh (64/1), Randolph (170/2), Ritchie (2/0), Roane (11/0), Summers(2/0), Taylor (18/1), Tucker (6/0), Tyler (7/0), Upshur (21/1), Wayne (119/1),Webster (1/0), Wetzel (25/0), Wirt (5/0), Wood (149/8), Wyoming (7/0).

As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.Such is the case Boone, Jefferson, Morgan, and Wyoming counties in this report.

Please visit thedashboard at www.coronavirus.wv.gov for more detailed information.


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COVID-19 Daily Update 7-8-2020 - 5 PM - West Virginia Department of Health and Human Resources
COVID-19 Daily Update 7-8-2020 – 10 AM – West Virginia Department of Health and Human Resources

COVID-19 Daily Update 7-8-2020 – 10 AM – West Virginia Department of Health and Human Resources

July 9, 2020

TheWest Virginia Department of Health and Human Resources (DHHR)reports as of 10:00 a.m., on July 8, 2020, there have been 192,849 totalconfirmatory laboratory results receivedfor COVID-19, with 3,615 total cases and 95 deaths.

In alignment with updated definitions fromthe Centers for Disease Control and Prevention, the dashboard includes probablecases which are individuals that have symptoms and either serologic (antibody)or epidemiologic (e.g., a link to a confirmed case) evidence of disease, but noconfirmatory test.

CASES PER COUNTY (Caseconfirmed by lab test/Probable case): Barbour(17/0), Berkeley (483/18), Boone (28/0), Braxton (3/0), Brooke (14/1), Cabell(167/6), Calhoun (4/0), Clay (11/0), Fayette (76/0), Gilmer (13/0), Grant (15/1),Greenbrier (67/0), Hampshire (42/0), Hancock (30/3), Hardy (44/1), Harrison(85/0), Jackson (146/0), Jefferson (245/5), Kanawha (354/10), Lewis (19/1),Lincoln (9/0), Logan (30/0), Marion (91/3), Marshall (46/1), Mason (21/0),McDowell (6/0), Mercer (58/0), Mineral (58/2), Mingo (20/2), Monongalia(354/14), Monroe (14/1), Morgan (20/1), Nicholas (14/1), Ohio (112/1),Pendleton (13/1), Pleasants (4/1), Pocahontas (36/1), Preston (74/16), Putnam(71/1), Raleigh (63/1), Randolph (169/2), Ritchie (2/0), Roane (11/0), Summers(2/0), Taylor (18/1), Tucker (6/0), Tyler (6/0), Upshur (21/1), Wayne (119/1),Webster (1/0), Wetzel (25/0), Wirt (5/0), Wood (139/8), Wyoming (8/0).

As case surveillance continues at thelocal health department level, it may reveal that those tested in a certaincounty may not be a resident of that county, or even the state as an individualin question may have crossed the state border to be tested.Such is the case of Raleigh County in this report.

Please visit thedashboard at www.coronavirus.wv.gov for more information.


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COVID-19 Daily Update 7-8-2020 - 10 AM - West Virginia Department of Health and Human Resources
Max Minute: A Realistic Look At How Long It Will Take To Develop Coronavirus Vaccine – CBS New York

Max Minute: A Realistic Look At How Long It Will Take To Develop Coronavirus Vaccine – CBS New York

July 9, 2020

NEW YORK (CBSNewYork) As the coronavirus pandemic rages on, many are putting their hopes on a vaccine to end the health crisis.

But how long will it really take for one to become available and how long will it last in your system? CBS2s Dr. Max Gomez has more in his latest Max Minute report.

As the COVID-19 pandemic continues to spread unabated across much of the country, the nation holds on to the hope that a vaccine is what will finally allow us to begin a return to whatever normal will be.

But is that hope and the promised delivery timeline realistic?

While there are as many as 100 candidate vaccines in development around the world, there are perhaps a half-dozen outside of China that have begun actual human testing. The final Phase 3 is by far the most time consuming, normally requiring years and tens of thousands of volunteers to test a vaccine for effectiveness and especially for safety because vaccines can actually make a disease much worse.

Then theres the question of how long a vaccines immunity will last.

If you look at the neutralizing antibody from recovered patient, as Dr. Fauci said, it only lasts three-to-six months, so thats very short duration, said Dr. Henry Ji, CEO of Sorrento Therapeutics.

MORE:Max Minute: World Health Organization Says Small Airborne Particles Can Infect People With COVID-19

Sorrento is one of the companies with a vaccine in development. Others have announced positive test results in either Phase 2 or 3 human trials. What none of the companies have announced is whether they will attempt human challenge trials in Phase 3, where volunteers will be deliberately infected with coronavirus. That is the only way to speed up vaccine testing.

Without human challenge trials, Phase 3 vaccine testing usually takes years, making the often cited end-of-the-year vaccine availability wildly optimistic in the view of many impartial experts. So, for now, please wear a mask and practice social distancing.

For the top questions people have been asking about the coronavirus, visitcbsnewyork.com/max, and go tofacebook.com/cbsnewyorkto submit your question.


Excerpt from: Max Minute: A Realistic Look At How Long It Will Take To Develop Coronavirus Vaccine - CBS New York
Even without a Covid-19 vaccine, there’s reason for hope – CNN

Even without a Covid-19 vaccine, there’s reason for hope – CNN

July 9, 2020

Vaccines don't act as impenetrable shields that prevent viruses from entering our bodies. Rather, they teach our bodies how to rapidly mobilize our immune defenses against a foreign invader. The rapid immune response helps us clear the virus from the body before it wreaks its damage.


See the rest here: Even without a Covid-19 vaccine, there's reason for hope - CNN
Coronavirus daily news updates, July 8: What to know today about COVID-19 in the Seattle area, Washington state and the world – Seattle Times

Coronavirus daily news updates, July 8: What to know today about COVID-19 in the Seattle area, Washington state and the world – Seattle Times

July 9, 2020

Editors note:This is a live account of COVID-19 updates from Wednesday, July 8, as the day unfolded. It is no longer being updated. Clickhereto see all the most recent news about the pandemic, andclick hereto find additional resources.

As of Tuesday, Washington businesses are required to turn away customers who arent wearing face coverings, per a new statewide order.

The rule comes as the World Health Organization acknowledges that airborne transmission of the virus may be a threat indoors which could have broad implications for our daily lives.

Heres what researchers have found aboutthe most effective non-medical masks, andhow to wear a face mask properly.

Throughout Wednesday, on this page, well be posting Seattle Times journalists updates on the outbreak and its effects on the Seattle area, the Pacific Northwest and the world. Updates from Tuesday can be foundhere, and all our coronavirus coverage can be foundhere.

In the wake of a pandemic that has triggered unpredictable costs for school districts across the country, the Seattle School Board approved $1.3 billion in spending for the upcoming school year at its Wednesday meeting.

The budget passed with four yes votes and three abstentions from Board members Lisa Rivera-Smith, Eden Mack and Leslie Harris. Mack and Harris questioned the accuracy of the budget, given uncertainty about how many students will re-enroll in the fall, and what additional costs may arise from the districts negotiations with its teachers union over reopening schools.

Im rather concerned that we are not set up effectively for the current crisis and what is actually going to happen come fall, Mack said.

District officials said theyre confident they can flex the 2020-21 budget to meet the anticipated costs associated with reopening in the fall, about $15 million. The district will also receive more than $10 million from the federal CARES Act.

Read the full story here.

Dahlia Bazzaz

Wearing a mask and standing against the wall while reporters stood in an awkward configuration 6 to 10 feet apart down T-Mobile Parks club-level hallway, Mariners general manager Jerry Dipoto answered questions about the start of summer camp Wednesday.

The coronavirus has changed just about everything.

On Wednesday, the Mariners released their results from 122 initial intake tests prior to the start of summer camp workouts, and three players tested positive for COVID-19. All three were asymptomatic and are in minimum 14-day quarantine and following the required procedure to be cleared, which includes daily testing. After the 14-day quarantine, a person must test negative on consecutive days before beginning the process to be admitted to workouts.

Dipoto said hes encouraged because other teams have reported more positive tests in the intake period.

Read the full story here.

Ryan Divish

The United States Department of Labor on Wednesday approved a trade adjustment assistance petition filed by hundreds of Alcoa workers trying to save their jobs at the company's Ferndale aluminum smelter.

The petition was filed by the International Association of Machinists and Aerospace Workers (IAMAW) for the more than 700 workers at the Whatcom County plant. It will provide the workers with training and resources to get rehired, according to a statement from Rep. Suzan DelBene's office.

Alcoa announced in April that the plant the last remaining smelter west of the Mississippi would curtail production by July, citing challenges created by the coronavirus crisis. The company also announced it would cut $100 million in capital expenditures and defer $220 million in pension fund contributions.

In May, DelBene and Sen. Patty Murray, joined by Sen. Maria Cantwell and Rep. Rick Larsen, wrote a letter to the U.S. Secretary of Labor Eugene Scalia to support the petition, according to the statement.

These layoffs could not have come at a worse time amid a global pandemic," DelBene said in the statement. "The transition for the workers at the Intalco facility wont be easy but the TAA assistance approved today is a critical resource for them and their families during this difficult time."

The four lawmakers also wrote to the president and CEO of the Alcoa Corporation, as well as to President Donald Trump, urging him to "prioritize resolving the issue of excess Chinese aluminum capacity, which has depressed prices in the global market and harmed American businesses and workers, specifically in Washington state."

Elise Takahama and Geoff Baker

Public Health Seattle & King County shut down Dukes Seafood on Alki Beach on Wednesday morning as a safety precaution after seven employees at the popular West Seattle hangout tested positive for thecoronavirusin the past two weeks, management confirmed.

A source told The Seattle Times that two employees at its branches in Bellevue and Tacoma also tested positive, though neither of those restaurants was shut down.

Dukes management released a statement Wednesday saying team members at three locations alerted us to exposure to COVID-19 outside of the restaurant over the past few weeks. Each subsequently tested positive. When we learned of their exposures, we worked to contain it, evaluated each situation, informed all company team members, alerted the health department, and notified our guests through a variety of channels. In each case, we closed these stores for cleaning and to allow time for team members to be tested.

Read the full story here.

Tan Vinh

Washington Athletics performed coronavirus tests on 17 athletes who returned to campus this week and those tests revealed zero positive cases, according to a university release.

In four weeks of testing, 157 Husky athletes have been tested and there have been three positive tests (1.9%). Of those three positive tests, just one is an active positive case. That unnamed individual is currently going through UWs COVID-19 care and quarantine protocols.

Additionally, the release stated that surveillance testing is being done on athletes who have previously returned to campus, and those tests have returned zero positive cases as well.

The university declines to name the athletes who tested positive or provide details on which sports they participate in.

Read the full story here.

Mike Vorel

This year's Washington State Fair which has run mostly uninterrupted for about 120 years has been canceled due to coronavirus concerns, the fair said in a statement Wednesday.

"We have met the challenges of fires and floods, withstood changes in culture and the challenges of time and, except for the four years of World War II, operated uninterrupted that entire span," the statement said. "Now, after thoughtful consideration, we have made the difficult decision to cancel the 2020 Fair."

The decision was made by the fair's board of directors, which voted on the cancellation after reviewing recommendations from the management team. This years fair was supposed to take place in Puyallup in September.

"Though it was a difficult decision, it was really the only decision possible based on what we currently know," the statement said. "It was a decision made in what we feel are the best interests of the health and safety of all of our guests, our employees, our exhibitors."

The fair still plans to host three events this summer, including a drive-thru food-to-go event, a drive-in concert series and a drive-in movie night. More information about each event is available here.

Read the full story here.

Yasmeen Wafai and Elise Takahama

Washington health officials confirmed 521 additional coronavirus cases on Wednesday, including 10 more deaths.

The update brings the states totals to 37,941 cases and 1,394 deaths, meaning about 3.7% of people diagnosed in Washington have died,according to the state Department of Health (DOH). The data is as of 11:59 p.m. Tuesday.

So far, 645,072 tests for the novel coronavirus have been conducted in the state, per DOH. Of those, 5.9% have come back positive since testing began.

Overall deaths are concentrated in King County, Washington's most populous county, where DOH has confirmed 11,284 diagnoses and 628 deaths accounting for about 45% of the state's death toll.

Elise Takahama

SPRINGFIELD TOWNSHIP, N.J. Armed with a cheap steak knife and a plastic basket lined with a garbage bag, a high-school sophomore named Alicia Garlic sat cross-legged in the dirt at Specca Farms, a pick-your-own operation here in South Jersey.

Garlic wasnt picking greens for herself on this Tuesday morning in June, but for Farmers Against Hunger, a program of the New Jersey Agricultural Society. Along with more than a dozen others spread out along the rows for social distancing a retired schoolteacher, a Census Bureau employee, a young mother with her grade-schooler in tow she was there to glean, a practice traditionally defined as gathering anything left over after a harvest.

Then came the coronavirus pandemic, mile-long traffic jams at food banks and the disturbing sight of farmers plowing under their onions when food-service contracts disappeared overnight.

Now, gleaning groups are at the front lines of those helping to stabilize the nations shaky food supply, perfectly positioned to leverage one problem a bounty of unsellable crops to help solve another: rampant hunger.

The New York Times

In late May, former World Bank president Jim Yong Kim, an American who has served in Democratic and Republican administrations, waxed incredulous at the lack of a coordinated U.S. strategy aimed at combating the novel coronavirus.

The thing thats been driving me crazy is that weve just decided that the standard health response the only thing thats worked in any of the countries that suppressed the virus is something that were just not going to do, Kim said.

Sara Cody, head of the public health department in Californias Santa Clara County, known now for orchestrating one of the countrys earliest coronavirus shutdowns, was also on the call. She seemed relieved to hear him say so.

Cody is not alone among U.S. health officials, epidemiologists, virologists and other experts in feeling like she missed the memo saying the worlds richest nation really couldnt do much to keep this virus from paralyzing it. Many local officials are still asking the same question Kim posed that day: Why have we given up on containment?

So far, that political will has been largely lacking, from President Donald Trump down to many state and local officials trying to limit the viruss spread without destroying the economy.

The Washington Post

The Ivy League on Wednesday became the first Division I conference to say it will not play sports this fall because of the coronavirus pandemic, a person with knowledge of the decision told The Associated Press. The league left open the possibility of moving some seasons to the spring if the outbreak is better controlled by then.

Although the coalition of eight academically elite schools does not grant athletic scholarships or compete for an NCAA football championship, the move could have ripple effects throughout the big business of college sports. Football players in the Power Five conferences have already begun workouts for a season that starts on Aug. 29, even as their schools weigh whether to open their campuses to students or continue classes remotely.

The Ivy decision affects not just football but everything before Jan. 1, including soccer, field hockey, volleyball and cross country, as well as the nonconference portion of the basketball season.

Power Five conferences told The Associated Press on Wednesday that they were still considering their options. But it was the Ivy Leagues March 10 decision to scuttle its postseason basketball tournament that preceded a cascade of cancellations that eventually enveloped all major college and professional sports.

Associated Press

A new report studying the impact of the coronavirus on workers at meat processing plants has found that 87% of people infected were racial or ethnic minorities and that at least 86 workers have died.

The report released Tuesday by the U.S. Centers for Disease Control and Prevention examined more than 16,000 COVID-19 cases at 239 plants in 21 states. It offers perspective on how the virus devastated U.S. pork, beef and poultry processing plants, but the figures likely understate the problem as Iowa officials declined to participate in the study.

Iowa is the nations largest pork-producing state and saw severe coronavirus outbreaks at several huge processing plants.

The CDC report found 87% of coronavirus cases occurred among racial and ethnic minorities even though they made up 61% of the overall worker population. The data shows 56% of coronavirus illnesses involved Hispanic workers, 19% were non-Hispanic Blacks and 12% were Asians. The data showed 13% of coronavirus cases involved white workers, who made up 39% of the overall workforce studied.

Read the full story here.

The Associated Press

President Donald Trumps campaign rally in Tulsa that drew thousands of people in late June, along with large protests that accompanied it, likely contributed to a dramatic surge in new coronavirus cases, Tulsa City-County Health Department Director Dr. Bruce Dart said Wednesday.

Tulsa County reported 261 confirmed new cases on Monday, a one-day record high, and another 206 cases on Tuesday.

Although the health departments policy is to not publicly identify individual settings where people may have contracted the virus, Dart said those large gatherings more than likely contributed to the spike.

In the past few days, weve seen almost 500 new cases, and we had several large events just over two weeks ago, so I guess we just connect the dots, Dart said.

A spokesman for the Trump campaign didnt immediately respond to a request for comment.

Read the full story here.

The Associated Press

The Centers for Disease Control and Prevention will issue new guidance on school openings, Vice President Mike Pence said on Wednesday, hours after President Donald Trump criticized earlier recommendations as very impractical and vowed to meet with the agency himself.

Citing Trumps concern that the guidance might be too tough, Pence said the CDC would issue additional recommendations starting next week that would provide more clarity and stressed that the guidelines should not supplant judgments by local officials.

We dont want the guidance from CDC to be a reason why schools dont open, Pence said. I think that every American, every American knows that we can safely reopen our schools. . . . We want, as the president said this morning, to make sure that what were doing doesnt stand in the way of doing that.

His comments, at a White House coronavirus task force briefing, came about two hours after Trump undercut the recommendations of administration health experts as he continued to ramp up pressure on state and local officials to reopen schools this fall.

Read the full story here.

The Washington Post

United Airlines is warning 36,000 employees nearly half its U.S. staff they could be furloughed in October, the clearest signal yet of how deeply the virus pandemic is hurting the airline industry.

The outlook for a recovery in air travel has dimmed in just the past two weeks, as infection rates rise in much of the U.S. and some states impose new quarantine requirements on travelers.

United officials said Wednesday that they still hope to limit the number of layoffs by offering early retirement benefits, and that 36,000 is a worst-case scenario. The notices going to employees this month are meant to comply with a 60-day warning ahead of mass job cuts.

The furloughs could include up to 15,000 flight attendants, 11,000 customer service and gate agents, 5,500 maintenance workers and 2,250 pilots.

Read the full story here.

The Associated Press

TOKYO Japan is facing a sudden spike in coronavirus cases, but this time with no political will for another round of economically punishing shutdowns.

At the end of last month, the national government abruptly dismantled a panel of medical experts that had been guiding the response to the virus, and replaced it with a group that includes envoys from the business world and others.

Tokyos municipal government also abandoned an alert system based on numerical targets that could have triggered fresh shutdowns if the virus started spreading again.

The message from Japans leadership has been clear: The virus will be tackled only through measures that would not further harm the economy, according to Tokyos governor, Yuriko Koike.

Read the full story here.

The Washington Post

ATLANTA Atlantas mayor says she will sign an executive order mandating masks in Georgias largest city Wednesday, defying Gov. Brian Kemps decision to strongly encourage but not require face coverings.

Spokesman Michael Smith said Mayor Keisha Lance Bottoms plans to sign an order requiring masks, which could set up a confrontation with the Republican Kemp.

Like a number of other local leaders in Georgia, Bottoms has unsuccessfully appealed to Kemp to change his order that local governments cant exceed the states requirements.

Read the full story here.

The Associated Press

Missouri leaders knew the risk of convening thousands of kids at summer camps across the state during a pandemic, the states top health official said, and insisted that camp organizers have plans in place to keep an outbreak from happening.


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Coronavirus daily news updates, July 8: What to know today about COVID-19 in the Seattle area, Washington state and the world - Seattle Times
Explained: Doubts over herd immunity – The Indian Express

Explained: Doubts over herd immunity – The Indian Express

July 9, 2020

Written by Kaunain Sheriff M | New Delhi | Updated: July 9, 2020 8:09:15 am People throng a market at lower Bazar, Shimla on June 25, 2020. (Express Photo: Pradeep Kumar)

A new study published in The Lancet has concluded that herd immunity against Covid-19 is difficult to achieve at this stage, while a separate commentary describes it as unachievable. The conclusion is based on estimates of seroprevalence for the entire Spanish population.

Herd immunity refers to a situation when a certain percentage of the population have become immune to a certain disease-causing pathogen, thus preventing the infection from spreading to the rest of the population. While the concept is most commonly used in the context of vaccination, herd community can also be reached when enough people have become immune after being infected.

The premise is that if a certain percentage is immune, members of that group can no longer infect another person. This breaks the chain of infection through the community (herd) and prevents it from reaching those who are the most vulnerable.

What is the new study?

It is a large-scale seroepidemiological study, and concluded that just five per cent of the Spanish population has developed antibodies in response to SARS-CoV-2, the virus that causes Covid-19. This implies that an estimated 95 per cent continues to be susceptible to the virus.

The study, which included 66,805 participants, was conducted between April 27 and May 11. It found that seroprevalence for the entire country was 5% by the point-of-care test and 4.6% by immunoassay. In seven provinces in the central part of Spain, including Madrid, seroprevalence was greater than 10 percent; and in provinces along the coast, seroprevalence was greater than 5% only in Barcelona.

In age-specific findings, according to the point-of-care test, seroprevalence was 1.1 percent in infants younger than 1 year and 3.1 percent in children aged 5-9 years, increasing with age until plateauing around 6 percent in people aged 45 years or older.

How significant is the study?

It is the largest serological study conducted so far in Europe and captures the true number of Covid-19 infections, which isnt captured by laboratory tests. It provides an estimate for the population of the entire country. Based on an overall seroprevalence range of 3.7% to 6.2% and accounting for the proportions of seropositive individuals who were asymptomatic, the study estimated that between 3,76,000 and 10,42,000 asymptomatic individuals went undetected in the non-institutionalised Spanish population.

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What are the implications of the study?

While a seroprevalence study largely provides information only about previous exposure to the virus, this study strengthens the line of argument that in the absence of treatment or a vaccine against Covid-19, achieving herd immunity at this stage is not possible.

Herd immunity is difficult to achieve without accepting the collateral damage of many deaths in the susceptible population and overburdening of health systems, it states.

In a separate commentary on the study, German virologists Isabella Eckerle and Benjamin Meyr wrote in The Lancet: In light of these findings, any proposed approach to achieve herd immunity through natural infection is not only highly unethical but also unachievable. With a large majority of the population being infection naive, virus circulation can quickly return to early pandemic dimensions in a second wave once measures are lifted.

Beyond Spain, the study sends signals to other countries: that even in countries that have reported high prevalence of Covid-19, the pandemic is far from coming to an end; therefore, these countries have to be cautious about easing of restrictions.

Why does the study suggest that herd immunity is difficult?

At the beginning of the pandemic, the United Kingdom had hinted at a strategy that would allow the novel coronavirus to infect 60 per cent of the countrys population so that a degree of herd immunity could be achieved.

Now, the data from Spain shows that in a country that has reported community transmission, only an estimated 5% have developed antibodies in response to the virus. Hence the conclusion.

In their commentary, the German virologists have raised two important issues: At present, immunity after SARS-CoV-2 infection is thought to be incomplete and temporary, lasting only several months to a few years; second, it is unknown whether these patients are protected by other immune functions, such as cellular immunity.

What have previous seroprevalence studies revealed?

On June 11, The Lancet published a paper by researchers who had studied seroprevalence of anti-SARS-CoV-2 antibodies in 2,766 participants in Geneva. They estimated seroprevalence of 4.8% in the first week, 8.5% in the second week, 10.9% in the third week, 6.6% in the fourth week and 10.8% in the fifth week. After accounting for the time to seroconversion, we estimated that for every reported confirmed case, there were 11.6 infections in the community, the researchers wrote.

On June 5, Nature published a study conducted by researchers from China, who studied seroprevalence of specific antibodies immunoglobulin M and G against SARS-CoV-2 in 17,368 individuals from Wuhan, the epicentre of the pandemic in the country. The study found that seropositivity varied between 3.2% and 3.8% in different sub-cohorts. It also found that patients who visited hospitals for dialysis, and healthcare workers had a higher seroprevalence 3.3% and that seropositivity progressively decreased in other cities as the distance of the epicenter increased.

Dont miss from Explained | Could the Covid-19 virus be airborne?

On May 18, a research letter published in the Journal of the Medical Association said that the prevalence of antibodies to SARS-CoV-2 was found to be 4.65% in a community seroprevalence study conducted in Los Angeles County. The study tested 865 participants on April 10. The researchers estimated that approximately 3.67 lakh adults had SARS-CoV-2 antibodies which is substantially greater than the 8,430 cumulative number of confirmed infections in the county on April 10. Therefore, fatality rates based on confirmed cases may be higher than rates based on the number of infections, the study said.

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Explained: Doubts over herd immunity - The Indian Express