Category: Covid-19 Vaccine

BioNTech SE (BNTX) and Pfizer (PFE), Moderna (MRNA), and AstraZeneca (AZN) and Oxford are leaders in the race for US approval of a vaccine for COVID-19. I feel PFE/BNTX is likely to be the first to report a result from a 30,000-patient US trial, the minimum size of trial the FDA has asked for in order to warrant emergency use authorisation. A look at the potential timelines and progress is nonetheless warranted.

PFE/BNTX's BNT162b2, an RNA vaccine which codes for "an optimized SARS-CoV-2 full-length spike glycoprotein(s)," was selected over BNT162b1 based on the results of an earlier clinical study. BNT162b1 will still be tested by BNTX and Fosun Pharma in China. The PFE/BNTX phase 2/3 study of BNT162b2 consists of two doses, separated by 21 days. PFE and BNTX announced the start of this study on July 27, it contains up to 30,000 participants and includes regions where there is "significant expected SARS-CoV-2 transmission." Looking in such regions is of value as a higher event rate (proportion of those developing COVID-19) will help detect a difference between placebo and BNT162b2.

By August 20, three weeks and three days after initiation, PFE disclosed it had enrolled 11,000 participants in the 30,000-participant study. A second dosing was already underway (which makes sense as the second dose occurs at 21 days). Despite the already rapid enrolment at the time of the August 20 press release, additional trial sites were being opened in Turkey, Germany, and South Africa. By August 26, a PFE scientist reported that the study was now over 50% enrolled (>15,000 participants). PFE/BNTX plans to submit for approval in October if the phase 2/3 study is successful. PFE begins looking at COVID-19 cases to compare the control and vaccine just seven days after the second dose.

Figure 1: Select primary outcome measures from PFE/BNTX's phase 2/3 study. Source: Clinicaltrials.gov.

Now, let's look at MRNA. MRNA announced the 30,000-participant, phase 3 COVE study of mRNA-1273 on July 27. By August 21, MRNA had enrolled 13,194 participants. Enrolment in MRNA's trial was apparently 8,374 in three weeks according to CNN on August 18. That is quite an increase in the rate of enrolment from August 18 to August 21, unless the 8,374 number came from earlier in the third week, rather than the end of the third week. Unfortunately, the CNN article noted concerns MRNA wasn't enrolling enough minorities.

While Black people and Latinos account for more than 50% of Covid-19 cases nationwide, so far they make up only about 15% of participants in the nation's first large-scale clinical trial to test out a coronavirus vaccine, according to data obtained by CNN from a government official.

CNN article by Elizabeth Cohen, August 18, 2020.

With the August 21 update from MRNA came an update with some details on minorities in MRNA's trial.

As of Friday, August 21, Black or African American, Latinx, American Indian and Alaska Native participants make up approximately 18% of all participants in the Phase 3 study.

MRNA COVE study website.

The CNN article discussed the possibility of the COVE study having to slow enrolment to make sure more minorities were being recruited. As such, MRNA is at risk of falling behind PFE/BNTX.

A similar update came on August 28 when the company noted enrolment was now at 17,458. It looks like MRNA has been successful at increasing the proportion of minorities in the trial.

Figure 2: Enrolment trends by week in MRNA's COVE study. The orange proportion represents the percentage of white participants, not the proportion has fallen week to week as enrolment grows, MRNA making efforts to make sure that the trial population is more representative of those impacted by COVID-19 outside of the trial. MRNA COVE study website.

When we consider the trial design of MRNA's COVE study, we see it creates delays in reporting a result relative to the design of the PFE/BNTX study. The COVE study doses patients on day 1 and day 29 and looks at the occurrence of COVID-19 at 14 days after the second dose and onwards. Since PFE is dosing patients on day 1 and day 21 and looking at COVID-19 cases from day 7 and onwards after the second dose, PFE has a two-week advantage over MRNA. Those tracking the rate of enrolment in MRNA's study note that enrolment is proceeding at about 4,000 participants per week and should be complete in the third week of September. Given that PFE seems to be enrolling patients at a similar rate, it seems likely that the two-week advantage should be enough for PFE/BNTX to report results before MRNA.

Figure 3: Primary outcomes of the COVE study. Source: Clinicaltrials.gov.

For AZN/Oxford, there was a discussion that if the company's 10,000-patient UK study demonstrates their vaccine (AZD1222) is effective, that emergency use authorisation is possible, despite the FDA having asked for studies in at least 30,000 people. Since AZN pretty strongly played down these suggestions, it isn't really clear if the name is really the front-runner, which leads me back to PFE and BioNTech. For example, on August 31, AZN announced it was planning to enroll more than 50,000 participants, including 30,000 in the US. It is possible, however, that data from the other 20,000 participants is announced prior to data from the 30,000 US patients being announced.

For clarity, the 30,000-patient US study is currently listed as "Not yet recruiting" although it was reported September 1 the trial was now enrolling. That trial doses patients twice, four weeks apart and looks at COVID-19 cases at 15 days and onward after the second dose.

Regarding the ex-US studies, the UK study is enrolling at 20 sites and has a targeted enrolment of 12,330 patients. That study does involve repeat dosing of the candidate COVID-19 vaccine four to six weeks apart in some arms of the study but doesn't specify when following dosing a look at COVID-19 cases compared to the control will be performed. The UK trial also includes an active comparator arm of two doses of a meningococcal vaccine, given 4-12 weeks apart. That could slow down any readout from the trial substantially. Further, a comparison of the ex-US studies shows some inconsistencies in the protocol. For example, there are differences in the second dose used in the UK and South African trials. Meanwhile, the Brazilian trial in 5,000 participants is only using a single dose.

It is worth mentioning that AZN has a 1,090-patient phase 1/2 study that could demonstrate efficacy but perhaps the confidence interval on that efficacy would be wider than the FDA wants (the lower bound would span below 30% efficacy; the FDA wants 50% efficacy with a lower bound above 30%). That trial won't be enough for approval anywhere in the world then but could signal that developing an effective COVID-19 vaccine is possible.

PFE/BNTX appear to be about two weeks ahead of MRNA in terms of timelines to report a result, due to the tighter dosing schedule (21 days vs. 29 days) and timelines for the endpoint (7 days vs. 14 days). Both trials appear to be enrolling at very similar rates. AZN/Oxford appears committed to not cutting any corners and a result in the US is further away. The timing of a result in AZN's ex-US studies seems harder to pin down and investors will need to wait for updates in that case.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Who Is Ahead In The COVID-19 Vaccine Race? - Seeking Alpha

A new report that aims to prioritize groups to receive Covid-19 vaccine focuses on who is at risk, rather than using job categories or ethnic groups to determine who should be at the front of the line.

It was widely expected that health care workers would be the first priority grouping, and some though not all are. There were also many voices arguing for people of color to be given priority access, because the pandemic has exacted a disproportionately heavy toll on Black and Latinx people, both in terms of overall numbers of infections and deaths.

But in the end the panel of experts that wrote the priority setting framework for the National Academies of Sciences, Engineering, and Medicine chose instead to focus on the factors that create the risk for some people of color systemic racism that leads to higher levels of poor health and socioeconomic factors such as working in jobs that cannot be done from home or living in crowded settings. The report, a draft, was issued Tuesday.

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This virus has no sense of skin color. But it can exploit vulnerabilities, said Bill Foege, a former director of the Centers for Disease Control, who is co-chair of the committee. The committee was set up by the National Academies at the request of Francis Collins, director of the National Institutes of Health, and Robert Redfield, director of the Centers for Disease Control and Prevention.

Foege said he expects pushback. A virtual public meeting on the recommendations will be held Wednesday afternoon, and written comments can be submitted until Friday. The committees final report will be submitted later in September.

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When Covid-19 vaccines are approved for use, initial supplies will be tight potentially in the tens of millions of doses. Most of the vaccines under development will require two doses per person: a priming dose followed by a booster either three or four weeks later.

The resulting recommendations put health workers in high risk settings and first responders to the very front of the vaccination line, in what the committee called the jumpstart phase. Closely behind are adults of any age who have medical conditions that put them at significantly higher risk of having severe disease, primarily heart or kidney failure or a body mass index of 40 and over. Also in this group are older adults living in long-term care homes or other crowded settings.

The report suggests that a second phase of vaccinations should involve critical risk workers people in industries essential to the functioning of society as well as teachers and school staff; people of all ages with an underlying health problem that moderately increases the risk of severe Covid-19; all older adults not vaccinated in the first phase; people in homeless shelters and group homes, and prisons; and staff working in these facilities.

Young adults, children, and workers in essential industries not vaccinated previously would make up the third priority group. Remaining Americans who were not vaccinated in the first three groups would be offered vaccine during a fourth and final phase.

The report is meant to serve as a guide for more detailed prioritization plans on the order in which Americans will be offered vaccine. That more granular work is already being conducted by the Advisory Committee on Immunization Practices, an expert panel that crafts vaccination guidance for the CDC, and by state, local, and tribal health authorities, who must identify the actual people in their regions who fall into the priority groups.

The ACIPs recommendations will go to the CDC. It remains unclear, however, whether the CDC, Operation Warp Speed the task force set up to fast-track development of Covid-19 vaccines, drugs, and diagnostics or the White House will make the final determinations on who will be vaccinated first.

The draft report, produced in just a little over a month, earned some early praise.

I think they did a really good job, said Eric Toner of the Johns Hopkins Center for Global Security, calling the report credible and based on sound reasoning.

Toner and colleagues published their own report on the issue recently, recommending two tiers. Health workers and others essential to the Covid-19 response in the first tier and other health workers in the second.

In that report, people at greatest risk and their caregivers, and workers most essential to maintaining core societal functions would also be designated to be in the first tier.

The task of determining who should be at the front of the vaccines line is not an easy one, and must be made without crucial pieces of information. Its not yet known how many vaccines will prove to be successful, when they will be approved for use, and in what quantities. Critically, some vaccines may prove to be more effective in key groups the elderly, for instance than others. Knowing that in advance could influence the recommendations, but people working on the priority groups cannot wait for that information to become available.

Initial discussions suggest, depending on how some of the target groups are defined, large numbers of Americans would qualify as members of priority groups, a reality that will likely require additional tough decisions to be made.

The CDC estimates that there are between 17 million and 20 million health care workers in the country, and roughly 100 million people with medical conditions that put them at increased risk of severe illness if they contract Covid-19. There are roughly 53 million Americans aged 65 and older, and 100 million people in jobs designated as essential services. There is some overlap among these groups health workers, for instance, are also essential workers.

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US advisory group lays out proposal on how to prioritize Covid-19 vaccine - STAT

As COVID-19 vaccines reach final stages, who will be first in line?  NBCNews.com

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As COVID-19 vaccines reach final stages, who will be first in line? - NBCNews.com

Six months into the COVID-19 pandemic in the United States, everyone is looking for hopeful signs that life can return to normal on any level. Encouraging news reports indicate that the race to develop a COVID vaccine is progressing, with hopes that one will receive approval and become commercially available by early in 2021.

With a vaccine comes some difficult questions for employers. Can employers mandate a vaccine as a condition of employment? Even if they can do so legally, should they?

Private employers likely have the legal right to require employees to obtain a COVID vaccine as a condition of employment. For years, many employers in high-risk workplaces (e.g., hospitals and nursing homes) have required their employees to obtain an annual flu vaccine. This does not pose problems in the ordinary course. Given the estimated 180,000 Americans (and counting) who have died from COVID, it seems unlikely that lawmakers will enact legislation that would preclude employers generally from mandating a COVID vaccine.

With that said, employers may also have a legal duty under the Americans with Disabilities Act to allow certain employees to opt out of the vaccine. For example, given the speed with which the vaccine candidates are moving through clinical trials, employees in high-risk categories may receive advice from their health care providers not to receive the vaccine at least initially until the complications are better understood. Alternatively, perhaps young, healthy employees who are at relatively low risk from COVID may obtain notes indicating that the vaccine is not necessary for their own health.

If employees request an accommodation from an employers COVID vaccine mandate, the employer will need to determine whether the accommodation is a reasonable one and whether it imposes an undue burden on operations and on the health and safety of coworkers. As with all ADA accommodation requests, employers will need to carefully consider the facts on a case-by-case basis.

Additionally, employees may object to the vaccine on religious grounds. Again, employers must balance employees right to be free from religious discrimination against the burden that the accommodation would create in the workplace. (Note that the Supreme Court has stated that employers have less obligation to accommodate employees religious objections than their medical needs. In religious discrimination cases, the employer can deny the request if it imposes more than a minimal burden on the business.)

As the legal rules above suggest, implementing a mandatory vaccine program will likely require employers to devote considerable time and energy to the program. In addition to dealing with accommodation requests, employers will need to decide questions such as:

In addition, employers who mandate a vaccine will need to consider the potential liability that arises from doing so. What happens if an employee has a severe reaction to the vaccine and then argues that he would not have gotten the vaccine except that his employer required it? Could the employer be held liable because of the mandatory vaccine policy? Its difficult to say right now, but employers cannot simply ignore this possibility.

Ultimately, this will likely involve risk balancing. For employers that cannot effectively socially distance and those who work with high-risk populations, a mandate probably makes sense to minimize the risk of a COVID outbreak. (For example, imagine a nursing home not requiring a vaccine and then experiencing a spread of COVID through its elderly population. Hindsight being 20/20, it would be easy to say that the employer should have mandated a COVID vaccine.) For other employers, the risks may outweigh the benefits, especially in the first few months after a vaccine is released.

For now, the questions remain hypothetical. Until a vaccine is made available and we have more information about its efficacy and risk factors, it is difficult to answer these questions in a vacuum. Nevertheless, employers ought to start thinking about their proposed approach to COVID vaccinations so that they are ready to implement a plan when the time comes (hopefully in the not-too-distant future).

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Mandatory COVID-19 Vaccines: Coming to a Workplace Near You? - JD Supra

BALTIMORE, Sept. 1, 2020 /PRNewswire/ -- Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development and commercialization of therapies for genetic diseases and vaccines, announced that Fujita Health University has received acontract from the Japan Agency for Medical Research and Development (AMED) to initiate Phase I/II clinical trials of the company's COVID-19 vaccine candidate, EXG-5003. Clinical trials are expected to begin at Fujita Health University Hospital in Aichi, Japan in Q1 2021.

EXG-5003 is a temperature-sensitive self-replicating RNA vaccine expressing the receptor binding domain of the SARS-CoV-2 spike protein. EXG-5003 was optimized for intradermal injection withpotential dose-sparing and safety benefits.

About Elixirgen Therapeutics, Inc.

Elixirgen Therapeutics, Inc. is a Baltimore-based biotechnology company, which is focused on curing humanity's ailments through innovations in gene and cell therapy, including stem cell therapy. Elixirgen Therapeutics, Inc. is now applying its RNA technology to the development of a COVID-19 vaccine.For more information visit http://www.ElixirgenTherapeutics.com

About Fujita Health University

Fujita Health University plays a major role in treating COVID-19 patients and conducting its clinical trials in Japan. For more information visit http://www.fujita-hu.ac.jp/en/

Forward-Looking Statements

This press release may contain "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine and our planned clinical relationship with Fujita Health University. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development. Any forward-looking statements in this press release speak only as of the date of this press release, and Elixirgen Therapeutics undertakes no obligation to update or revise the statementsin the future, even if new information becomes available.

ContactMedia RelationsElixirgen Therapeutics, Inc.(443) 869-5420Media@ElixirgenTherapeutics.com

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SOURCE Elixirgen Therapeutics

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Elixirgen Therapeutics planning to begin Phase I/II Clinical Trials of its COVID-19 Vaccine Candidate EXG-5003 at Fujita Health University - BioSpace

BRUSSELS (Reuters) - It is hard enough developing a vaccine in record time to halt a global pandemic. But what if you need to print the instructions with every dose in Portuguese, Lithuanian and Greek?

FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration/File Photo

Drugmakers are asking the European Union to loosen rules that require medicines sold in the bloc to include full documentation in 24 separate languages, worried that this could slow down the rapid deployment of hundreds of millions of doses.

We need an early agreement from EU authorities on the language to be used on the packs and labels for COVID-19 vaccines, said Michel Stoffel, head of regulatory affairs at Vaccines Europe, which represents big vaccine makers including GlaxoSmithKline, Sanofi and AstraZeneca.

He told Reuters the industry was pushing EU regulators to quickly choose one language for all 27 EU states for labelling, packaging and instructions on possible COVID-19 vaccines.

The EUs executive Commission promised in June it would temporarily soften language requirements for COVID-19 vaccines, but has not yet put forward a proposal. A spokesman said work was underway to be flexible without compromising on safety.

An EU official said Brussels was considering having printed information in a limited set of languages. Other versions would be available online.

An industry official said even that might be too difficult: labels may not have enough space for more than two versions.

Consumer groups say leaving any languages off of packaging could hurt patients, particularly those less capable of looking up details online.

The urgency of getting a vaccine should not be an excuse for companies to cut corners on consumer protection, said Monique Goyens, the head of BEUC which represents major European consumer organisations.

The EU translates all its rules into all member languages. Commission staff use English, French and German as working languages.

Reporting by Francesco Guarascio @fraguarascio; Editing by Josephine Mason and Peter Graff

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Thanks for the COVID vaccine, but can you say that in Estonian? - Reuters

Health officials are now working to build on existing immunization infrastructure, including expanding it, to make it work for COVID-19 vaccine distribution.

Author: khou.com

Published: 10:28 PM CDT August 28, 2020

Updated: 10:27 PM CDT August 28, 2020

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What will happen when we have a COVID-19 vaccine? - KHOU.com

Aug. 30 (UPI) -- Food and Drug Administration Commissioner Stephen Hahn said the agency would be willing to fast track a COVID-19 vaccube as the United States nears 6 million cases.

In an interview with Financial Times, Hahn said the FDA would consider an emergency authorization of a vaccine for the coronavirus before the completion of phase three clinical trials if it found it appropriate to do so.

"It is up to the [vaccine developer] to apply for authorization or approval and we make an adjudication of their application," he said. "If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination."

Hahn said the decision would not be politically influenced and would rather be based on science, medicine and data.

"We have a convergence of the COVID-19 pandemic with the political season, and we're just going to have to get through that and stick to our core principles," said Hahn.

He added that an emergency use authorization, like the one the agency issued last week for convalescent plasma treatments following criticism by President Donald Trump, is not the same as full approval.

"The legal, medical and scientific standard for that is that the benefit outweighs the risk in a public health emergency," Hahn said.

Hahn's comments come as the United States nears 6 million total COVID-19 cases, with a world-leading 5,969,916 reported as of Sunday afternoon, according to data collected by Johns' Hopkins University. The United States has also reported more deaths than any other nation since the start of the pandemic with a death toll of 182,909.

California reported 6,070 new cases on Sunday for a total of 699,909, as it leads the nation in total cases. The state also reported 71 new deaths for a death toll of 12,905 in third place behind New York and New Jersey.

Florida on Sunday reported 2,583 new COVID-19 cases, its lowest total since June after reporting a record high of 15,299 on July 12. The state is second in the nation with a total of 621,586 reported cases. Florida also reported 14 new resident deaths for a total of 11,119, also the lowest since 12 in June, and fifth overall.

Texas is third in the nation in total COVID-19 cases, reporting 3,759 new positives for a total of 610,354 and fourth in deaths at 12,510 after reporting 90 new fatalities.

New York Gov. Andrew Cuomo announced the state reported 698 new COVID-19 cases and eight new deaths on Sunday, as the state also set a record-high with 100,022 test results. The state leads the nation in deaths with 32,944 confirmed fatalities and is fourth in cases with a total of 434,100 after having been the U.S. epicenter of the virus.

SUNY Oneonta, a public college in central New York, announced Sunday it would suspend in-person classes for two weeks after they began on Monday.

The university has reported 105 positive cases since the start of the semester as of Sunday, while 36 students have been quarantined on campus and seven are in isolation. State University of New York Chancellor Jim Malatras is set to visit the university on Sunday after reports of "a number of large gatherings and parties" reported on campus.

Georgia reported 1,298 new cases for the fifth highest total in the nation at 268,973 and 28 new deaths for a total of 5,604. It's the first time cases fell under 1,300 since late June.

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FDA willing to fast track COVID-19 vaccine, as U.S. nears 6 million cases - UPI News

Fox News contributor Dr. Marc Siegel argues 100 million doses of AstraZenecas coronavirus vaccine could be ready by fall and he also discusses whether its possible to have another national lockdown.

Japan has moved to secure a half-billion doses of coronavirus vaccines in a bid to prove it can still host the Summer Olympics next year, according to reports.

Chief Cabinet Secretary Yoshihide Suga claimed that Japan was working with Olympic organizers on how to go ahead with the Games, emphasizing that a vaccine was essential to any effort to stage the event.

Various companies will probably be able to produce a vaccine between the end of this year and next March," Suga told Reuters in an interview this week. There are a lot of considerations, but we want to hold the Olympics at all costs.

The government is on track to secure 521 million doses of five different vaccines, more than four times its population of 126 million. Japan is working on arrangements with companies including Pfizer Inc., AstraZeneca PLCand even local companies such as Shionogi & Co.

You have to bet evenly to avoid getting nothing, said Tomoya Saito, director at Japans National Institute of Public Health.

A broad approach has been the norm, with other nations similarly striking deals with multiple drug makers to ensure that some vaccine will be available as soon as possible.

The U.S. government last month reached a $1.95 billion deal with Pfizer and BioNTech for 100 million doses of their experimental vaccine once it obtains Food and Drug administration approval.

MODERNA SAYS COVID-19 VACCINE SHOWS SIGNS OF WORKING IN OLDER ADULTS

"Adding a vaccine from Pfizer and BioNTech" to the government's Operation Warp Speed inoculation-development program "increases the odds that we will have a safe, effective vaccine as soon as the end of this year, Health and Human Services Secretary Alex Azar said in a statement.

A coalition of European governments have also worked on a deal with AstraZeneca.Spain joined France, Germany, Italy and the Netherlands to secure a supply of 400 million doses of the vaccine as of June 2020.

TRUMP TAPS MCKESSON AS CORONAVIRUS VACCINE DISTRIBUTOR

Prime Minister Shinzo Abe on Friday announced that he would resign as his health condition recently worsened, but his ambition to host the Olympics remains a priority for his government. Abe described his decision as gut wrenching, but necessary, the New York Times reported.

I think the Olympics would have been the one major thing he could point to and say, 'Yes,I did that. I made that happen,' David Leheny, a politics professor at Tokyos Waseda University, told the Times. He still might, and I think whoever the next prime minister is will ensure Abe has a prominent place at the Olympics, but it won't be the same as his being in charge to welcome people.

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During his resignation speech, Abe pledged that the government would secure enough vaccine for Japan by the middle of 2021 and that the nation would relax its travel ban from Sept. 1.

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Japan moves to secure half-billion doses of COVID-19 vaccine, hopeful of hosting delayed Summer Olympics - Fox Business

Minnesotans will likely need two separate doses of a coronavirus vaccine once one becomes available.

Minnesota is one of a handful of states working with the federal government to determine the best way to distribute vaccines against COVID-19 once they become available.

President Donald Trump has speculated a vaccine will be ready by the end of the year, but Minnesota health officials are being more cautious.

Kris Ehresmann, director of infectious disease and epidemiology for the state Department of Health, said past experiences with mass vaccinations have shown it is better to under promise and over deliver.

Prospective vaccines are already being produced by several manufacturers although they continue to be studied for safety and effectiveness. The U.S. government is funding that effort to help speed the availability of a vaccine once it is proven to work its nicknamed Project Warp Speed.

Minnesota health officials met online with leaders from the Centers for Disease Control and Prevention this week to provide input on who should be among the first to be vaccinated against the coronavirus that has killed 1,810 Minnesotans and sickened at least 73,240. Whenever a vaccine becomes available it will almost certainly be in short supply and high demand early on.

Erhesmann said state health officials recommended essential workers such as health care providers and long-term care staffers should be among the first to receive the vaccine.

Until a vaccine is released, state health officials continue to plead with residents to follow community mitigation measures in place to slow the spread of the coronavirus. They include wearing a mask, maintaining a social distance of six feet, staying home when you are sick and diligent hand washing.

COVID-19 has sickened more than 24.5 million worldwide and killed at least 830,000. In the U.S. more than 178,000 have died and 5.8 million have tested positive.

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Once a COVID-19 vaccine is here it will likely take two doses - TwinCities.com-Pioneer Press