Coronavirus vaccine – When Will it be ready?

When will a coronavirus vaccine be ready?

Human trials will begin imminently – but even if they go well and a cure is found, there are many barriers before global immunisation is feasible

When will a coronavirus vaccine be ready? Illustration by James Melaugh.
 When will a coronavirus vaccine be ready? Illustration by James Melaugh. Illustration: James Melaugh/The Observer

Even at their most effective – and draconian – containment strategies have only slowed the spread of the respiratory disease Covid-19. With the World Health Organization finally declaring a pandemic, all eyes have turned to the prospect of a vaccine, because only a vaccine can prevent people from getting sick.

About 35 companies and academic institutions are racing to create such a vaccine, at least four of which already have candidates they have been testing in animals. The first of these – produced by Boston-based biotech firm Moderna – will enter human trials imminently.

This unprecedented speed is thanks in large part to early Chinese efforts to sequence the genetic material of Sars-CoV-2, the virus that causes Covid-19. China shared that sequence in early January, allowing research groups around the world to grow the live virus and study how it invades human cells and makes people sick.

Coronaviruses have caused two other recent epidemics – severe acute respiratory syndrome (Sars) in China in 2002-04, and Middle East respiratory syndrome (Mers), which started in Saudi Arabia in 2012. In both cases, work began on vaccines that were later shelved when the outbreaks were contained. One company, Maryland-based Novavax, has now repurposed those vaccines for Sars-CoV-2, and says it has several candidates ready to enter human trials this spring. Moderna, meanwhile, built on earlier work on the Mers virus conducted at the US National Institute of Allergy and Infectious Diseases in Bethesda, Maryland.

Sars-CoV-2 shares between 80% and 90% of its genetic material with the virus that caused Sars – hence its name. Both consist of a strip of ribonucleic acid (RNA) inside a spherical protein capsule that is covered in spikes. The spikes lock on to receptors on the surface of cells lining the human lung – the same type of receptor in both cases – allowing the virus to break into the cell. Once inside, it hijacks the cell’s reproductive machinery to produce more copies of itself, before breaking out of the cell again and killing it in the process.

All vaccines work according to the same basic principle. They present part or all of the pathogen to the human immune system, usually in the form of an injection and at a low dose, to prompt the system to produce antibodies to the pathogen. Antibodies are a kind of immune memory which, having been elicited once, can be quickly mobilised again if the person is exposed to the virus in its natural form.

Traditionally, immunisation has been achieved using live, weakened forms of the virus, or part or whole of the virus once it has been inactivated by heat or chemicals. These methods have drawbacks. The live form can continue to evolve in the host, for example, potentially recapturing some of its virulence and making the recipient sick, while higher or repeat doses of the inactivated virus are required to achieve the necessary degree of protection. Some of the Covid-19 vaccine projects are using these tried-and-tested approaches, but others are using newer technology. One more recent strategy – the one that Novavax is using, for example – constructs a “recombinant” vaccine. This involves extracting the genetic code for the protein spike on the surface of Sars-CoV-2, which is the part of the virus most likely to provoke an immune reaction in humans, and pasting it into the genome of a bacterium or yeast – forcing these microorganisms to churn out large quantities of the protein. Other approaches, even newer, bypass the protein and build vaccines from the genetic instruction itself. This is the case for Moderna and another company which has a presence in Boston, CureVac, both of which are building Covid-19 vaccines out of messenger RNA.

Cepi’s original portfolio of four funded Covid-19 vaccine projects was heavily skewed towards these more innovative technologies, and last week it announced $4.4m (£3.4m) of partnership funding with Novavax and with a University of Oxford vectored vaccine project. “Our experience with vaccine development is that you can’t anticipate where you’re going to stumble,” says Hatchett, meaning that diversity is key. And the stage where any approach is most likely to stumble is clinical or human trials, which, for some of the candidates, are about to get under way.

Clinical trials, an essential precursor to regulatory approval, usually take place in three phases. The first, involving a few dozen healthy volunteers, tests the vaccine for safety, monitoring for adverse effects. The second, involving several hundred people, usually in a part of the world affected by the disease, looks at how effective the vaccine is, and the third does the same in several thousand people. But there’s a high level of attrition as experimental vaccines pass through these phases. “Not all horses that leave the starting gate will finish the race,” says Bruce Gellin, who runs the global immunisation programme for the Washington DC-based nonprofit, the Sabin Vaccine Institute.

There are good reasons for that. Either the candidates are unsafe, or they’re ineffective, or both. Screening out duds is essential, which is why clinical trials can’t be skipped or hurried. Approval can be accelerated if regulators have approved similar products before. The annual flu vaccine, for example, is the product of a well-honed assembly line in which only one or a few modules have to be updated each year. In contrast, Sars-CoV-2 is a novel pathogen in humans, and many of the technologies being used to build vaccines are relatively untested too. No vaccine made from genetic material – RNA or DNA – has been approved to date, for example. So the Covid-19 vaccine candidates have to be treated as brand new vaccines, and as Gellin says: “While there is a push to do things as fast as possible, it’s really important not to take shortcuts.”

An illustration of that is a vaccine that was produced in the 1960s against respiratory syncytial virus, a common virus that causes cold-like symptoms in children. In clinical trials, this vaccine was found to aggravate those symptoms in infants who went on to catch the virus. A similar effect was observed in animals given an early experimental Sars vaccine. It was later modified to eliminate that problem but, now that it has been repurposed for Sars-CoV-2, it will need to be put through especially stringent safety testing to rule out the risk of enhanced disease.

It’s for these reasons that taking a vaccine candidate all the way to regulatory approval typically takes a decade or more, and why President Trump sowed confusion when, at a meeting at the White House on 2 March, he pressed for a vaccine to be ready by the US elections in November – an impossible deadline. “Like most vaccinologists, I don’t think this vaccine will be ready before 18 months,” says Annelies Wilder-Smith, professor of emerging infectious diseases at the London School of Hygiene and Tropical Medicine. That’s already extremely fast, and it assumes there will be no hitches.

In the meantime, there is another potential problem. As soon as a vaccine is approved, it’s going to be needed in vast quantities – and many of the organisations in the Covid-19 vaccine race simply don’t have the necessary production capacity. Vaccine development is already a risky affair, in business terms, because so few candidates get anywhere near the clinic. Production facilities tend to be tailored to specific vaccines, and scaling these up when you don’t yet know if your product will succeed is not commercially feasible. Cepi and similar organisations exist to shoulder some of the risk, keeping companies incentivised to develop much-needed vaccines. Cepi plans to invest in developing a Covid-19 vaccine and boosting manufacturing capacity in parallel, and earlier this month it put out a call for $2bn to allow it to do so.

Once a Covid-19 vaccine has been approved, a further set of challenges will present itself. “Getting a vaccine that’s proven to be safe and effective in humans takes one at best about a third of the way to what’s needed for a global immunisation programme,” says global health expert Jonathan Quick of Duke University in North Carolina, author of The End of Epidemics (2018). “Virus biology and vaccines technology could be the limiting factors, but politics and economics are far more likely to be the barrier to immunisation.”

The problem is making sure the vaccine gets to all those who need it. This is a challenge even within countries, and some have worked out guidelines. In the scenario of a flu pandemic, for example, the UK would prioritise vaccinating healthcare and social care workers, along with those considered at highest medical risk – including children and pregnant women – with the overall goal of keeping sickness and death ra tes as low as possible. But in a pandemic, countries also have to compete with each other for medicines.

Because pandemics tend to hit hardest those countries that have the most fragile and underfunded healthcare systems, there is an inherent imbalance between need and purchasing power when it comes to vaccines. During the 2009 H1N1 flu pandemic, for example, vaccine supplies were snapped up by nations that could afford them, leaving poorer ones short. But you could also imagine a scenario where, say, India – a major supplier of vaccines to the developing world – not unreasonably decides to use its vaccine production to protect its own 1.3 billion-strong population first, before exporting any.

Outside of pandemics, the WHO brings governments, charitable foundations and vaccine-makers together to agree an equitable global distribution strategy, and organisations like Gavi, the vaccine alliance, have come up with innovative funding mechanisms to raise money on the markets for ensuring supply to poorer countries. But each pandemic is different, and no country is bound by any arrangement the WHO proposes – leaving many unknowns. As Seth Berkley, CEO of Gavi, points out: “The question is, what will happen in a situation where you’ve got national emergencies going on?”

This is being debated, but it will be a while before we see how it plays out. The pandemic, says Wilder-Smith, “will probably have peaked and declined before a vaccine is available”. A vaccine could still save many lives, especially if the virus becomes endemic or perennially circulating – like flu – and there are further, possibly seasonal, outbreaks. But until then, our best hope is to contain the disease as far as possible. To repeat the sage advice: wash your hands.

  • This article was amended on 19 March 2020. An earlier version incorrectly stated that the Sabin Vaccine Institute was collaborating with the Coalition for Epidemic Preparedness Innovations (Cepi) on a Covid-19 vaccine. It was further amended on 30 March to remove an incorrect reference to CureVac being a “Boston company”; its world headquarters are in Tübingen, Germany.

  • Due to the unprecedented and ongoing nature of the coronavirus outbreak, this article is being regularly updated to ensure that it reflects the current situation at the date of publication. Any significant corrections made to this or previous versions of the article will continue to be footnoted in line with Guardian editorial policy.

Coronavirus Cases in U.S. CDC

This page will be updated daily. Numbers close out at 4 p.m. the day before reporting.

***On Saturday and Sunday, the numbers in COVID-19: U.S. at a Glance and the figure describing the cumulative total number of COVID-19 cases in the United States will be updated. These numbers are preliminary and have not been confirmed by state and territorial health departments. CDC will update weekend numbers the following Monday to reflect health department updates.***

New Data Available: CDC publishes COVIDView: a weekly surveillance summary of U.S. COVID-19 activity.

CDC is responding to an outbreak of respiratory illness caused by a novel (new) coronavirus. The outbreak first started in Wuhan, China, but cases have been identified in a growing number of other locations internationally, including the United States. In addition to CDC, many public health laboratories are now testing for the virus that causes COVID-19.

COVID-19: U.S. at a Glance*†
  • Total cases: 374,329
  • Total deaths: 12,064
  • Jurisdictions reporting cases: 55 (50 states, District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands, and the U.S. Virgin Islands)

* Data include both confirmed and presumptive positive cases of COVID-19 reported to CDC or tested at CDC since January 21, 2020, with the exception of testing results for persons repatriated to the United States from Wuhan, China and Japan. State and local public health departments are now testing and publicly reporting their cases. In the event of a discrepancy between CDC cases and cases reported by state and local public health officials, data reported by states should be considered the most up to date.

† Numbers updated Saturday and Sunday are not confirmed by state and territorial health departments. These numbers will be modified when numbers are updated on Monday.

New Weekly COVID-19 Surveillance Report
COVIDView Newsletter

New COVIDView
A weekly surveillance summary of U.S. COVID-19 activity. The report summarizes and interprets key indicators including information related to COVID-19 outpatient visits, emergency department visits, hospitalizations and deaths, as well as laboratory data.
COVIDViewpdf icon

Hospitalizations
U.S. COVID-19 lab-confirmed hospitalizations for all ages.

Mortality
Provisional Death Counts for COVID-19 and pneumonia.

Source: CDC https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html

 

COVID-19 Summary (Updated 3/30): Important Updates

COVID-19 Summary (Updated 3/30): Important Updates

Below is a summary of the relevant information that impacts home health and hospice providers related to
the COVID-19 pandemic. The information is a compilation of information from various sources, including
the federal government, NAHC, home care consultants, and stakeholders. Some information has not changed
since the beginning of the COVID-19 outbreak. Other related information is more fluid and will change as
more cases of COVID-19 are identified. This document will be updated as needed.
Patients
• Separate yourself from other people and animals in your home.
• Avoid close contact with others — 6 feet or greater
• Wear a facemask if possible, patients may have to use tissues or other barriers to cover their mouth
and nose with supply shortages
• Cough into a tissue and dispose immediately in lined trash can
• Clean your hands with soap and water for 20 seconds often and after using the restroom
• Avoid sharing personal household items for example plates, cups, silverware. Consider plastic
utensils and paper plates
• Clean all “high-touch” surfaces everyday, e.g. countertops, doorknobs, etc. See recommended
disinfectants for COVID-19
Patient Guide for COVID-19 (docx)
Caregiver Guide for COVID-19 (docx)
Guide for Cleaning and Disinfecting COVID-19 (docx)
Home Health and Hospice Staff
Agency staff caring for suspected or confirmed COVID-19 patients must adhere to standard and
transmission precautions.
• Respirator N95 or higher
• Gowns
• Gloves
• Eye protection
The CDC issued interim guidance to permit the use of face masks in areas where N95 respirators are
unobtainable.
N95 respirators are to be used routinely when available, and must be used when aerosol-generating procedures
are performed. If there is a shortage, face masks can be worn for respiratory protection.
Shortages of PPE is a problem in all healthcare sectors. Preserving the PPE supply that you have now is key.
Eye protection (which is required when a face mask or respirator is used) can be re-used when it is not
touched during use, carefully removed, and cleaned and disinfected after use, and properly stored.
CDC recently updated guidance for preserving PPE. CDC outlines strategies for PPE use and preservation
based on the severity of shortages.
CDC is not recommending patients wear masks during shortages. Patients with symptoms of respiratory
infection should be instructed to use tissues or other barriers to cover their mouth and nose.
Hand hygiene needs to be performed before and after removing PPE. For hand hygiene supplies, the FDA is
now permitting pharmacies to compound alcohol-based hand sanitizer and that’s another option for you to
access this supply.
The treatment of COVID-19 patients in the home might include collection of specimens for testing,
observation and assessment, and providing more advanced interventions such as intravenous therapy. The
degree that home health agencies will be involved in caring for COVID-19 confirmed patients is unclear but
agencies should be prepared.
Preserving the PPE supply that you have now is key.
• Ensure staff is using PPE appropriately.
• Use out dated equipment for training
• Know what you have in stock and what your usage is.
• Do not discard expired equipment
The treatment of COVID-19 patients in the home might include collection of specimens for testing,
observation and assessment, and more advanced interventions, such as, intravenous therapy. The degree that
home health agencies will be involved in caring directly for COVID-19 confirmed patients is unclear but
agencies should be prepared.
https://www.nahc.org/wp-content/uploads/2020/03/COVID-19-Guidance-Document.pdf
https://www.nahc.org/wp-content/uploads/2020/03/Coronavirus-Checklist-3-16-20-guidance-1.pdf
Frequently Asked Question related to Medicaid and CHIP
https://www.cms.gov/newsroom/press-releases/cms-publishes-first-set-covid-19-frequently-askedquestions-faqs-state-medicaid-and-childrens-health
Regulatory and Operations
Waivers (updated 3/20)
CMS issued 1135 blanket waivers for the entire nation retroactively effective back to March 1, 2020 for those
providers impacted by the COVID-19 outbreak.
The blanket waivers specific to home health include the following:
o Provides relief to Home Health Agencies on the timeframes related to OASIS Transmission.
o Allows Medicare Administrative Contractors to extend the auto-cancellation date of Requests for
Anticipated Payment (RAPs) during emergencies.
There are several other waivers related to provider enrollment requirements that impact all
providers including home health and hospices agencies. They are:
o Waive the following screening requirements
o Application Fee – 42 C.F.R 424.514
o Criminal background checks associated with FCBC -42 C.F.R 424.518
o Site visits – 42 C.F.R 424.517
o Postpone all revalidation actions
o Allow licensed providers to render services outside of their state of enrollment
o Expedite any pending or new applications from providers
The CMS has set up an email address 1135waiver@CMS.HHS.gov to submit waiver requests for other
provider-specific requests as the need arises.
https://www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf
Telehealth (updated 3/20)
Recent legislation provides for waivers on the originating site and geographic area restrictions.
CMS will permit practitioners to use an interactive audio and video telecommunications system that permits
real-time communication between the physician’s site and the patient at home. These changes mean that
physicians and practitioners (physicians, nurse practitioners, physician assistants, nurse midwives, certified
nurse anesthetists, clinical psychologists, clinical social workers, registered dietitians, and nutrition
professionals) may use telehealth in the home using face time in place of face to face visits, including the F2F
encounter for home health certification. NAHC is currently awaiting confirmation from CMS on the use of
telehealth for F2F visits for hospice recertification.
In addition the Office of Civil Rights issued a notice of enforcement discretion that will permit telehealth
technologies such as, Skype, Face Time with a smartphone, and Zoom. Without the waiver providers would
be violation of HIPAA rules if these technologies were used. These technologies do not meet HIPAA
security standards and were not developed for the purpose of delivering telehealth services. Therefore, it is
acceptable at this time for both home health and hospice providers to communicate with patients using
telehealth. However, it is not clear if CMS will consider these visits covered/paid.
CMS has issued guidance on using telehealth for the home health physician F2F encounter during the
COVID-19 pandemic. CMS will permit a physician to conduct the F2Fencounter via telehealth in the
patient’s home.
Available here https://www.cms.gov/files/document/03092020-covid-19-faqs-508.pdf
Additionally, with the recently announce HIPAA waiver, CMS confirmed for NAHC that the visit may be
conducted through technologies such as Skype, face time and Zoom. NAHC also received the following
additional clarification from CMS related to teleheath.
• The requirements for the F2F encounter have not changed, timeframe, relate to the primary reason
for home health services, and conducted by an allowed practitioner.
• There is no requirement that the HHA staff be present in the home while the encounter via
telehealth is being conducted.
• Physician documentation of the visit should reflect what is typically required for telehealth visits.
CMS recognizes that certain elements such as vital signs may not be part of telehealth visit note, and
does not require such for the F2F encounter. CMS pointed to the discharge summary as an example
of a F2F encounter note where all element of a typical physician visit note are not always included.

Further, NAHC is seeking clarification on POC and documentation requirements when agencies must
conduct visits virtually in place of on-site visits.
https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
https://www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notificationenforcement-discretion-telehealth/index.html
https://edit.cms.gov/files/document/medicare-telehealth-frequently-asked-questions-faqs-31720.pdf
Medicare Cost Reports (new 3/24)
CMS is currently authorizing delay for the following FYE dates.
The filing deadline for the following cost reports are now June 30, 2020:
• FYE October 31, 2019 due by March 31, 2020
• FYE November 30, 2019 due by April 30, 2020
Accelerated/Advanced payments (3/27)
Upon request, CMS will provide accelerated payments to Medicare Part A providers and advance payments to
Medicare Part B providers and suppliers impacted by the COVID-19 pandemic to provide cash relief for a
period of up to three months. CMS has instituted flexibilities to streamline the existing accelerated/advance
payment process to provide the MACs with temporary authorization to issue advance or accelerated
payments in order to effectuate timely processing and payment within seven calendar days of receipt of the
request.
All of the MACs have set up a hotline to address provider questions related to the accelerated payment
process.
Palmetto GBA
CGS GBA
NGS GBA
Survey and Certification (updated 3/24)
CMS has issued guidance on quality prioritizing surveys. Standard home health and hospice recertification
surveys and revisit surveys will not be conducted until further notice.
https://www.cms.gov/files/document/qso-20-20-all.pdf
CMS announced some quality reporting program relief for providers. For both home health and hospice
there are some data that do not need to be submitted, as follows:
Deadlines for October 1, 2019 – December 31, 2019 (Q4) data submission optional. If Q4 is submitted, it
will be used to calculate the 2019 performance and payment (where appropriate).
Data from January 1, 2020 through June 30, 2020 (Q1-Q2) does not need to be submitted to
CMS for purposes of complying with quality reporting program requirements. This means that Home Health
and Hospice Consumer Assessment of Healthcare Providers and Systems (CAHPS) survey data from January
1, 2020 through September 30, 2020 (Q1-Q3) does not need to be submitted to CMS.
https://www.cms.gov/newsroom/press-releases/cms-announces-relief-clinicians-providers-hospitals-andfacilities-participating-quality-reporting
CMS issued a COVID-19 guidance document for home health and hospice providers:
https://www.cms.gov/files/document/qso-20-18-hha.pdf
https://www.cms.gov/files/document/qso-20-16-hospice.pdf
Sources
Mary McGoldrick, MS, RN, CRNI, Home Care and Hospice Consultant, Home Health Systems, Inc.
Barbara B. Citarella, RN, BSN, MS, CHCE, NHDP-BC (National Healthcare Disaster Professional),
President and CEO, RBC Limited Healthcare & Management Consultants
Centers for Disease Control and Prevention, COVID-19 resources
Office of Civil Rights, Heath Insurance Portability and Accountability Act
Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality/Quality, Safety &
Oversight Group
Updated 3/30/2020

 

Source: Homecare & Hospice https://www.nahc.org/wp-content/uploads/2020/03/COVID-Summary033020.pdf

 

 

CDC Corona Virus Resources

CDC Corona Virus Resources