PART 89. December 12, 2020. CORONAVIRUS. THE VACCINE!!! “Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.” Winston Churchill

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“There are known knowns. These are things we know that we know. There are known unknowns. That is to say, there are things that we know we don’t know. But there are also unknown unknowns. There are things we don’t know we don’t know.”  Donald Rumsfeld

“A US Centers for Disease Control and Prevention advisory committee voted Saturday to recommend the Pfizer and BioNTech Covid-19 vaccine in patients 16 and older as the US continues to be ravaged by the coronavirus

The vote by the CDC’s Advisory Committee on Immunization Practices came the day after the US Food and Drug Administration authorized the Pfizer vaccine for emergency use — a day in which the US once again saw a record number of new cases, deaths and Covid-19 patients in hospitals.

Vaccines cannot be administered until CDC Director Dr. Robert Redfield accepts the committee’s recommendation, which is expected to take place within hours…

The first shipments of Pfizer and BioNTech’s Covid-19 vaccine will leave Kalamazoo, Michigan, on Sunday after the FDA authorized the vaccine for emergency use, a landmark in the pandemic.

The Food and Drug Administration’s authorization came amid one of the worst days of the pandemic for the US, with record numbers of new cases, deaths and Covid-19 patients in US hospitals.

The emergency use authorization (EUA) is a “significant milestone,” FDA Commissioner Dr. Stephen Hahn said in a statement Friday. He said it comes after an “open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists.”

An EUA stops short of a full approval. Pfizer would have to file a separate application for its vaccine to be fully licensed by the FDA.

But the EUA “holds the promise to alter the course of this pandemic in the United States,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

Once the vaccines leave Pfizer’s Kalamazoo facility, they’ll be bound for 636 locations across the country, Gen. Gustave Perna, chief operating officer of the federal government’s vaccine initiative Operation Warp Speed, said in a news conference Saturday.

“We expect 145 sites across all the states to receive the vaccine on Monday, another 425 sites on Tuesday, and the final 66 sites on Wednesday, which will complete the initial delivery of the Pfizer orders for the vaccine,” Perna added.

But two key steps remain before vaccinations can start. The US Centers for Disease Control and Prevention vaccine advisory committee met Saturday morning and must vote to recommend the vaccine. The agency next must accept that recommendation.

Then vaccinations can begin. But it will be months before most Americans will get one. Advisers to the CDC have recommended healthcare workers and long-term care facility residents be first in line.” (A)

“The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.” (B)   

“A lot of things are different when you’re in the midst of a global pandemic. A case in point: How federal regulators scrutinize and authorize new vaccines.

The U.S. Food and Drug Administration ushered in a new phase of the fight against COVID-19 on Friday by giving its blessing to a vaccine made by Pfizer Inc. and BioNTech. It’s the first such vaccine to get a green light from the FDA, and immunizations will begin in a matter of days.

There are plenty of reasons why it passed muster. Clinical trial data indicate that:

• It was 95% effective at preventing cases of COVID-19 in both Latinos and non-Latinos.

• It was 100% effective in Black people.

• It was 94% effective in people who were at least 56 years old. (The older you get, the greater the risk of a serious case of COVID-19.)

• It was 95% effective in those who had at least one medical condition that made them more likely to develop a serious case of COVID-19.

• It was 96% effective for people who were obese, another condition that makes people more vulnerable to COVID-19.

Yet none of this was enough for the vaccine to win official FDA approval. What it got instead was a more limited emergency use authorization.

Why?

Blame it on the pandemic.

During a public health emergency, it’s imperative to develop new medicines and vaccines as quickly as possible. But even when speed is of the essence, the FDA still takes the time to be sure patients aren’t subjected to untested therapies that do more harm than good.

So the agency uses an alternative evaluation process that’s designed to vet things more quickly than the usual FDA approval regimen. If a drug or vaccine passes muster, it’s granted an emergency use authorization, or EUA.

An EUA can be used on a brand-new medical product or on an existing one that has already been approved for another purpose. They’re not limited to vaccines — under the right circumstances, an EUA can be granted to anything used to “diagnose, treat, or prevent serious or life-threatening diseases or conditions,” the FDA explains….

Once sufficient data are in hand, the FDA can decide whether emergency use authorization is warranted. Doctors and scientists on the agency’s staff pore over the study results. So do the independent scientists and health experts on the agency’s Vaccines and Related Biological Products Advisory Committee.

In the case of a vaccine, authorization can be granted if “the known and potential benefits outweigh the known and potential risks,” the FDA says.

The agency also assesses the company’s ability to consistently produce high-quality doses of its vaccine.

Granting emergency use authorization isn’t the end of the story. Once an authorized vaccine goes out to the public, its manufacturer must keep track of any serious side effects that befall those who take it, especially adverse events that result in hospitalization or even death.

The FDA, the Centers for Disease Control and Prevention and other government agencies will do their own safety monitoring as well. If the FDA ever determines that the benefits of the vaccine no longer outweigh the harms, the emergency use authorization can be revoked.

An EUA can last only as long as a public health emergency is in effect. But scientists anticipate that the coronavirus will continue to circulate in humans even after the COVID-19 pandemic ends. In that case, vaccine makers that want to keep their products on the market will need to have regular FDA approval — and to get it, they’ll need to keep their Phase 3 clinical trials going.

And that’s probably what they’ll do. The FDA said it expects vaccine makers who receive emergency use authorizations to “continue to collect placebo-controlled data in any ongoing trials for as long as feasible” so they can apply for regular approval.” (C)

“Pfizer has a deal with the U.S. government to supply 100 million doses of the vaccine by next March. Under that agreement, the shots will be free to the public.

Every state, along with six major cities, has submitted to the federal government a list of locations — mostly hospitals — where the Pfizer vaccine is to ship initially. In populous Florida, the first recipients will be five hospitals, in Jacksonville, Miami, Orlando, Tampa and Hollywood. In tiny, rural Vermont, only the University of Vermont Medical Center and a state warehouse will get supplies.

McKesson Corporation, a giant medical supplier, is sending kits of syringes, alcohol pads, face shields and other supplies to the same sites, where they will meet up with the vaccines that Pfizer is shipping in special boxes, packed with dry ice, designed to keep them at minus 94 degrees Fahrenheit.

The Pfizer packaging will include a device that tracks the location of the box, plus a thermal probe that will make sure the deep freeze is maintained throughout the journey from the company’s distribution sites in Michigan and Wisconsin.” (D)

CDC requested each state outline its capacities for distributing COVID-19 vaccines across a broad set of 15 critical areas: public health preparedness planning; organizational structure; plans for a phased approach; identifying and reaching critical populations to be prioritized for vaccine access; identifying and recruiting providers to administer the vaccine; vaccine administration capacity; allocating, distributing, and managing its inventory of vaccines; storage and handling; collecting, tracking, and reporting key measures of progress; second dose reminders; immunization information system requirements; developing a comprehensive communications plan around vaccination; regulatory considerations; safety monitoring; and program monitoring.

CDC guidance and federal oversight could evolve over the next several months as vaccines become available and distribution begins. The Biden campaign and transition team have planned for a more prominent role for the federal government in the U.S. COVID-19 response, which would likely include more detailed federal guidance and a stronger federal hand in vaccine distribution, planning and implementation, even as state and local jurisdictions will remain responsible for much of this effort. A critical challenge facing vaccine distribution efforts will be funding. To date, only $200 million has been distributed to state, territorial, and local jurisdictions for vaccine preparedness, though it is estimated that at least $6-8 billion is needed. President-elect Biden has said his administration would seek to invest $25 billion in manufacturing and distribution, which would require Congressional action.

While the CDC has made executive summaries of these plans available, there is no central repository for the full plans. We therefore sought to collect plans available from all 50 states and DC, as of November 13, identifying 47 full state plans in total (linked in the “State Plans” tab). We then reviewed each plan to gauge how states described their vaccine distribution planning progress to date. Rather than assess every single component of these plans in detail we identified common themes and concerns across the state plans, in particular focusing on what states reported regarding their progress in the following key areas:

identifying priority populations for vaccination in their state;

identifying the network of providers in their state that will be responsible for administering vaccines;

developing the data collection and reporting systems needed to track vaccine distribution progress; and

laying out a communications strategy for the period before and during vaccination.

Where are States in their Planning?

Based on the information in their plans, states are in varying stages of preparation for distributing a COVID-19 vaccine. While all have established a task force or planning committee to steer these efforts, which include representatives from different sectors, some have been planning for several months while other states’ planning efforts have started more recently. Some states have already begun the process of signing up providers to administer COVID-19 vaccines and building out existing immunization registries, while others are still just developing plans to do the same. All reported, however, that these initial plans are to be considered drafts only, to be updated as more information from the federal government and about a vaccine itself was available. Specifically, almost all cited the need to know which vaccine(s) would be authorized or approved, and that they will look to further federal guidance and recommendations before some key decisions are made, such as finalizing which individuals will be targeted as priority populations. Several raised concerns about the lack of visibility regarding vaccine distributions that will be made directly from the federal government to certain providers in their states, such as large pharmacy chains. These concerns were raised before the November 12 announcement by the federal government that it will be distributing future COVID-19 vaccines directly to some independent pharmacies and multi-state pharmacy chains across the U.S., in parallel to state efforts to recruit vaccination providers. States also discussed lessons learned from previous vaccine distribution efforts such as H1N1 pandemic influenza, including the need to build flexibility into distribution plans when supply is unpredictable and tailoring messages and outreach to diverse populations, which are certain to be challenges for a COVID-19 vaccine as well. Finally, even recognizing the that states are in different states of readiness in terms of their distribution planning efforts, it is clear all state health departments are taking this responsibility seriously and are overseeing significant efforts to make progress in their preparations. (E)

Training for Healthcare Providers

When COVID-19 vaccines become available, health departments will be key partners in ensuring the success of the COVID-19 Vaccination Program, including by offering training to healthcare providers in vaccine management, administration, and reporting. Onboarding opportunities will focus on:

ACIP COVID-19 vaccine recommendations, when available

How to order and receive COVID-19 vaccine

COVID-19 vaccine storage and handling (including transport requirements)

How to administer vaccine, including reconstitution, use of adjuvants, appropriate needle size, anatomic sites for vaccine administration, avoiding shoulder injury with vaccine administration, etc.

How to document and report vaccine administration via the jurisdiction’s Immunization Information System (IIS) or other external system

How to manage vaccine inventory, including accessing and managing product expiration dates

How to report vaccine inventory

How to manage temperature excursions

How to document and report vaccine wastage/spoilage

Procedures for reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS)

How to help patients enroll in v-safe, a smartphone-based tool that checks in with patients to ask about side-effects after receiving COVID-19 vaccine

Providing Emergency Use Authorization (EUA) fact sheets or Vaccine Information Sheets (VISs) to vaccine recipients

How to submit facility information for COVID-19 vaccination clinics to CDC’s Vaccine(F)

“Hours before the Food and Drug Administration authorized the first COVD-19 vaccine late Friday, a high-ranking White House official told the agency’s chief he could face firing if the vaccine was not cleared by day’s end, two administration officials said.

The FDA granted emergency use for the vaccine produced by Pfizer Inc. and its German partner BioNTech. The decision kicks off a massive vaccination effort to help defeat the pandemic. President Donald Trump said late Friday that Pfizer had “passed the gold standard of safety” and hailed the vaccine as “one of the greatest scientific accomplishments in history.”

But the move followed tense discussions between White House chief of staff Mark Meadows and FDA Commissioner Stephen Hahn, according to a senior administration official who was familiar with the call but was not authorized to discuss private conversations.

The chief of staff told Hahn his job was in jeopardy if the emergency use authorization was not issued before Saturday, said a second administration official familiar with the conversation.” (G)

“The ACA requires most employer and individual market health plans to cover and waive cost-sharing (such as a deductible, co-payment, or coinsurance) for certain recommended preventive services. These include immunizations for “routine use” in children and adults that have been recommended by ACIP; vaccines are only considered to be for routine use if they are listed on the Immunization Schedules of the Centers for Disease Control & Prevention (CDC).

The ACA gave plans and insurers up to two years to cover a vaccine, following the ACIP recommendation. It was for this reason that the Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted in March 2020, accelerated the timetable with a provision requiring insurers and employer plans to cover COVID-19 vaccines within 15 days after a recommendation from ACIP.

Other limitations in current law could leave consumers without full coverage of the vaccine:

The ACA requirement applies only to ACA-compliant health plans. Grandfathered plans, short-term plans, health care sharing ministries, Farm Bureau plans, and certain other forms of health insurance are not required to cover the vaccine at all, let alone waive enrollee cost-sharing. Although comprehensive data is not available, these alternative forms of coverage appear to be quite prevalent. For example, 14 percent of workers with job-based coverage are in a grandfathered plan, while at least 4-5 million individuals are enrolled in a short-term plan or sharing ministry arrangement.[1]

Health plans are not required to cover preventive services, including immunizations, delivered by an out-of-network provider, if an in-network provider is available to deliver the same service. If a consumer receives the vaccine from a clinic, urgent care center, or other provider who does not participate in their health plan’s network, they could find themselves responsible for the cost, in whole or in part.

If the provider charges the insurer separately for both an office visit and administration of the vaccine, the insurer is prohibited from imposing cost-sharing for the vaccine administration, but can impose cost-sharing for the office visit. Similarly, if the primary reason of the patient’s visit is for something other than receiving the vaccine, the patient may be charged for the visit.

Consumers who receive the vaccine in hospital-owned facilities or practices could face “facility fees,” meaning charges that are added to the bill to cover the cost of maintaining the facility. Not all health plans will cover these fees, leaving the policyholder to pay any outstanding balance, which can sometimes be hundreds of dollars.” (I)

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