Frequently Asked Questions about COVID-19 Vaccines
Tuesday, April 13, 2021
CDC calls for pause of J&J vaccine
On April 13, 2021, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued a joint statement recommending a pause in the use of the Johnson & Johnson (J&J) COVID-19 vaccine.
This is being done out of an abundance of caution, based on six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these six cases, a cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
More than 6.8 million doses of the J&J vaccine have been administered in the U.S. It’s notable for being a single-dose vaccine, rather than the two-dose vaccines produced by Pfizer and Moderna.
CVS has notified RxBenefits they are immediately implementing a pause until further notice in the use of the J&J vaccine based on the CDC / FDA recommendation. They are emailing all customers who were scheduled to receive the J&J vaccine to inform them the appointment is being cancelled. CVS Pharmacy locations will continue to offer the Moderna and Pfizer vaccines, and will reschedule the cancelled appointments as soon as possible.
In addition, CVS is not rejecting any J&J COVID-19 vaccine claims submitted at this time.
RxBenefits is working with ESI and OptumRx to determine their stance on the CDC / FDA recommendation.
Q. What do we know today about COVID-19 vaccines in terms of approvals and timing, including Emergency Use Authorization (EUA)?
A. There are several COVID-19 vaccines in late-stage clinical development in the U.S. and globally. Pfizer’s Messenger RNA vaccine was approved by the Food and Drug Administration (FDA) for EUA on Friday, December 11, 2020. Moderna’s Messenger RNA vaccine vaccine was approved by the Food and Drug Administration (FDA) for EUA on Friday, December 18, 2020. Others are expected to follow shortly.
The FDA has a review process to issue emergency use authorizations before vaccines are authorized for use by the general public. Since the COVID-19 vaccine situation is changing quickly, the Centers for Disease Control and Prevention (CDC) website is the best resource for COVID-19 information.
Following is the high-level status of approvals and timing for the current leading vaccine candidates.
|Vaccine Type||Manufacturer||Status of Trials||FDA Approval Status|
|Messenger RNA||Pfizer||Phase 3 completed||Approved for EUA in patients 16 and older|
|Messenger RNA||Moderna||Phase 3 completed||Submitted for EUA|
|Viral Vector||Astra Zeneca||Phase 3 in process||Expected in early 2021|
|Viral Vector||Janssen||Phase 3 in process||Expected in 1Q21|
|Protein Sub-unit||Novavax||Phase 3 in process||Expected in 2021|
|Protein Sub-unit||Sanofi / GSK||Phase 1/2 results expected in December 2020||Expected in late 2021|
Q. What are the differences between the leading vaccine candidates?
A. Vaccine manufacturers are utilizing three main platforms to develop their therapeutics. A central theme is that all vaccine candidates are focusing on developing immunity to the “s protein”; this is a component of the COVID-19 virus that allows it to attach to receptors within our body and infect our cells. By developing vaccines that promote an immune response in our body against this specific protein, the available clinical trial data has shown encouraging results in preventing significant disease and/or transmission.
A primary difference between the candidates is storage requirements; some require deep freezing, while others need only simple refrigeration.
Q. How soon after FDA Authorization will the vaccine be available for administration?
A. Federal health officials indicate initial doses will be shipped within 24 hours of FDA authorization and immunizations could begin within about 48 hours.
Q. Have the Pfizer and Moderna vaccines been shipped? Where?
A. Yes; Pfizer began shipping their vaccine on December 12; Moderna began shipping vaccines on December 20. Quantities and shipping locations are being determined at the state level.
Q. Is there a way to determine how many doses of the vaccine are being sent to each state?
A. The Washington Post has created a vaccine tracker on its website which provides that information.
Q. Are the leading vaccines safe? What do we know about the safety of the vaccines given the fast-track process?
A. While the development of COVID vaccines has been fast tracked via Operation Warp Speed, the FDA has reiterated that no safety precautions or criteria have been compromised. The FDA is expected to convene a meeting of the Vaccine and Related Products Advisory Committee (VRBPAC) prior to any approval. The VRBPAC is an advisory committee to the FDA and is comprised of independent experts in the fields of vaccine safety and infectious disease.
Based on Phase 3 trials, both Pfizer and Moderna have reported positive safety outcomes. The Pfizer trial reported side effects of fatigue and headache in only 3.8% and 2% of participants respectively. The Moderna trial reported injection site pain at 2.7%, and after the second dose included fatigue (9.7%), muscle pain (8.9%), joint pain (5.2%), headache (4.5%), and redness at the injection site (2.0%).
Q. How effective are the leading vaccines in preventing the coronavirus?
A. Both Moderna and Pfizer have reported Phase 3 trial efficacy at ~95%. This represents the degree to which the vaccines prevent the occurrence of symptomatic COVID-19 disease. The FDA requires >50% efficacy for approval. Both report that efficacy was consistent across age, gender, race, and ethnicity demographics.
Q. How many doses are required for the leading vaccines?
A. Of the leading vaccine candidates, most require two doses, including the Pfizer and Moderna vaccines. Only the Janssen vaccine is a one-dose vaccine.
Q. What is the timing between the first and second doses of the vaccine?
A. The timing between the first and second dose varies by vaccine. For the two leading vaccines, the doses are separated by 28 days for the Moderna vaccine and 21 days for the Pfizer vaccine.
Q. How long after the vaccine is given is it effective and protecting the individual?
A. The CDC states it typically takes a few weeks for the body to build immunity after vaccination. This means it is possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and get sick. This is because the vaccine has not had enough time to provide protection.
Q. Will the vaccine need to be given each year?
A. At this time, the answer is unclear. Viruses tend to mutate over time, plus we do not yet completely understand how long vaccinations may provide protection from COVID-19 infection. This is a matter that will continue to be studied by the medical and scientific community.
Q. How will the PBMs help ensure patients receive their second dose from the same manufacturer?
A. Individual states are required to maintain electronic immunization registries to track which residents have gotten which vaccines, when, and from what provider. Most vaccine providers (i.e., pharmacies and physicians’ offices) connect their records directly to these state registries. The CDC also is rolling out a new Vaccine Administration Management System (VMAS) to supplement existing state registries and support providers who may not be electronically connected to existing state registries. The CDC also will require providers administering vaccines to provide dose-level accounting and reporting so the agency can track where doses of vaccine are at any point in time.
ESI has implemented separate messaging to help augment this – a Therapy Duplication reject alert. If triggered, the message to pharmacies will be: “Use same manufacturer as first dose.”
This message will be visible to pharmacies even if they block secondary messaging. The pharmacist will need to enter an override code to continue.
Q. Will there be any claims edits in place to ensure the first dose was administered prior to the second dose?
A. PBMs will rely on the Submission Clarification Code submitted by the pharmacy in the event the first dose was not submitted through the same benefit. The first and second dose is likely to be the same NDC.
Q. Will vaccine claims be processed as brand medications? Generics? Other?
A. There are currently two NDCs for vaccines to facilitate immediate distribution of COVID-19 vaccines; these will adjudicate as brand medications.
Q. The CARES Act, after ACIP recommendations are announced, has indicated plans would have only 15 days to implement $0 coverage versus the normal one year. How will PBMs handle coding, client notifications, etc. in this timeframe?
A. PBMs are working with NCPDP to set up benefits and process claims under the pharmacy benefit that meet the NCPDP guidelines, which are published in the NCPDP Emergency Preparedness Guidelines. Clients will be able to set up benefits to meet their state or federal regulations.
Q. Are PBMs planning any type of routine member-oriented communications to educate members and help them make informed decisions?
A. Yes. Although procedures will vary slightly by PBMs, all will support clients and members with educational information about how to access the vaccine.
Q. Are PBMs doing anything to support adherence to the second vaccine dose (e.g., patient reminders, outreach, etc.)?
A. PBMs are exploring options to support member adherence to the second dose. In addition, some retail pharmacies are planning multi-pronged communications that include email, IVR, and text messaging to remind members about their second dose appointments.
Q. Will COVID vaccines be rebate-eligible? Are there pharma rebates provided for these medications?
A. No. Consistent with current vaccine strategy, COVID-19 vaccines are not rebate eligible and are not included in the calculation of rebate guarantees.
Q. Will the vaccines be approved for everyone or just select groups? Who will be the first to get the vaccines?
A. The CDC is making COVID-19 vaccine allocation recommendations based upon input from its advisory committee, the Advisory Committee on Immunization Practices (ACIP), which is holding regular meetings to discuss the key criteria for prioritizing who should receive COVID-19 vaccines if the supply is limited. ACIP has issued recommendations for which groups should receive the vaccine during the initial phase when vaccine supply is expected to be limited.
ACIP Recommendations (as of December 19, 2020):
The ACIP has offered interim recommendations for COVID-19 vaccines produced by Pfizer and Moderna. Pfizer’s vaccine is recommended for use in persons age 16 and older for the prevention of COVID-19; Moderna’s vaccine is recommended for use in persons age 18 and older.
When a COVID-19 vaccine is authorized by the FDA and recommended by ACIP, health care personnel and residents of long-term care facilities should be offered vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a).
The vaccine has not been studied in pregnant women or children. Children <18 years were purposely excluded from initial clinical trials to date. This is typically the standard protocol for vaccine development until safety and efficacy can be adequately assessed in adults first. However, more will be known when a vaccine has been authorized by the FDA for use and the ACIP has had a chance to review the available information and make a recommendation about vaccinating these populations.
ACIP will make additional recommendations once other vaccines are authorized for use by the FDA.
Q. Where will the vaccines be administered and will there be optimal locations for the different vaccines? Are there challenges with cold storage/distribution of the Pfizer vaccine? Will the Moderna vaccine have these same challenges?
A. The federal government has indicated allocations will be determined based on the provider’s:
(1) size and reach,
(2) capability to store vaccines and ensure cold chain management,
(3) ability to meet data reporting requirements to jurisdictions and the CDC, and
(4) estimated daily number of doses each facility is able to administer.
Pharmacies may also register to receive vaccines through their local jurisdictions.
The Pfizer vaccine is being distributed by Pfizer itself without a wholesaler due to the cold-chain shipping storage requirements necessary to preserve the vaccine, which requires extreme cold temperatures.
Likely the Pfizer vaccine will be administered within certain health care facilities (including long-term care facilities) with the ability to vaccinate large numbers of individuals quickly, due to the storage requirements.
The Moderna vaccine remains stable at refrigerated conditions, which allows for storage at most pharmacies in addition to hospitals and physicians’ offices. If approved, Moderna plans to distribute the vaccines via McKesson, the federally contracted distributor.
Q. Will the government be tracking who gets the vaccine?
A. Yes. The CDC and local jurisdictions have already highlighted the reporting requirements for vaccine providers in the Operation Warp Speed Playbook.
Administration at Pharmacies
Q. When do we anticipate retail pharmacies will begin to access and administer vaccines?
A. At this time, it is not precisely known when retail pharmacies will be able to administer vaccines in store locations in line with the prioritized group / early vaccination phased approach. RxBenefits will continue to monitor federal guidance and work with PBMs for updates on in-store availability.
Q. Are all network chains prepared to administer vaccines? What about independent pharmacies?
A. While all network pharmacies and independent pharmacies will be able to administer the vaccine, pharmacies will make their own determination on whether they will do so. If they choose to administer, they must enroll in the federal COVID-19 Vaccination Program.
Q. Do we know which retail chains are planning on stocking which vaccines? Do we anticipate all chains to be enrolled?
A. At this time, we don’t know which vaccine will be received through the initial phase of vaccine distribution in partnership with the federal government.
Per an 11.12.20 press release from the Department of Health and Human Services (HHS), the following pharmacy providers and pharmacy provider networks have signed on to participate in the federal allocation program:
- Albertsons Companies, Inc. (includes Osco, Jewel-Osco, Albertsons, Albertsons Market, Safeway, Tom Thumb, Star Market, Shaws, Haggen, Acme, Randalls, Carrs, Market Street, United, Vons, Pavilions, Amigos, Lucky’s, Pak n Save, Sav-On)
- Costco Wholesale Corp.
- CPESN USA, LLC
- CVS Pharmacy, Inc. (includes Long’s)
- Good Neighbor Pharmacy and AmerisourceBergen Drug Corporation’s PSAO, Elevate Provider
- Health Mart Systems, Inc.
- H-E- B, LP
- Hy-Vee, Inc.
- LeaderNET and Medicine Shoppe, Cardinal Health’s PSAOs
- Managed Health Care Associates (MHA)
- Meijer Inc.
- Publix Super Markets, Inc.
- Retail Business Services, LLC (includes Food Lion, Giant Food, The Giant Company, Hannaford Bros Co, Stop & Shop)
- Rite Aid Corp.
- The Kroger Co. (includes Kroger, Harris Teeter, Fred Meyer, Frys, Ralphs, King Soopers, Smiths, City Market, Dillons, Marianos, Pick-n-Save, Copps, Metro Market)
- Topco Associates, LLC (includes Big-Y Pharmacy and Wellness Center, Brookshire’s Pharmacy, Super One Pharmacy, FRESH by Brookshire’s Pharmacy, Coborn’s Pharmacy, Cash Wise Pharmacy, MarketPlace Pharmacy, Hartig Drug Company, King Kullen, Food City Pharmacy, Ingles Pharmacy, Raley’s, Bel Air, Nob Hill Pharmacies, Save Mart Pharmacies, Lucky Pharmacies, SpartanNash, Price Chopper, Market 32, Tops Friendly Markets, ShopRite, Wegmans, Weis Markets, Acme Fresh Markets)
- Walgreens (includes Duane Reade)
- Walmart, Inc. (includes Sam’s Club)
- Winn-Dixie Stores Inc. (includes Winn-Dixie, Harveys, Fresco Y Mas)
Q. Will each state’s board of pharmacy determine if a pharmacist can administer the COVID-19 vaccine? Do pharmacists have to be specially trained and certified to administer vaccines? Can pharmacy technicians administer vaccines?
A. The HHS has provided authority for pharmacists to order and administer COVID-19 vaccines during the Emergency Period and allows interns and technicians, with acceptable credentialing, to administer vaccines under the authority of a pharmacist.
To administer COVID-19 vaccines, providers must enroll in the federal COVID-19 Vaccination Program coordinated through their jurisdiction’s immunization program. Each state jurisdiction will provide credentialing requirements for immunizers and during the Emergency Period only enrolled immunizers will have access to COVID-19 vaccines. The program requires daily reporting of vaccine administration activities to the CDC and the local jurisdiction managing the vaccine distributions and allocations.
Q. Will members be able to obtain the vaccine at out-of-network pharmacies?
A. Yes, members will be able to obtain the vaccine at both in-network and out-of-network pharmacies. This is federally mandated.
Consumer Information / Reaction
Q. Can you explain “vaccine hesitancy”?
A. Vaccine hesitancy refers to a person’s delay in acceptance or refusal of vaccination despite availability of vaccination services. Despite the toll COVID-19 has taken, many people in the U.S. are concerned about a vaccine.
A nationwide survey of 5,153 people was conducted by CVS Health November 10-15. The survey showed:
- 28% were interested in receiving a vaccine as soon as it was available
- 35% would wait until others had been vaccinated
- 20% were uncertain about receiving a vaccine
- 17% did not plan to be vaccinated
A rough breakdown of demographic data showed:
- Men are more likely to be vaccinated than women
- College-educated people are more likely to be vaccinated
- Higher-income people are more likely to be vaccinated
- Urban dwellers are more likely to be vaccinated
- Those living in the Midwest and West are more likely to be vaccinated
- People over 55 are more likely to be vaccinated
- People managing a chronic condition are more likely to be vaccinated
- People who have been tested for the virus are more likely to be vaccinated
Q. What are the reasons for vaccine hesitancy?
A. Based on the CVS Health survey of November 10-15, some key factors cited by those who expressed concern about the vaccine included:
- The vaccine creation process seems rushed
- Needing to be convinced it works / not sure of its effectiveness
- Afraid of side effects / long-term effects
- Don’t believe it’s safe
- Politics / propoganda
Q. What are the benefits of the flu vaccine during the pandemic?
A. It’s important to stay vigilant against other illnesses like influenza, also known as the flu, which has similar symptoms to COVID-19. The CDC recommends all persons aged ≥6 months who do not have contraindications get the flu vaccine, which is covered under your current vaccine program. Although the flu vaccine does NOT provide protection against COVID-19, protection against the flu may help health care professionals potentially rule out a flu diagnosis when examining patient symptoms. There is some associative data showing potentially a mild protective effect against COVID-19 for individuals who take the conventional flu vaccine.
Q. If Pfizer and Moderna vaccines are cleared by the FDA via EUA in December, what type of supply do we anticipate relative to their production and supply to U.S. citizens in the first quarter of 2021 and beyond?
A. Pfizer said they will be able to provide 40 million doses by the end of 2020. The U.S. government has an agreement for 100 million doses of Pfizer’s vaccine with an option to purchase 500 million more. Similarly, Moderna has an agreement with the U.S. government to supply 100 million doses, with 20 million doses available by the end of 2020.
The U.S. expects to have enough Pfizer and Moderna doses to vaccinate 20 million Americans in December and 25 million more in January, per STAT. Moderna said it is on track to produce 500 million to a billion doses of the two-dose vaccine in 2021.
With over 300 million individuals in the U.S., and each vaccine requiring two doses, such a limited initial supply will need to be prioritized until the manufacturing capabilities can ramp up and other vaccines gain approval to meet the demand of the entire population.
Q. Will the supplies produced by these companies only be available to those in the U.S., or will they be allocated worldwide?
A. Supplies produced by these manufacturers will be made available to countries around the world. The United States, several European countries, and others have already placed sizeable advance orders for vaccine, and the World Health Organization (WHO) has established the COVID-19 Vaccines Global Access (COVAX) Facility to try and ensure equitable distribution of vaccine to all countries, rich and poor.
Q. Do we anticipate there will be enough supply of vaccine to properly vaccinate everyone in the U.S.? If so, by when?
A. The initial supply as indicated by Pfizer and Moderna will not be enough to vaccinate everyone in the U.S. Distribution will need to be prioritized for those most in need until manufacturing capabilities can ramp up and additional manufacturer vaccines are approved to meet the demand of the entire population.
Early in the response, the federal government began investing in select vaccine manufacturers to help them increase their ability to quickly make and distribute a large amount of COVID-19 vaccine. This will allow the United States to start with as much vaccine as possible and continually increase the supply in the weeks and months to follow. The goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available. Several thousand vaccination providers will be available, including doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers.
Q. Will there be quantity limits or age edits applied to these vaccines to manage supply?
A. Quantity limits will be implemented to prevent more than the recommended number of doses being administered based on the EUA. Age limits are being considered to ensure appropriate use in teh defined age group stated in the EUA.
Cost / Benefit Administration
Q. What is the cost of the vaccine to plan sponsors? Will all vaccine costs be covered by the federal government?
A. At this time the federal government will cover the cost of the COVID-19 vaccine through funding authorized by the Coronavirus Aid, Relief, and Economic Security (CARES) Act. We are not able to speculate for how long.
Medicare will cover the costs and administration fees through the Medicare Fee-For-Service (FFS) program until the Medicare Advantage (MA) capitation rates take the new significant cost into account. Contracted providers should be directed to submit claims for administration of the COVID-19 vaccine to the CMS Medicare Administrative Contractor (MAC) for payment.
Fully insured and self-insured plans will be required to pay for the administration of the vaccine.
Q. What is the anticipated cost for the vaccine administration?
A. Administration costs for the vaccine are as follows:
- Administration cost for two doses: first dose $16.94 / second dose $28.39
- Administration cost for a single dose: $28.39
Fully insured and self-insured plans will be required to pay for the administration of the vaccine. Administration fees for Medicare plans will be covered by Medicare FFS.
Q. What will the member cost-share be? Is this set by HHS or can plan sponsors set the member cost-share?
A. As established in the CARES Act, patients will receive the vaccine at no out-of-pocket cost and no deductible regardless of where they get the vaccine. State Medicaid and CHIP agencies must provide COVID-19 vaccinations at no cost-sharing for beneficiaries and CMS is requiring that private health plans and insurers cover the COVID-19 vaccine administration with no cost-sharing as outlined below.
Q. Will vaccines be covered under Medicare Part D?
A. Medicare guidance has stated the Part B FFS benefit administered by the federal government will be the primary coverage channel for COVID-19 vaccines. Though MA organizations are not excluded from covering the product, the capitation payments that these organizations receive will not include funding for COVID-19 vaccines until the end of 2021. The guidance encourages MA organizations to coordinate with their local providers to confirm their readiness to issue vaccines under the FFS program.
Employer Group Waiver Plans (EGWPs) are able to allow coverage for the administration fees, but would incur additional financial risk.
Q. Is coverage of the vaccine administered under the medical benefit or pharmacy benefit?
A. The COVID-19 vaccine will be managed in a similar manner to other preventative vaccines.
In general, clients can choose to cover the administration cost through their medical and/or PBM pharmacy benefit.
However, given the recent HHS announcement of federal government partnership with large pharmacy chains and community pharmacies to access and administer the vaccines as they become available, RxBenefits recommends clients cover the COVID-19 vaccine and its associated administration fee under the PBM pharmacy benefit to offer members easy access. Clients should also consider coverage under the medical benefit when doctors have access to the serum and offer it as part of an office visit.
Medicare: Coverage for the COVID-19 vaccine for plans with Part D will be administered under Medicare Part B under the medical benefit. Medicare guidance has stated the Part B FFS benefit administered by the federal government will be the primary coverage channel for COVID-19 vaccines. Though MA organizations are not excluded from covering the product, the capitation payments that these organizations receive will not include funding for COVID-19 vaccines until the end of 2021. The guidance encourages MA organizations to coordinate with their local providers to confirm their readiness to issue vaccines under the FFS program.
Medicaid: The Centers for Medicare and Medicaid Services (CMS) has mandated states must cover COVID-19 vaccine administration fees with a $0 cost-share. CMS recommends alignment to CMS reimbursements; however, state agencies have not yet advised how they will cover this benefit or their reimbursement strategy.
Q. If a member receives a COVID-19 vaccination at a doctor’s office, would it still be paid under the pharmacy benefit?
A. Like coverage for any vaccine, we recommend coverage under both the medical and pharmacy benefit. This allows ultimate convenience for the member. There isn’t much risk for double-dipping with vaccines.
Based on the expected vaccine distribution system via retail pharmacies, it makes sense to cover it under the pharmacy benefit. This will provide more immediate access for the member, rather than needing to schedule an office visit.
For CVS and OptumRx clients, their plans will be updated to provide coverage under the pharmacy benefit. For ESI clients who are enrolled in their vaccination network offering, they will be automatically updated. For those who are not, we will be approaching them with an enrollment opportunity in January.