Here is FDA’s decision that allows undiluted frozen vials of the Pfizer-vaccine to be moved and stored at normal freezer temperatures for up to two weeks. Previously, the Pfizer vaccine had to be held at an  ultra-low temperature freezer (-80ºC to -60ºC). The FDA updated their Fact Sheet for Healthcare Providers Administering Vaccine to reflect this change.

This newfound storage and handling requirement makes the Pfizer vaccine perfect for community vaccination sites- and makes additional vaccination mega-sites less attractive as a way to get vaccine to the people.

Two big developments this week have turned the tables on the more efficient way to get folks vaccinated. The FDA is now allowing the Pfizer vaccine to be stored at normal freezer temperatures (just like Moderna) and we now have the Johnson & Johnson vaccine which is uber-flexible and requires just refrigerator storage temps.

With these new developments, the most efficient way to get folks vaccinated is to decentralize vaccine allocations toward clinics, community health centers pharmacies, and primary care offices. That means we need to prioritize vaccine allocations toward community vaccinators and away from any additional (or expanding current) mega-sites.

At the beginning of the COVID vaccination effort, it made some sense to set up mega-sites. That’s because the Pfizer vaccine lended itself to mass-vax sites because of the restrictive cold-holding temperature requirements and the fact that employment groups like healthcare workers and teachers were prioritized.

Last week’s 2 big developments re J&J and Pfizer have turned the tables. 

At first blush, vaccination mega-sites might seem like a logical and efficient solution to vaccinating large numbers of people. They make for dramatic television footage and look impressive. But are they really the most efficient way to get vaccine out?  Not any more.

Look at it this way… there are about 1,500 pharmacies in Arizona, most located a short distance from people’s homes. Let’s say we could get 1,000 of them to participate in COVID vaccinations now that all 3 of the vaccines are so much more flexible to store and use.

Imagine for a moment that each pharmacy can vaccinate 50 people per day (not a big ask). That equals a capacity to vaccinate 50,000 people per day or 350,000 vaccinations per week – all happening near people’s homes.

Compare that to state government’s flagship mega-site which is vaccinating about 6,000 people per day. Even if they could really expand to 10,000 per day, why would you prioritize allocation of vaccine to more mega-sites where people need to book appointments on a complex website with limited slots when you could instead prioritize the vaccine to thousands of pharmacies, clinics and doctors offices.

The short answer is that the state government has established a brand at the mass vaccination sites that they see as helping their image. I expect them to continue to prioritize vaccine allocations toward the mega-sites at the expense of community vaccinators like clinics and pharmacies because the mega sites get favorable press coverage.

However, if state government would take a cold hard look at what’s most efficient, they would see that prioritizing vaccine toward  pharmacies and clinics is actually the best way to go.

Fortunately, the federal government recognizes the value in getting vaccine directly to pharmacies and community health centers with the implementation of their federal pharmacy and FQHC direct shipment systems.

See our blog post entitled Federal Pharmacy Program Making Significant Inroads Toward Vaccine Access

A few weeks ago the Biden Administration announced an initiative to increase vaccine supply in states through the new Federal Retail Pharmacy Program.

Last week the program kicked off with the direct distribution of vaccine to about 200 pharmacies in Arizona. AZ pharmacies around the state received an average of 100 doses of vaccine through the program. All of the vaccine is Moderna.

The participating pharmacies in AZ are Safeway, Fry’s and Walgreens. I also saw that some appointments will be available at a few Albertsons. The program will be expanded in subsequent weeks will be based on vaccine availability. The goal is to include more than 40,000 locations nationwide (that would be about 800 pharmacies in AZ- or about ½ of all AZ pharmacies).

Here’s a link to the Maricopa County Department of Public Health website where you can look for appointments.

Importantly, the vaccine is distributed directly from the federal government to the participating pharmacies. This is important because it prevents state health departments from diverting the vaccine to other priorities that they may have like state-run vaccination sites.

It’s critical that we diversify the ways in which people can find vaccine because the current one-size-fits-all allocation and distribution system does not serve lower income communities well.  See last week’s blog post to get an idea of the health disparities that are emerging.

The federal pharmacy program provides a direct way of building far more access points while giving people an alternative to state allocation schemes that provide advantages to wealthier persons.

FQHC Distribution Programs Announced

The Biden Administration has also announced another new federal program whereby the federal government will directly distribute to Federally Qualified Health Centers.

This is also a terrific new program because it will directly allocate vaccine to FQHCs who focus their services on rural and underserved areas, precisely the folks that are at a disadvantage right now getting appointments through the ADHS system.  Importantly, appointments for vaccine at FQHCs can be made without going through the convoluted ADHS appointment website.

The federal pharmacy and FQHC programs will become increasingly significant when the Johnson & Johnson vaccine is authorized next weekend. The J&J vaccine is perfect for pharmacies to use. Storage and handling for that vaccine is just like most other vaccines.

The FDA committee is meeting on February 26 to consider the J&J emergency use application. I expect authorization to happen by March 1 with shipments starting March 2. Hopefully the destination for many if not most of the J&J vaccines will be through this new federal pharmacy program.

CNN is reporting that “… a J&J official stated that the company currently has less than 10M doses manufactured and available for distribution in the US”. This is a disappointing number as it amounts to about 200,000 doses for Arizona. At least this is a single dose vaccine so it’s equivalent to 400,000 doses of Moderna or Pfizer.

Editorial Note: The Association for State and Territorial Health Officials sent a letter to the President urging him to better coordinate the allocation of vaccine through the FQHC and retail pharmacy programs. Thankfully, the letter stops short of urging the federal government to relinquish control of these programs to governors and state health directors…  but the letter goes right up to that edge.

We have seen and continue to see, first-hand, that governors and state health directors often allocate vaccine toward their preferred sites (e.g. State Farm) that aren’t focused on providing vaccine to underserved areas.

If the federal government were to hand over allocation control to state health directors and their governors, we can expect to see vaccine that is intended for local pharmacies and Federally Qualified Health Centers get diverted to pet high-profile vaccination sites that are not focused on helping low-income communities.

With FDA Authorization, Some Limited Deliveries Could Start Monday or Tuesday

A few weeks ago Johnson & Johnson applied for emergency use authorization of their candidate vaccine. The FDA’s review committee is meeting Friday morning. The FDA just posted all the data on their website.  There are several documents in the meeting packet but the one that I like to look at is the FDA’s briefing document to the committee.

I didn’t see any surprises in todays reports. The results from the Phase III clinical trial look good (about 43,000 participants in the trial).  Here’s the bottom-line effectiveness (from the summary report):

“…  vaccine efficacy against central laboratory confirmed and blind-adjudicated severe/critical COVID-19 occurring at least 14 days and at least 28 days after vaccination of 76.7% and 85.4% respectively.”

In other words, this single dose vaccine is 77% effective at preventing severe COVID disease 14-days after the jab and 85% effective after 28 days.

There were 2 hospitalizations from COVID in the vaccine group (both before 28 days post vaccination) compared with 29 cases in the placebo (saltwater injection) group.  None of the persons that were given the vaccine died while 7 people died of COVID in the placebo group.

The vaccine worked equally among subgroups in the trial (age, comorbidity, race, ethnicity) but effectiveness among folks 60 years of age and older with comorbidities was a little lower early on in the study (i.e., counting cases from 14 days rather than 28 days and including cases not yet centrally confirmed).

Side effects within 7 days of injection were the statistically the same among the vaccine and placebo (saltwater) groups. In other words, side effects were no different whether the person got the vaccine or the saltwater injection.  Those side effects included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), and myalgia (33.2%).

The independent review committee concluded that:

“… the analysis supported a favorable safety profile with no specific safety concerns identified that would preclude issuance of an EUA”.

The bottom line is that this vaccine is very likely to be authorized for use in the U.S. as early as Monday. Shipments to states will likely start on March 2. I’ve had a really hard time pinning down exactly how much vaccine is actually available and ready for distribution in the U.S. The best info I could find is from a media report in the Washington Post quoting 2 anonymous FDA officials that said there are about 2 million doses available right now and that the supply of this vaccine will be 20 million by the end of March.

If true, that’s pretty disappointing because 2 million doses nationally translates into only 40,000 doses for Arizona right now. If they can really ramp up to 20 million doses by the end March that will be better. That would translate into 400,000 doses but is the equivalent to 800,000 doses of the Pfizer or Moderna vaccines because J&J doesn’t require the booster shot.

The Friday, Feb. 26 at 7 a.m. AZ time FDA Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee meeting will be online.

• The agenda can be found here.

• FDA’s Briefing Document – Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19 – can be found here.

• Janssen Biotech Inc. Briefing Document Addendum can be found here.

• The live meeting will be available here and here.

The online web conference meeting will be available at the following: 

• https://youtu.be/Qd7mlCD-rEAExternal Link Disclaimer

• https://fda.yorkcast.com/webcast/Play/3098af8852e64bc79930bdaa1001d3af1

Note: Globally and in the U.S. this is a very important vaccine. It is simple, inexpensive, doesn’t require complicated storage and handling, and (perhaps most importantly) is a single dose vaccine. This vaccine belongs in doctor’s offices, pharmacies, and community health centers. Using it at mass vaccination sites would be a big mistake because one of this vaccine’s strengths is its flexibility. This vaccine’s flexibility means that we can bring the vaccine to the people rather than bringing the people to the vaccine… which can help us overcome the large disparities that exist in Arizona: ADHS Vaccine Appointment System Favors the Wealthy & Creates Health Disparities

In the U.S., it will be a terrific addition to our current vaccines because it’s perfect for doctor’s offices and pharmacies. Because it’s single dose, it will be a lot less labor intensive. In developing nations, it would be a game changes for the same reasons and because it is inexpensive to make.