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Johnson & Johnson applied for Emergency Use Authorization (EUA) for their candidate vaccine last Thursday. Their candidate is a single dose vaccine that uses a weakened cold virus as the vehicle for the antigen that stimulates the immune response.

The FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request. They will likely make a recommendation whether to authorize or not during that meeting. The FDA Commissioner will then likely make a decision shortly thereafter.

Note: Former FDA Commissioner Hahn resigned and has been replaced by Acting Commissioner Janet Woodcock M.D. Dr. Woodcock is a Career FDA professional – having served at the FDA since 1984.

The company says they have vaccine immediately ready for shipment as soon as the FDA authorizes emergency use of the vaccine. The FDA hasn’t posted the application data on their website yet, but I’ll keep an eye out for it.

An NIH and J&J press release (not the full published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

Both the NIH and J&J have stated that their vaccine candidate: 

“… is 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”

Novavax also announced (but did not publish) encouraging results of their Phase III Clinical Trial. Their press release (not published data) said that their clinical trial met the primary endpoints for safety and effectiveness. They said that upcoming results will show that their vaccine candidate was 89% effective in the Phase III clinical trial conducted in the UK.

“With today’s results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants.”

“In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants,” (from Stanley Erck, President and CEO of Novavax.

No word on when the trial data will be published nor when they will ask the FDA for emergency use authorization. This is also an important vaccine as it too has simple storage and handling requirements and is perfect for doctor’s offices, pharmacies, mobile clinics and community health centers.

There was some drama yesterday about how much vaccine has been “wasted” at various Maricopa County mass vaccination sites.  Journalists submitted public records requests to Maricopa County Department of Public Health and the ADHS asking for data about how many doses of vaccine were unusable at the various PODs. Maricopa County produced the data, sharing that a total of 553 doses out of 153,196 administered have been discarded at county PODs between December 17, 2020 and Jan. 20, 2021.

This represents 0.3% or 3 of every 1,000 doses that have been administered through these PODs to that date. For perspective, standard wastage for all vaccines in doctors’ and pediatric offices is between 3% and 5%.

I did a few interviews on the issue of accidents and problems that can happen when administering vaccinations including this one from FOX10 saying that a 0.3% wastage rate is a testament to good performance at the PODs. By comparison, wastage rates at pediatric offices are typically between 3-5%.

The drama came when Governor Ducey tweeted the following statement:

“The COVID19 vaccine is a precious and limited resource – that any doses would be wasted is shocking and unacceptable. This has not and will not happen at any state-run sites, and local leaders must prevent it from ever happening again at any county-run site.”

The statement that no problems have come up nor mistakes made at their branded State Farm POD is, of course, preposterous. There’s no way that a mass vaccination site like State Farm has never had an issue that led to a discarded vaccine.  ADHS has not disclosed how many vaccines have been discarded at State Farm, but I can guarantee you that it is not zero. I’m hopeful ADHS will be quick to respond to press inquiries about its own data about vaccine wastage.

The fact that a small number of issues may have come up at State Farm and some vaccines discarded isn’t the issue. The problem is a when the Governor makes a false statement disparaging the performance of a key partner (performance that is, in fact, good) when the state itself is unwilling to disclose its own performance on that same metric… and then fabricates a tale that no vaccine has ever been discarded.

If there is any concern about the quality of the vaccine or any information is not readable on the label, manufacturers have advised providers to throw out the vaccine to maintain a safe operation.  That can mean things like:

1) A vial does not have a readable label or expiration date and cannot be used;

2)  There is particulate matter or “floaters” present in the vial and all 5 doses are wasted;

3) A vial is partially filled and none of the contents can be used;

4) Equipment malfunction, such as a bent needle, recapping issues, or the plunger is depressed accidentally; and

5) Draw-up issues like having a bubble in the syringe or a needle stick injury or an error mixing the dose.

These are issues that occur any time vaccines are given, particularly during large volume operations (this is not an exhaustive list of ways that vaccine doses can be unusable). Any large vaccine administration site that claims that “no doses are wasted” is not operating safely or not being honest about wasted doses.

Persons in key elected and appointed positions should be honest and transparent with the people of Arizona. We deserve at least that.  

The data are still coming in, but so far it looks like the Pfizer and Moderna vaccines are close to equally protective for the new UK strain. It’s also looking like both vaccines are less effective against the south African strain because some of the mutations on that variant code for the protein coat (that’s the queue that the immune system uses to build antibodies, B cells and T cells (see our discussion of the immune system in these previous posts Part I and Part II). 

Because there is a wide margin of safety for the protective threshold of neutralizing antibody action against the virus- the vaccine is still protective of that strain as well (although at a lower level- perhaps 70% protective against infection or so).

A new study was published this week entitled mRNA Vaccine-elicited Antibodies to SARS-CoV-2 and Circulating Variants. You can read the study yourself, but basically they found that people who have been vaccinated had high antibody titer levels of IgM, and IgG that are highly effective at neutralizing the virus. Interestingly, it found no difference in the memory B cells when comparing people that were fully vaccinated compared to people with a natural infection.

They found that the UK (B1.1.7/501Y.V1), South Africa (501Y.V2) and Brazil (B1.1.28/501.V3) have a reduced antibody neutralization potency compared to the classic strain.  However, those differences had “comparatively modest” effects on viral sensitivity.

The study does forecast, however, that:

“it is possible that these mutations and others that emerge in individuals with suboptimal or waning immunity will erode the effectiveness of natural and vaccine elicited immunity. The data suggests that SARS-CoV-2 vaccines may need to be updated and immunity monitored in order to compensate for viral evolution.”

The Company is Expected to Apply for Emergency Use Authorization This Week

Johnson & Johnson announced (but have not published) encouraging results of their Phase III Clinical Trial. Their press release (not published data) said that their clinical trial of 43,783 participants “met all primary and key secondary endpoints”. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.

They say that their vaccine candidate: 

“… was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination.”

Here is the info from the full media release: Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial

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 important is a single dose vaccine. 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.