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.

One of the main things that scares people that are vaccine hesitant is the fear that they might get an allergic reaction to the vaccine.  We know that allergic reactions were super-rare in the clinical trials  (each of which followed about 30,000 people). Now that the Pfizer and Moderna vaccines have been deployed – we have even more data demonstrating that allergic reactions are extremely rare.

More than 4,000,000 vaccines have been given in the community now (100x times more people than a clinical trial), greatly expanding our knowledge about the safety of the vaccines.  The CDC will be publishing reports on what has been happening in the field regarding vaccine safety from time to time.

Last Thursday CDC published in new MMWR entitled: Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Moderna COVID-19 Vaccine: December 21, 2020–January 10, 2021

The report found, as expected, that so far allergic reactions to the vaccines have been exceedingly rare. Between December 21, 2020 and January 10, 2021 there had been 10 allergic reactions to the vaccine among the more than 4,000,000 people that have received a dose. That’s equal to 2.5 cases per million doses.  In 9 of the 10 cases the reaction happened within 15 minutes of vaccination. No anaphylaxis-related deaths were reported.

This week saw a meaningful decline in Covid-19 cases which now clearly represents a real decrease in viral transmission. This decline is accompanied by reductions in hospital and ICU occupancy. Reductions in mortality should follow. While this reprieve is welcomed, the absolute level of SARS-CoV-2 virus transmission remains exceptionally high.

As of January 24th, new cases were being diagnosed at a rate of 557 cases per 100,000 residents per week. This rate was declining by 150 cases per 100,000 residents per week. Despite this improvement, no other state is experiencing faster transmission than Arizona according to the CDC. Because of this, Arizona has moved up 2 positions to the 6th hardest hit state since the outbreak began.

Arizona is reporting >800 Covid-19 deaths per week (>115 per day) and this count may underestimate true fatalities by half (see Woolf, Woolf, or Weinberger). Many of these deaths were preventable if the state had more aggressively adopted evidenced-based public health practices. Arizona’s weekly tally of deaths now ranks second in the nation. Overall, we rank 10th.

The Arizona Public Health Association released a report on all-cause mortality during the Covid-19 pandemic. The main finding is that all-cause mortality was 23% higher in 2020 than 2019 with the months of July and December being outliers with 64% and 61% higher mortality, respectively. This translates into approximately 15,000 excess deaths.

The Arizona Public Health Association also released a report that describes the chronological course of the Covid-19 outbreak in Arizona and chronicles the state’s response or lack thereof. 

Hospital Covid-19 occupancy is declining in the ward and ICU. However, access to care for Covid-19 and non-Covid patients remains restricted in ways that are difficult to understand owing to changes in care practices.

Hospitals continue to postpone many scheduled procedures to create additional capacity for Covid-19 patients at the expense of others with serious medical conditions.

Health professionals are being asked to work additional hours and assume duties outside their traditional scope of practice.

The test positivity rate for traditional nasopharyngeal PCR testing declined for the third straight week, dropping from a peak of 35% to 29% this past week. Nevertheless, our testing capacity is wholly inadequate to the scale of the problem and other regions.

So far, 1110 per 100,000 (1.1%) Arizona residents have received at least 2-doses of vaccine while 6044 per 100,000 (6.0%) have received at least 1-dose. Arizona vaccination roll-out places us in the bottom half of US states. To date, Arizona has administered only about one-half of its delivered doses

Here is the full weekly report, which includes all of the informative graphs.

Good question.

There are a lot of people that aren’t able to schedule the SARS CoV2 booster shot these days. Whether it’s because the ADHS website still isn’t working properly or because not enough appointments or doses have been reserved by the ADHS for the required 2nd dose (or a combination thereof)… a lot of people are asking themselves “how much protection did that first dose give me in case can’t find a the booster shot I need in the next few weeks or even months”?

There is good and bad news. The good news is that the first does provide some protection from infection but nothing close to the level or protection you get if you are one of the lucky people that have been able to schedule your 2nd dose.

According to the data published about Pfizer’s Phase III Clinical Trial data in the New England Journal of Medicine, people that just get the 1st shot probably have about 50% protection from being infected with the virus starting about 2 weeks after the first jab.

Here’s the exact quote from the Phase III trial write up in NEJM “…  between the first dose and the second dose, 39 cases in the BNT162b2 group and 82 cases in the placebo group were observed, resulting in a vaccine efficacy of 52% (95% CI, 29.5 to 68.4) during this interval and indicating early protection by the vaccine, starting as soon as 12 days after the first dose”.

Intuitively, one would expect that a person that just had one dose might have more than 50% protection from severe COVID-19 disease. That may be the case. Here’s what the NEJM article said about that “… among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient”. In other words, your protection from severe disease is probably higher than the 52% protection figure but there aren’t enough data to be definitive about that.

The Pfizer Phase III clinical trial was not designed to assess the efficacy of a single-dose regimen. Nevertheless, the study concluded that “… in the interval between the first and second doses, the observed vaccine efficacy against Covid-19 was 52%.  Of the 10 cases of severe Covid-19 that were observed after the first dose, only 1 occurred in the vaccine group. This finding is consistent with overall high efficacy against all Covid-19 cases. The severe case split provides preliminary evidence of vaccine mediated protection against severe disease, alleviating many of the theoretical concerns over vaccine-mediated disease enhancement.”

The bottom line is that if you aren’t able to find an appointment for a booster shot at least you know you have about 50% protection from infection and more than 50% protection from getting severe COVID disease.

Side Note: Director Christ has been suggesting in the media that it is fine to get your booster shot after the 21-day interval for Pfizer and the 28-day interval for Moderna. That may very well be true, but there are no data in the Phase III clinical trials to support the idea that you will emerge from the series with the 95% suggested in the clinical trials.  I could find no data to suggest that end-point immunity is the same 95% if the interval between vaccines is extended beyond the 21 and 28-day intervals researched in the clinical trials.