UK Temporarily Authorizes Use of the Oxford/AstraZeneca Vaccine

Last Wednesday the UK’s Department of Health & Social Care and their Medicines and Healthcare Products Regulatory Agency temporarily authorized the AstraZeneca/Oxford vaccine. Here is their clinician information packet with some of the particulars

Here’s the short summary of the safety profile:

“The most frequently reported adverse reactions were injection site tenderness (>60%); injection site pain, headache, fatigue (>50%); myalgia, malaise (>40%); pyrexia, chills (>30%); and arthralgia, nausea (>20%). The majority of adverse reactions were mild to moderate in severity and usually resolved within a few days of vaccination. By day 7 the incidence of subjects with at least one local or systemic reaction was 4% and 13% respectively. When compared with the first dose, adverse reactions reported after the second dose were milder and reported less frequently.  Adverse reactions were generally milder and reported less frequently in older adults (≥65 years old).”

Here’s the short summary of the efficacy profile:

“In this population, vaccine efficacy from 22 days post dose 1 was 73.00% (95% CI: 48.79; 85.76 [COVID-19 Vaccine AstraZeneca 12/7,998 vs control 44/7,982]).  Following vaccination with COVID-19 Vaccine AstraZeneca, in participants who were seronegative at baseline, seroconversion (as measured by a ≥4 fold increase from baseline in S binding antibodies) was demonstrated in ≥98% of participants at 28 days after the first dose and >99% at 28 days after the second.” 

This is a more traditional vaccine when compared to the Pfizer and Moderna vaccines. This one uses an adenovirus vector to develop the immune response, while Pfizer and Moderna use a new mRNA technology.

Importantly, this vaccine is supposed to be stored at regular refrigerator temperatures, has a 6-month shelf-life, and can be stored between 2°C and 25°C during the in-use period. These characteristics make the vaccine far more flexible and easier to use in a much wider range of settings.  It will be particularly valuable for developing nations with limited infrastructure.

Back in May,  HHS announced that they had contracted with AstraZeneca providing $1.2B to support the development of their candidate vaccine (which has been developed in conjunction with the University of Oxford). The agreement is to make available at least 300 million doses of the vaccine for the United States. 

I couldn’t find info on how many doses have already been manufactured that may be available in the U.S. when the vaccine is ultimately given Emergency Use Authorization (most likely in January).

ADHS Director Scraps COVID-19 Spread Metrics for Business Operations

Substantial Spread Effectively No Longer Exists as a Category for Informing Interventions

Over the summer a host of stakeholders including the business community developed COVID-19 metrics to inform policy decisions like when it’s time to impose additional operational restrictions on bars and restaurants. Shortly after the ideas were presented to the Governor’s Office, the ADHS adopted the metrics and highlighted them as a key tool for driving future intervention decisions.

The metrics were then used when the state decided to lift the limitations put on bars, restaurants and gyms during the summer “pause”.

The protocol was scrapped in mid-December to ensure that the state metrics never suggest additional operational restrictions are needed at bars and restaurants no matter how bad community spread gets.

Here’s a story from the Health Arizona Daily Star that describes the decision by Dr. Christ to scrap the business metrics and her rationale for doing so.

Under the former criteria, bars and in-person dining are not allowed to operate when a county is in the ‘Substantial’ category.

As community spread began to increase in late October and into November & December, county after county moved into the Substantial spread category. When asked why the ADHS was not advocating for enhanced interventions because of the substantial spread, Dr. Christ (the agency director) said that while the metrics and protocol were valuable for deciding when to open businesses, they weren’t useful for deciding when to close them or to impose additional operational restrictions.

As that argument became increasingly untenable, the agency changed the standards governing business operations such that it’s impossible to reach a threshold in which community spread is high enough to warrant enhanced interventions on bars and restaurants no matter how serious the infection rate gets. Basically, Substantial Spread has been eliminated as a category.

Initial Vaccination Efforts Complicated by Glitchy ADHS Computer System

Less than 18% of the COVID19 vaccines that have been delivered in Arizona had been used as of 12/31. Clearly something is amiss, but what?

It turns out that one of the core reasons for the slow use of vaccines had to do with an ADHS computer software system. It was supposed to efficiently make vaccination appointments and provide billing information among other things. It’s built into the ADHS’ Vaccine Management System (VMS).

It’s a long story, but glitches in the ADHS’ VMS scheduling software failed to make appointments for thousands of healthcare workers that had pre-registered for vaccination. Many received no information at all back from the ADHS system. Others were instructed to go to Show Low, Globe or Snowflake for their vaccine even though they live in Maricopa County.

As a result, two of the five mass vaccination sites in Maricopa County were largely empty for many days in December. The glitches have apparently been corrected as of this weekend.

It’s a long story, but if you want to read more, check out this story by Ray Stern in the Phoenix New Times:  Arizona Vaccine Rollout Delayed by Computer Glitches, County Says.

New COVID Vaccine Executive Order Issued

Last week the Governor issued an Executive Order that he said is designed to make vaccination efforts more streamlined. The Executive Order says that the ADHS is supposed to use a statewide “vaccine allocation model”, can reallocate vaccine, and must approve all private vaccination sites. It also requires counties to post their vaccination progress and vaccination sites on their websites.

The Order doesn’t give the ADHS any authority that it doesn’t already have, but it does provide some direction and expectations to the Department.

Here’s where you can look it over. Honestly, it doesn’t look substantive to me.