Friday, Feb. 5, 2021
No, I haven’t heard about mine yet, but a multitude of emails and Facebook posts tell me that many of my friends either have their appointment or even their first shot. As for me, I check the website daily. In the meantime, vaccine news continues to dominate the early months of 2021. Seldom have research results been so publicly available and so widely discussed.
The one-shot vaccine is on the track to approval today. Johnson & Johnson/Janssen has submitted an application to the FDA for an Emergency Use Authorization for its vaccine. The vaccine was tested in the United States, South Africa, South America, and Central America (Mexico and Columbia) and found to be 85% effective overall against severe disease and hospitalization after 28 days. I was impressed that its efficacy increased over time, with no severe cases of disease reported after day 49. If you want to see more stats on age and diversity than a news article provides, go to the press release under Sources below for more detail.
The need for only one shot and normal refrigerator storage will make Johnson & Johnson/Janssen’s vaccine much easier to distribute. But with first clinical trials done and the structure in place, they are now ask new questions. For example, what about using different doses in the one shot? Does it work better with two doses? I’m glad that they tested the one-shot regimen first though. It puts the first clinically tested one-shot vaccine out there for approval.
While Johnson & Johnson/Janssen checks out two doses, other studies are evaluating whether two-dose vaccines are effective after one dose. This research are coming out as preprint (not yet peer-reviewed) articles which have been widely covered in the news. For example:
- A study by Kings College and the University of East Anglia in MedRxiv looked at the efficacy of a single dose of Pfizer vaccine. Looking at vaccinations given in Israel, they found that one shot was 0% effective after 14 days, but 90% effective after 21 days. This supports the UK decision to give single doses to as many people as possible to reduce the viral spread more quickly.
- A preprint study in the Lancet looked at the efficacy of Astrazeneca’s vaccine given either as one dose or two doses widely-spaced. One dose was 76% effective against symptomatic COVID-19 for 90 days after vaccination. Efficacy was much higher, however, after the second dose.
- Another preprint article from MedRxiv tested healthcare workers and found that people who had already had COVID-19 may be protected with only one dose of the Pfizer or Moderna vaccines, because their immune systems have already been exposed to the virus.
- In another type of study, the UK is recruiting 800 volunteers over 50 who have received no vaccine as yet to receive their first and second shot from different manufacturers, Pfizer and Oxford/Astrazeneca. The goal is to provide flexibility in vaccine distribution and test whether one shot of each type might provide better protection. Some volunteers will receive the Pfizer vaccine first and some the Oxford.
So is it okay to just get one shot of a two-shot vaccine? For a detailed analysis of the pros and cons, see “How effective is a single vaccine dose against Covid-19?” from BBC Future below. Here’s my take on it: It’s ideal to get the vaccine according to the protocol that was tested in clinical trials. The second shot or “booster shot” always gives a big increase in efficacy. We don’t know if the immunity triggered by the first shot is as powerful. We don’t know how long it lasts. While limited research studies like the ones above can give us valuable information, they cannot compare with large-scale double-blind clinical trials which look at thousands of people selected to represent a diverse population by age, ethnicity, and preexisting conditions, tested on several continents, and tested against both the known virus and the newer strains.
If, however, we are in a race against time with faster-spreading variants, giving one dose to more people might be our best temporary option. This was the decision taken by the UK.
What about here in the U.S.? Experts disagree. Immunologist Dr. Anthony Fauci favors giving the vaccines as soon as possible, but sticking to the timetable for the second shot. That’s the way they were tested and the second shot gives you a lot more immunity. Epidemiologist, Dr. Michael Osterholm, on the other hand, leans on the side of immunizing as many people as possible now, before the more transmissible new strains have a chance to take over. Both emphasize that widespread replication causes new strains and give the virus more opportunity to evade our present vaccines. Both have good points.
It’s an executive decision at this point, which brings it into the political arena. And it’s a decision that may have to be changed down the line. Because of changed circumstances. New strains, new information, unforeseen consequences.
Science does not tell us what to do. Science gives us information. We decide, in the end, how to use it.
Recent News Articles:
“Johnson & Johnson Announces Submission of Application to the U.S. FDA for Emergency Use Authorization of its Investigational Single-Shot Janssen COVID-19 Vaccine Candidate,” Cision PR Newswire, Feb. 4, 2021. https://www.prnewswire.com/news-releases/johnson–johnson-announces-submission-of-application-to-the-us-fda-for-emergency-use-authorization-of-its-investigational-single-shot-janssen-covid-19-vaccine-candidate-301222768.html?tc=eml_cleartime
“Pfizer vaccine: Single dose ‘90 per cent effective after 21 days’,” Science Focus, Feb. 4, 2021. https://www.sciencefocus.com/news/pfizer-vaccine-single-dose-90-per-cent-effective-after-21-days/
“COVID-19 also attacks the pancreas; one vaccine dose may be enough for those previously infected,” Reuters, Feb. 3, 2021. https://www.reuters.com/article/us-health-coronavirus-science/covid-19-also-attacks-the-pancreas-one-vaccine-dose-may-be-enough-for-those-previously-infected-idUSKBN2A332Q
“How effective is a single vaccine dose against Covid-19?” BBC Future, Jan. 14, 2021. https://www.bbc.com/future/article/20210114-covid-19-how-effective-is-a-single-vaccine-dose
“There’s no need to delay second dose of Covid-19 vaccine so more can get the first, Fauci says,” CNN, Feb. 4, 2021. https://www.msn.com/en-us/health/medical/theres-no-need-to-delay-second-dose-of-covid-19-vaccine-so-more-can-get-the-first-fauci-says/ar-BB1dlqbh
“Top epidemiologist says Biden administration needs to focus on first vaccine doses,” NBC Meet the Press, Jan.31, 2021. https://www.nbcnews.com/politics/meet-the-press/top-epidemiologist-says-biden-administration-needs-focus-first-vaccine-doses-n1256293
(4) “Covid trial in UK examines mixing different vaccines,” BBC News, Feb. 4, 2021. https://www.bbc.com/news/health-55924433?ftag=MSF0951a18
Preprint Research Articles and Press Releases:
(1) “Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose. A reanalysis of a study of ‘real-world’ vaccination outcomes from Israel,” MedRxiv, Feb. 1, 2021. https://www.medrxiv.org/content/10.1101/2021.02.01.21250957v1
(2) “Single Dose Administration, And The Influence Of The Timing Of The Booster Dose On Immunogenicity and Efficacy Of ChAdOx1 nCoV-19 (AZD1222) Vaccine,” Lancet, Feb. 1, 2021. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3777268
(3) “Single Dose Vaccination in Healthcare Workers Previously Infected with SARS-CoV-2,” MedRxiv, Jan. 30, 2021, https://www.medrxiv.org/content/10.1101/2021.01.30.21250843v3
“Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial,” Johnson & Johnson, Jan. 29, 2021. https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial
“COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials,” AstraZeneca, Feb. 3, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/covid-19-vaccine-astrazeneca-confirms-protection-against-severe-disease-hospitalisation-and-death-in-the-primary-analysis-of-phase-iii-trials.html
Why am I doing this?
The coronavirus pandemic will be indelibly written on our memories just as the Great Depression or the Battle of Britain left their mark on past generations. I intend to journal the pandemic experience from three perspectives: as a retired medical technologist, as a historian (Ph.D., 2014), and an ordinary person living through an estraordinary world crisis.
You are on History’s Edge.