Gerry Gajadharsingh writes:
“Between myself and my closest medical colleague Dr Barry Grimaldi FRCP, we have around 80 years of clinical experience and in excess of 15,000 patients between us.
We are both offering the new Roche Laboratory SARS- Cov2 S (spike protein) antibody test to our respective patients. It is for patients who have previously had COVID-19 symptoms (with and without positive PCR confirmation) and to patients who have had a Covid-19 vaccination. Both COVID-19 infection and vaccination target the coronavirus spike protein, hence why we think this is an incredibly useful test.
Despite this test having only been commercially available for seven weeks we have accumulated a dataset of over 150 patients and achieved in excess of 200 individual antibody results in those patients.
Antibody testing has been an accepted way of gauging immunity to either previous infection or vaccination and has been used in medicine for a number of years. For example, as I perform phlebotomy on my patients to take blood samples, it is a healthcare requirement that I have immunity to hepatitis B (a virus spread through blood and other body fluids). This is generally achieved by vaccination and measured by a blood test showing antibodies to hepatitis B, Anti-HBs. it is generally accepted that the level > 100 mIU/ml confirms immunity. In 2016 my levels were 164 mIU/ml, so I had another booster, 4 years later they were at >1,000 mIU/ml (the maximum number the lab measures). March 2021 they were still at >1,000 mIU/ml, so I expect I will not need another booster for a number of years.
With this new Roche laboratory spike protein antibody test >0.8 U/ml is considered a positive antibody response, with the maximum number at >2,500 U/ml.
So, what is our data suggesting so far?
- Patients having had previous COVID-19 (with and without PCR confirmation) at any age show a robust antibody response even up to 1 year post COVID 19 infection, averaging 264 U/ml and in the vast majority of cases, far higher than people who have had the first dose of either vaccine and who had not had COVID 19. There are over 4 million people in the UK who have had confirmed COVID-19.
Dataset 21 patients 3 weeks to 1 year post COVID 19 infection.
- The majority of patients having had previous COVID-19 tend to achieve a very high level of antibodies, averaging > 2010 U/ml after the first dose of either vaccine. This leads to the question whether those patients actually need a second dose (at least in the short to medium term), and possibly even whether it’s sensible to receive a second dose when their antibodies are so high anyway, given the reports we are reading regarding adverse reactions to some patients receiving the vaccine. Not enough information is known about those particular patients, but several European countries have now put the Oxford/AZ on hold, whilst they look at the data. Whilst this decision may well be political, we await further data.
Dataset 12 patients age range 39 to 78, 64% of patients had >2,500 U/ml
- Some countries are already taking the view that if a patient has had previous COVID-19 infection they’re only giving them one dose of vaccine. Essentially the first dose of the vaccine acts as a booster if you’ve had previous COVID-19 infection, this is now the recommendation of the French government.
- There is concern from some patients, given the suggestion regarding proposed vaccine passports and the need to have a second dose to comply with those potential requirements. It’s interesting to note that Greece has already suggested that they may accept Ab status as proof of immunity in lieu of two doses of vaccine or a negative PCR antigen test and it looks like the EU may well take a similar view, lets hope the UK government follows suit. Given that antibody tests are cheaper than PCR this may be a more cost-effective way of confirming immunity status than repeated negative PCR, assuming it is confirmed that people with COVID-19 immunity are much less likely to pass on the virus, early data suggests that this may well be the case. Given that younger age group patients are highly unlikely to get a second dose of the vaccine until much later in the year it seems incredibly unfair to penalise these very large numbers of people simply because they haven’t had a second dose and ironically on the data that we have seen if they have had COVID 19, they are achieving at least as good as an immunity response as those having a 2nd dose of vaccine.
- In the age group > 69 years of age with no history of COVID 19, we are seeing an antibody response in the majority of patients having had a first dose of either vaccine, however at low levels averaging 13 U/ml, with some patients having no antibody response at all, especially if they are taking medication that compromises their immune system.
Dataset 15 patients (4 to 7 weeks post 1st dose), there may be a suggestion that in this age group antibodies may be gradually increasing after week 7 in some patients.
- In the age group < 69 years of age with no history of COVID 19, we are seeing an antibody response in the majority of patients having had a first dose of either vaccine, averaging 92 U/ml.
Dataset 13 patients (3 to 7 weeks post 1st dose)
- In the patients <69 years of age antibody levels are decreasing from around 5 to 6 weeks post first vaccination. This is despite media reports suggesting that immunity builds up to 12 weeks post first dose of vaccine.
Dataset 4 patients
- Very few patients have had a second dose of vaccine, however the ones that have, with no history of COVID 19, all had a positive antibody response after the first dose and the week after the second dose received a significant boost to their immunity achieving an average of 1448 U/ml.
Dataset 5 patients age range 55 to 82 (1 week to 2 months post 2nd dose), with a maximum immunity response >2,500 U/ml after 1 week
- We are awaiting data on patients who have not received an antibody response after their first dose to see if they achieve an antibody response after the second dose and what level of immunity they actually achieve.
Dataset 0
- Healthcare workers are in the first 4 vulnerable categories (as stipulated by JCVI), because they are in a younger age group then most, post first dose of vaccine they are achieving much higher levels of antibody response than others, averaging 111 U/ml. This is to be expected given the general level of robustness of a younger person’s immune system compared to an older person. Recent data on healthcare workers both in the UK and Israel has backed this up, although I’m not sure why the media seem to be translating this positive response in healthcare workers to the general population, including older age groups.
Data set 7 patients (ages 23-61) 4 weeks post vaccine
Recently it’s been reported in the media that some of the UK experts are now predicting yet another wave of COVID-19 infections in autumn 2021, despite the success of the UK vaccine rollout, we’re not of the woods yet.
In an ideal world, we would have time to build data and to use science to the best of our ability to work out how well the vaccines are working or not as the case maybe.
Time has been, and still is critical, and we understand the rationale behind the UK policy and their vaccine rollout. However, if we really base policy decisions based on science perhaps the government should really consider large-scale trials using the science that we have available at the moment, spike protein antibody testing, to confirm our preliminary data. Other countries are using antibody testing, including the UAE, which is currently ranked second in terms of percentage coverage of vaccination in the world, 60% to date, as expressed in the article below, who are already looking at a third dose of vaccine for those people not achieving a significant immunity response after two doses of vaccine (mostly Sinopharm).”
Richard Spencer
The Times
Some people who have received the Chinese Sinopharm vaccine in the United Arab Emirates have had to be given a third dose to boost their response, according to local health authorities.
Doctors said that the antibody response to two doses of the vaccine — the main one offered in the UAE’s successful programme — had been variable.
Although the UAE health ministry has given few details, local newspapers reported that a “small” proportion of those who had received doses needed a third.
“Some people received a third dose of the Sinopharm Covid 19 vaccine, but the number is very minimal,” Dr Farida al-Hosani, a spokeswoman, said.
Outside the UK, the UAE is second only to Israel, from countries with a significant population, in the proportion of the population vaccinated. More than 60 per cent of its local and foreign residents have received at least one dose.
That has been in part thanks to the decision to bulk-buy the Sinopharm vaccine in advance of third-phase clinical trials, though some recipients are being given the Oxford AstraZeneca, Pfizer and Sputnik versions.
The decision has led to Dubai becoming a destination for vaccine tourism, with businessmen from around the region and even from Britain and Europe travelling there to have a vaccine privately administered.
However, doctors at some of the private hospitals distributing the vaccine say that not all patients who received Sinopharm showed sufficient levels of antibodies in subsequent tests.
“In the laboratory assessment that checked the level of antibodies production against the vaccines, some patients developed high antibodies against the virus while some showed low antibodies,” Dr Adel al-Sisi, chief medical officer at Prime Hospital in Dubai, told the Khaleej Times.
“Looking at the outcome, the third booster dose is recommended for patients having low antibodies production.”
Other doctors are recommending a third dose for people with serious health conditions.
With no peer-reviewed third-phase studies of Sinopharm, reporting on its efficacy varies. The UAE said that its own research initially showed that it was 86 per cent effective at preventing infection 28 days after a second dose, but the company itself put the figure at 79 per cent.