By Sonia Joshi
The devastating impact COVID 19 has, at the time of writing this article, resulted in over four million confirmed cases of coronavirus and more than 116,000 COVID 19 related deaths in the UK according to government figures.
The development, approval and deployment of a range vaccines against SARS CoV 2 has been a game changer in our fight against COVID 19 by reducing people’s chances of getting sick, needing hospitalisation and dying from the disease. In combination with public health measures, a global vaccination program will play a pivotal role in an ‘exit’ strategy from the pandemic.
Dentists see a wide variety of patient populations, some of whom may visit the dentist but don’t visit a primary care physician or other medical professional on a regular basis. As trusted health professionals, we can play a key role in helping to communicate the importance of vaccinations in supporting our patients and staff members about the COVID19 vaccines currently on offer.
We have collated some key FAQs your patients and team members may have for you along with a list on resources and articles you can direct them to for further information. At the time of writing, the Moderna vaccine in not currently available, the information below relates mainly to the Astra Zeneca/Oxford and Pfizer COVID 19 vaccines.
SECTION A: DIFFERENT VACCINES
IS A VACCINE NECESSARY?
COVID 19 can be a minor hindrance or lead to severe disease or even death. While hygiene measures such as social distancing, handwashing, and wearing masks offer some help, the best way to stop this virus is to generate specific immunity against the virus.
No virus has ever eliminated itself by inducing natural immunity in a large percentage of the population. Only herd immunity induced by vaccination can eliminate viruses, as has now been shown for smallpox and two of the three different types of poliovirus.
The COVID 19 vaccine should help reduce the rates of serious illness and save lives and will therefore reduce pressure on the NHS and social care services.
WHICH VACCINES ARE CURRENTLY AVIABLABLE IN THE UK?
Both the Pfizer/BioNTech and Oxford/AstraZeneca COVID 19 vaccines are now available. Moderna COVID 19 vaccine has also been approved but is not yet available.
All approved vaccines have been shown to be safe and offer high levels of protection.
HOW DO THE VACCINES DIFFER?
Astra Zeneca/ Oxford
How it works: The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common virus which causes colds in chimpanzees. Researchers have already used this technology to produce vaccines against a number of pathogens including Flu.
The virus is genetically modified so it is impossible for it to grow in humans. Scientists have transferred the genetic instructions for coronavirus's specific 'spike protein' to the vaccine. When the vaccine enters cells inside the body, it uses this genetic code to produce the surface spike protein of the coronavirus. This induces an immune response, priming the immune system to attack SARS CoV 2 if it infects the body.
Pfizer
How it works: Pfizer and Moderna have both developed RNA vaccines. They inject a tiny fragment of the virus's genetic code into the body, which starts producing part of the coronavirus and pushes the body to mount an immune response. No virus is needed to create an mRNA vaccine. This means the rate at which the vaccine can be produced is accelerated.
Although this is the first mRNA vaccine, researchers have been working on the development of mRNA vaccines for 10 years. This pre-existing technology allowed the rapid synthesis of a clinical-grade vaccine. In fact, within a week after the SARS-CoV-2 sequence was made public, mRNA vaccines were being produced in the laboratory.
ARE THEY ALL EQUALLY EFFECTIVE?
It is hard to compare one company's results with another as their trials will have been conducted in slightly different ways and at different points in the pandemic. A summary of the main findings from the Astra Zenca/ Oxford vaccine and Pfizer vaccine trials are given below.
It is important to remember that both seem to have a large impact on reducing the chances of severe disease or death from COVID 19.
Effectiveness:
Data published in The Lancet, has looked at the overall effectiveness of the Astra Zeneca/ Oxford vaccine. The overall Lancet data, which was peer-reviewed, set out full results from clinical trials of over 20,000 people. The Oxford vaccine has a short-term efficacy of 73 per cent after one dose, and longer-term protection of around 70 per cent after two doses. In addition, no severe cases or hospitalisations were recorded in the patients given the vaccine during the trial.
Effectiveness:
Data published in the New England Journal of Medicine, looked at the overall effectiveness of the Pfizer vaccine. The overall NEJM data, which was peer reviewed, set out results from clinical trials of more than 43,000 people. A two-dose regimen of conferred 95% protection against Covid-19 in persons 16 years of age or older. In addition, no severe cases or hospitalisations were recorded in the patients given the vaccine during the trial.
ARE THE VACCINES EFFECTIVE AGAINST NEW VARIANTS?
New versions of the coronavirus are emerging in countries around the world and we are still waiting for large scale ‘real time data’. Early analysis shows current vaccines have a reduction in efficacy against some of the variant viruses, particularly 501.V2 or B.1.351 strain from South Africa, but it is thought that vaccines should still protect against severe disease, hospitalisations and deaths.
Fortunately, modifications to current vaccines to combat the emerging variants are in development with roll out of a ‘tweaked’ Oxford vaccine being suggested for Autumn.
SECTION B: SAFETY
ARE THE VACCINES SAFE?
Some people have voiced concerns about how quickly the COVID 19 vaccines have been developed and whether this impacts their safety.
Simply said, yes, the vaccines are safe and highly effective and have been approved by the MHRA; the official UK regulator authorising licensed use of medicines and vaccines by healthcare professionals.
The current vaccines on offer have been able to be rolled out quickly for various reasons:
Platform technology
- Scientists have been preparing for ways to tackle unknown emerging pathogens for some time including fast and flexible ways for developing new vaccines against the emergence of unknown viruses. The resulting development of ‘platform technologies’ allows a ‘plug and play system’ that involved inserting genetic material from the virus into a tried and tested delivery package.
- This pre-existing technology allowed the rapid synthesis of a clinical-grade vaccine, with a known safety profile and faster and cheaper production process.
- Some of these platform technologies, such as the mRNA vaccine platform technology used by Pfizer and that used by Oxford/ Astra Zeneca, have been in development for over a decade.
- The rapid sequencing and publishing of the SARS-CoV-2 genome: work that was also underway on other coronaviruses and the platform technologies meant development of a vaccine was accelerated as soon as the genetic sequence was available.
Clinical Trials
1. Different phases of the clinical trial were delivered to overlap instead of running sequentially which sped up the clinical process.
After many years of running vaccine studies, clinical trials have been developed to become more streamlined. Studies were designed so that Phase 1 (first in human; initial safety) and Phase 2 (safety, and dose finding studies) could be rolled into one study. If Phase 1 shows adequate safety, Phase 2 can start immediately — without designing another study and waiting for more regulatory hurdles. Phase 3 studies (studies to see if the vaccine is effective) were designed while the phase 1 and 2 trials were being conducted, based on assumption that the vaccines would be safe and effective in the Phase 1 and 2 studies.
2. Rolling approval of the data.
It can typically take 6-9 months for new medicines to be approved but this is largely because data is often delivered to regulatory agencies in one go at the end of a trial. In the case of COVID 19vaccines, the process has been accelerated by a rolling review which meant assessment of data packages were available for review as the
trials were being delivered so experts at the MHRA could as questions in real time and speed up delays caused by administrative processes.
3. Unprecedented recruitment of candidates from the community
The vaccine benefited from huge support from the community in the form of participants who were willing to rapidly enrol into studies that vaccinated around 43,000 volunteers for the Pfizer study and over 20, 000 for the Astra Zeneca/ Oxford study. Such rapid enrolment is somewhat unprecedented.
Finally, the skyrocketing rates of COVID-19 in the United States and other countries where these vaccines were tested meant there were enough infections to occur during the time of the trials to give us a rapid answer as to whether the vaccine was effective.
4. Funding
A key consideration for any medicine/ vaccine development is funding. The research and development is often expensive however high urgency and demand opened up public and private funding, pushing aside the usual financial barriers to expedite vaccine development.
We now have safety data on more than 40,000 participants (Pfizer) and over 20 000 (Astra Zeneca), and they were both found to be safe and tolerated within those numbers. Obviously, very rare side effects that occur in fewer than one in 10,000 vaccine recipients likely will be missed. However, safety will continue to be evaluated even after approval.
WHAT IS THE EVIDENCE TO SHOW THE VACCINES ARE SAFE FOR BAME COMMUNITIES?
The Public Assessment Reports contain all the scientific information about the trials and information on trial participants.
For the Pfizer vaccine, participants included 9.6 percent black/African, 26.1 percent Hispanic/Latino and 3.4 percent Asian.
For the Oxford/AstraZeneca vaccine, 10.1 percent of trial recipients were Black and 3.5 percent Asian.
There is no evidence either of the vaccines will work differently in different ethnic groups.
RISK OF ANAYPHYLAXIS WITH THE PFIZER VACCINE vs. THE ASTRA ZENECA/OXFORD VACCINE.
The vaccine should not be given to those who have had a previous systemic allergic reaction (including immediate-onset anaphylaxis) to:
· a previous dose of the same COVID-19 vaccine
· any component (excipient) of the COVID-19 vaccine.
The Pfizer COVID-19 Vaccine contains polyethylene glycol (PEG), which is from a group of known allergens commonly found in medicines and also in household goods and cosmetics. Known allergy to PEG is extremely rare, but would contraindicate receipt of this vaccine.
Patients with undiagnosed PEG allergy may have a history of unexplained anaphylaxis or of anaphylaxis to multiple classes of drugs.
The AstraZeneca vaccine does not contain PEG, and is a suitable alternative.
CAN THESE GENETIC VACCINES ALTER MY DNA OR HAVE LONG TERM SIDE EFFECTS?
There has been inaccurate information circulating online about the new technologies used for the Pfizer-BioNTech and Oxford-AstraZeneca vaccines. Whilst these technologies both use genetic codes to produce the spike protein inside the body, this code cannot be incorporated into the body’s DNA. This is because:
· mRNA vaccines like the Pfizer/BioNTech vaccine cannot reach the part of the cell that holds the DNA, called the nucleus.
· mRNA cannot be translated back into DNA.
· Both mRNA and adenovirus vaccines do not contain the “specialised tools” needed to “copy” or “edit” DNA.
These vaccines cannot replicate inside the body and only stay in the body for a few days. After helping the cells to produce an immune response against the spike protein, the vaccine is removed by the body. In addition, most negative effects occur within 6 weeks of receiving a vaccine, which is why the FDA and MHRA have asked the companies to provide 8 weeks of safety data after the last dose.
WHAT IS IN THE VACCINE? IS THE VACCINE VEGAN/VEGETARIAN FRIENDLY?
There is no material of foetal or animal origin in either vaccine. All ingredients are published in healthcare information on the MHRA's website.
For the Pfizer/BioNTech vaccine information is available here.
For the Oxford/AstraZeneca vaccine information is available here.
CAN THE VACCINE CAUSE INFERTILITY?
Infertility has not been found to be an issue in women infected with COVID-19, so it would not be expected to be a concern for the vaccine. Concerns about antibodies generated by the COVID-19 vaccine attacking syncytin-1, a protein associated with the placenta during pregnancy, are unfounded. The claims, which circulated online, were based on a small number of similar amino acids in the two proteins, but the overlap is not sufficient to cause such a reaction. This notion has been addressed by Full Fact.
Advice for pregnant women
Although the available data do not indicate any harm to pregnancy, there is insufficient evidence to recommend routine use of COVID 19 vaccines during pregnancy.
The Joint Committee on Vaccination and immunisation (JCVI ) has advised that vaccination in pregnancy should be considered if the risk of exposure to SARS-CoV2 infection is high and cannot be avoided, or where the woman has underlying conditions that put them at very high risk of serious complications of COVID 19.
In these circumstances, clinicians should discuss the risks and benefits of vaccination with women who are pregnant and discuss the pros and cons.
ARE THERE ANY CONTRAINDICATIONS TO RECEIVING THE VACCINE IF YOU ARE ON MEDICATION ALREADY PRESCRIBED FOR HIGH BLOOD PRESSURE AND THYROID PROBLEMS?
There are no contraindications to receiving the vaccine if you are on medication prescribed for high blood pressure and thyroid problems.
IS THE VACCINE SAFE FOR PEOPLE WITH AUTOIMMUNE DISEASE? IS THERE ANY REPRESENTATION OF THIS GROUP OF PATIENTS IN THE TRIALS?
The vaccine is inactivated and there is no contraindication to its use in immunocompromised individuals or those with autoimmune disease.
Those in clinically vulnerable patient groups are high priority for the vaccine.
CAN YOU HAVE THE VACCINE IF YOU TAKE WARFARIN?
Yes, with the most recent result of the INR, which should be within the range for you.
SECTION C: PRACTICAL QUESTIONS
IF I’VE HAD COVID 19 – DO I STILL NEED THE VACCINE?
COVID-19 vaccination should be offered to you regardless of whether you already had COVID-19 infection. You should not be required to have an antibody test before you are vaccinated. However, anyone currently infected with COVID-19 should wait to get vaccinated until after their illness has resolved and after they have met the criteria to discontinue isolation. We currently recommend waiting 28days from the onset of your infection.
IS THERE ANYONE WHO SHOULD NOT GET THE COVID-19 VACCINE?
- Anyone with a previous severe or immediate allergic reaction (i.e., one that causes anaphylaxis or requires medical intervention) to a COVID-19 mRNA vaccine dose, a vaccine component, or polysorbate. Please speak to your healthcare provider if you have any concerns.
- Those younger than 16 years of age.
- People currently isolating or experiencing symptoms of COVID-19; these people can get vaccinated once they have finished isolation and their primary symptoms have resolved.
CAN I HAVE THE COVID 19 VACCINE AT THE SAME TIME AS OTHER VACCINES?
People should separate their COVID-19 vaccinations by at least 14 -28 days from any other vaccine (before or after). This recommendation is based on the fact that there is no current data regarding whether the COVID-19 vaccines will affect, or be affected by, other vaccines. Speak to your healthcare professional for further advice.
CAN I CHOOSE WHICH VACCINE I GET?
Current vaccine programmes are only able to offer the vaccines in line with the supply available to them. Speak to your healthcare provider if you have any concerns or have been you have been advised to take a specific vaccine.
SECTION D: Bibliography
Although by no means exhaustive, you might find the following sources provide more helpful information:
https://www.ucl.ac.uk/news/headlines/2020/dec/debunking-covid-19-vaccine-myths This links to Huffington post articles https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-q-and-a-covid-19-vaccine-myths/
COVID-19_vaccination_programme_guidance_for_healthcare_workers_11_February_2021_v3.3.pdf
Polack, F.P., Thomas, S.J., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Perez, J.L., Pérez Marc, G., Moreira, E.D., Zerbini, C. and Bailey, R., 2020. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. New England Journal of Medicine, 383(27), pp.2603-2615.
Ramasamy, M.N., Minassian, A.M., Ewer, K.J., Flaxman, A.L., Folegatti, P.M., Owens, D.R., Voysey, M., Aley, P.K., Angus, B., Babbage, G. and Belij-Rammerstorfer, S., 2020. Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial. The Lancet, 396(10267), pp.1979-1993.
Voysey, M., Clemens, S.A.C., Madhi, S.A., Weckx, L.Y., Folegatti, P.M., Aley, P.K., Angus, B., Baillie, V.L., Barnabas, S.L., Bhorat, Q.E. and Bibi, S., 2021. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. The Lancet, 397(10269), pp.99-111.