Covid-19: Pfizer vaccine efficacy was 52% after first dose and 95% after second dose, paper shows
BMJ 2020; 371 doi: https://doi.org/10.1136/bmj.m4826 (Published 11 December 2020) Cite this as: BMJ 2020;371:m4826Read our latest coverage of the coronavirus outbreak
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Dear Editor
A number of questions: if the 4 chief medical officers’ authorised spokesmen would be willing to share the logic behind the decisions?
1. If one has had Stevens-Johnson Syndrome, should he receive the Pfizer vaccine? OR, the Oxford-Zeneca-Alstrad one?
2. HMG has decided to extend the interval between the two doses. Is there ANY evidence that the new regimen will produce as good immunity and as long lasting immunity? When and where was the new regimen trialled?
3. HMG has also decided to use, for the second dose, a different vaccine - with different constituents and different mode of preparation. And it expects the second differently produced vaccine to act in the same way as the first vaccine, to enhance immunity. Enhance to ? 60%? 70%. 90%. . .
This is preposterous. Do the manufacturers agree with HMG? Do independent immunologists agree with HMG?
I like to have faith in any medicine I take.
Competing interests: Possibly will receive a vaccine.
Dear Editor
I am very concerned that the second dose of vaccine is to be delayed for up to 3 months when it obviously has such a low efficacy after the first dose.
Many more people can be vaccinated during this time, but at what cost to us who are most at risk?
Is it right to give some protection to many, instead of greater protection for longer to those who need it most?
I hope the government will make it clear what they have decided.
I would like to be reassured that the population will be advised of the much lower efficacy after first dose, and urged to still self distance or shield until they have received the second dose.
Many people will be totally unaware of the much lower efficacy of this action.
I hope this is not a decision based on what suits rather than what is correct.
E. Leggett.
Competing interests: No competing interests
Dear Editor
Since the UK launch of the Pfizer Biotech vaccination programme, two NHS workers have experienced adverse reactions of anaphylaxis after their first jabs. These are presently being investigated by the UK regulator MHRA.
Now the very same thing has occurred in the US as they have now commenced vaccination using the Pfizer-Biotech vaccine, two health workers have also had adverse reactions, one anaphylaxis requiring hospitalisation the other felt faint and dizzy after receiving the first jab.
In the case of the UK adverse reactions, a vaccine component Polyethylene Glycol (PEG) was considered to be the primary cause. Apparently PEG has been well cited in the medical literature as a pharmaceutical component which causes severe allergies. Should the MHRA have an urgent review of the temporary approval for the Pfizer-BioNtech vaccine before more adverse cases arise with possible fatalities?
References:
Wylon, K., Dölle, S. & Worm, M. Polyethylene glycol as a cause of anaphylaxis. Allergy Asthma Clin Immunol 12, 67 (2016). https://doi.org/10.1186/s13223-016-0172-7
Priya Sellaturay, Shuaib Nasser, Pamela Ewan, Polyethylene Glycol–Induced Systemic Allergic Reactions (Anaphylaxis The Journal of Allergy and Clinical Immunology: In Practice, 2020,
Competing interests: No competing interests
Dear Editor
This afternoon a Minister announced that there is a new variant of Covid-19 in England.
May I ask the Chief Medical Officer, or his duly authorised deputy, whether he has unimpeachable evidence that the currently available vaccine here in the UK will produce adequate immunity against the new variant?
I would want a MEDICAL statement. Not a MINISTERIAL utterance.
Competing interests: No competing interests
Dear Editor
Might Mr Gussett, retired Q C ( rapid response;) please forgive me for slight disagreement?
1. He suggests that the EMPLOYERS of the two cases of severe allergic reaction were possibly at fault.
2. I suggest that the persons who carried out the injections should have explored the history. If they did not, then they were guilty of negligence. If they did, discovered the history of allergy AND that the persons being injected carried adrenaline pens, they should have consulted a registered medical practitioner.
Did the registered medical practitioner concerned still give the go ahead for the injection? If so, did he ask for the injected person to be kept for half an hour, before being sent on his way?
If he did not, then he ought to be educated.
3. As a patient, a possible subject to vaccination, I ask the Chief Medical Officer:
What instructions have you given for the conduct of these vaccinations ( more correctly, immunisation procedures.)
4. Clearly this is a matter for the Health and Safety at Work etc to investigate thoroughly. Never mind that the MHRA is looking in to it. It is a matter of law enforcement.
5. One may or may not have full confidence in the steps undertaken by the regulator before allowing the vaccine to be used.
6. But it should be clear to anyone with a modicum of commonsense that they are injecting, not normal saline, but a DRUG.
7. Finally, the long term adverse reactions. Who is organising the identification,collection, recording, analysis of adverse reactions? AND PUBLICATION THEREOF?
Competing interests: I have allergies and also a history of Stevens Johnson Syndrome ( retrospective diagnosis).
Dear Editor
Herbert P Gussett (12 December 2020) asks, “Did their employer, an NHS Trust not first check their medical records and histories in detail for indications of severe allergic reactions to medication and other substances? If not, this could be case of negligence. Had either case resulted in a fatality, it certainly would.”
Even when offering the annual flu vaccine to NHS staff, checking one’s known allergy status is a crucial question that is routinely asked. Hence, it is extremely unlikely the same was not posed when offering the covid-vaccine to two staff who reportedly developed a reaction but recovered; it’s widely reported, both affected NHS staff had known allergies and were also carrying EpiPen, thus indicating they have had a very good understanding of the nature and degree of possible allergic reactions. Similarly, it is improbable that their full informed consent was not sought prior to vaccination, and further, a question of mental capacity does not arise here either..
It is not the usual practice to explore “medical records and histories in detail” in every case when carrying out mass vaccination programmes of this scale but it is essential to seek oral verification as to any known allergies; I am confident, such reasonable practice would meet the Bolam-Bolitho test. It is neither necessary, practicable, nor proportionate to check “medical records and histories in detail” in every case irrespective of one’s allergy status, and assume, Gussett is not suggesting that either.
I agree with Gussett that “it may take years to document all possible adverse reactions to the Pfizer-Biotech vaccine, some may remain latent for months or years”. In response to his question, “Is this a risk worth taking?”, I would say, given millions of people across the world are eagerly waiting for a chance to have any form of approved covid-vaccine is ample testimony to that any possible risks are worth taking; after all, generally there are no entirely risk free vaccinations or medications, and objective, fair-minded people are well aware of the same when making informed decisions.
As for serious adverse effects, it is said, “ none of the deaths was considered by the investigators to be related to the vaccine or placebo, and no covid-19 associated deaths were observed”[1]. Similarly, it is reported [1], “The safety profile of BNT162b2 was characterised by short term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups.
References
[1] BMJ 2020;371:m4826
Competing interests: No competing interests
Dear Editor
The two reported cases of health workers experiencing anaphylaxis after receiving their first vaccination of the Pfizer-Biontech vaccines, raises a number of concerns. I understand the MHRA is currently investigating them.
1. Did their employer, an NHS Trust not first check their medical records and histories in detail for indications of severe allergic reactions to medication and other substances? If not, this could be case of negligence. Had either case resulted in a fatality, it certainly would.
2. I understand other medicine regulators such as the FDA in the US have asked the MHRA for full details of these adverse reaction cases.
3. The Pfizer-Biontech vaccine is novel and has no previous regulatory history, thus the MHRA has no substantial bank of data on possible adverse reactions. In a sense it is learning on the job. This does not bode well. The MHRA have only given temporary approval under EC regulation 174 since the Huam Medicine Regulations 2012 were amended by the UK government to permit this. Presumably approval can be revoked if further cases of anaphylaxis or other adverse reactions occur.
4. It may take years to document all possible adverse reactions to the Pfizer-Biotech vaccine, some may remain latent for months or years. Is this a risk worth taking?
Competing interests: No competing interests
Re: Covid-19: Pfizer vaccine efficacy was 52% after first dose and 95% after second dose, paper shows
Dear Editor
Can you explain how efficacy works?
i.e. Is each person in the one dose category 52% immune or are 52% of the population 100% resistant and 48% unprotected.
Competing interests: No competing interests