Covid-19: Government poised to amend regulations to allow use of unlicensed vaccine
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3757 (Published 28 September 2020) Cite this as: BMJ 2020;370:m3757Read our latest coverage of the coronavirus outbreak
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Dear Editor
I think Peter Todd [1,2] might agree with me that the government’s defensive behaviour over Pandemrix eleven years after the Swine Flu “pandemic” does not create confidence. On any precedent those that are harmed or their families will have to fight tooth and nail for years to get the slightest recognition [3]. Moreover, the Prime Minister’s repeated dismissive rhetoric about “anti-vaxxers” is scarcely likely to convince or earn trust [4]. The fear is that the government have invested so much of our money and their reputation that it will press on ignoring all contrary signals.
[1] Clare Dyer, ‘Covid-19: Government poised to amend regulations to allow use of unlicensed vaccine’, BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3757 (Published 28 September 2020)
[2] https://www.hja.net/legal-team/peter-todd/
[3] John Stone, ‘Re: A tale of two vaccines’, 17 August 2020, https://www.bmj.com/content/363/bmj.k4152/rr-29
[4] John Stone, ‘ Regarding the Use of the Term "Anti-Vaxxer"’, 27 August 2020, https://www.bmj.com/content/370/bmj.m3099/rr-5
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor
Dear Editor
“Unlicensed Vaccine”. The term implies that EITHER the manufacturer has not bothered to apply for a licence OR is scared that the licence will be refused.
It is unimaginable that a manufacturer will not want to recoup the costs of developing the product.
The readers will be aware that the Astra Zeneca vaccine trials had halted in every country.
Now they have restarted everywhere, EXCEPT the USA.
Why are the Americans still hesitant?
Competing interests: No competing interests
Government proposing to roll out “Triumph” and “Ambush” vaccines next month?
Dear Editor
Following Clare Dyer’s disturbing report [1] it does indeed look as if the government may be intending roll out two unlicensed Covid vaccine products as early as next month. In a BBC report last week which seemed so fanciful I was inclined to ignore it products were injudiciously codenamed by government agencies as “Triumph” and “Ambush”. The report by Michele Paduano, however, is still there and states [2]:
“Mass vaccination sites and mobile facilities are being commissioned as part of as a "fairly massive exercise"...According to the document, the two vaccines are called Ambush and Triumph...Ambush needs to be stored at -70C (-94F) and kept in hospitals due to regulations set down by the Medicines Health Regulatory Authority.“
The “Triumph“ vaccine is believed to be the Oxford Astra Zeneca product which has to be administered twice within 28 days. The refrigeration requirements for the “Ambush” vaccine fit the the profile of both the Moderna and Pfizer products [3]. A similar but less detailed report has now appeared in the Sun newspaper [4].
All three vaccines have been criticised for their effectiveness by Peter Doshi and Eric Topol in the New York Times [5] and by William Haseltine in the Washington Post [6]. Both the Oxford and Moderna vaccines are known to have unpleasant side-effects [7]. The Oxford vaccine when I last heard was still under investigation by the FDA [8].
Against which background one can only echo once again the editor’s call a few weeks ago for “Less haste, more safety”.
[1] Clare Dyer, ‘Covid-19: Government poised to amend regulations to allow use of unlicensed vaccine’, BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3757 (Published 28 September 2020)
[2] Michele Paduano, ‘ Coronavirus: Doctors told to plan for vaccination scheme’, BBC News 2 October 2020, https://www.bbc.co.uk/news/uk-england-birmingham-54375643
[3] Jaimy Lee, ‘ Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures, raising questions about storage, distribution’, MSN 31 August 2020, https://www.msn.com/en-us/health/medical/moderna-and-pfizer-e2-80-99s-co...
[4] Nick McDermott, ‘ VACCINE BOOST Covid vaccine to be rolled out by NHS from next month with tens of thousands of people to get jabs daily by Christmas’, The Sun 8 October 2020, https://www.thesun.co.uk/news/12872851/covid-vaccine-nhs-jab-christmas/
[4] Jaimy Lee, ‘ Moderna and Pfizer’s COVID-19 vaccine candidates require ultra-low temperatures, raising questions about storage, distribution’, MSN 31 August 2020, https://www.msn.com/en-us/health/medical/moderna-and-pfizer-e2-80-99s-co...
[5] Peter Doshi &Eric Topol, ‘ These Coronavirus Trials Don’t Answer the One Question We Need to Know’, New York Times 22 September 2020, https://www.nytimes.com/2020/09/22/opinion/covid-vaccine-coronavirus.html
[6] WillIam Haseltine, ‘Beware of covid-19 vaccine trials designed to succeed from the start’, Washington Post 22 September 2020, https://www.washingtonpost.com/opinions/2020/09/22/beware-covid-19-vacci...
[7] Hilda Bastian, ‘ Covid-19 Vaccines With ‘Minor Side Effects’ Could Still Be Pretty Bad’, Wired 21 July 2020, https://www.wired.com/story/covid-19-vaccines-with-minor-side-effects-co...
[8] Daniella Genovese, ‘ FDA widens probe into AstraZeneca's US coronavirus vaccine trial: report’, FOXBuisness 1October 2020, https://www.foxbusiness.com/markets/fda-widens-safety-inquiry-astrazenec...
[9] Fiona Godlee, ‘ Covid-19: Less haste, more safety’,
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3258 (Published 20 August 2020)
Competing interests: AgeofAutism.com, an on-line daily journal, concerns itself with the potential environmental sources for the proliferation of autism, neurological impairment, immune dysfunction and chronic disease. I receive no payment as UK Editor