New government guidance on the COVID vaccination program has come under severe criticism today. The initial vaccination program, which required 2 doses of either the Pfizer BioNTech or the Oxford AstraZeneca vaccine to be administered within a 3 week time frame, has been changed and GP’s are now being advised to prioritise getting the first dose distributed to as many people as possible. As it stands, this means that the second dose could be delayed for a number of weeks or even months. The government have also advised GPs that they can now mix different vaccines, where options are limited. In other words, your first dose could be the Pfizer vaccine but the second dose could be the AstraZeneca vaccine (or anything else they might approve and have available in the mean time).
Needless to say, this draws into question the efficacy of the UK COVID vaccination program because while these drugs have had extensive testing, they were tested specifically in accordance with the 3 week dosing time frame and no tests have been conducted as to the efficacy of combining different vaccines. Spotlight contacted Pfizer UK for a comment and received a detailed statement in response…
Pfizer, BioNTech and the JCVI [Joint Committee on Vaccination and Immunisation] are guided by a shared sense of urgency to try to solve for this devastating pandemic.
Recommendations on alternative dosing regimens reside with health authorities and may include recommendations beyond the label due to public health principles. As a biopharmaceutical company working in a highly regulated industry, our position is supported by the label and indication agreed upon with regulators, and informed by data from our Phase 3 study.
Pfizer and BioNTech’s Phase 3 study for the COVID-19 vaccine was designed to evaluate the vaccine’s safety and efficacy following a 2-dose schedule, separated by 21 days. The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.
Data from the Phase 3 study demonstrated that, although partial protection from the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide the maximum protection against the disease, a vaccine efficacy of 95%. There are no data to demonstrate that protection after the first dose is sustained after 21 days.
While decisions on alternative dosing regimens reside with health authorities, Pfizer believes it is critical health authorities conduct surveillance efforts on any alternative schedules implemented and to ensure each recipient is afforded the maximum possible protection, which means immunization with two doses of the vaccine.
We remain committed to our ongoing dialogue with regulators, health authorities and governments, including the U.K., and to our continued data sharing efforts to help inform any public health decisions aimed at defeating this devastating pandemic.
Spotlight has also contacted AstraZeneca for comment and we will update you as soon as we’ve had a reply.
What seems to be clear from the Pfizer statement is that they do not recommend and cannot vouch for the efficacy of the UK vaccination program if doses are delayed for more than 21 days and/or patients are given a completely different vaccine for their second dose.
Equally concerning might be the possible side effects or consequences of delaying or mixing vaccines, given that neither of these scenarios were investigated during the earlier trials and it’s worth noting that, in their statement, Pfizer have been clear to say… “our position is supported by the label and indication agreed upon with regulators”. Which points to the fact that the government’s newly proposed vaccination program has ‘not’ been agreed by the regulators.
The head of immunisations for Public Health England (PHE), Dr Mary Ramsay, has also spoken out against mixing COVID-19 vaccines from different suppliers, indicating that the potential risks or consequences are either too great or simply unknown.
According to the Metro, both Pfizer and AstraZeneca have challenged the governments grounds for switching to a program that would prioritise first doses for as many people as possible – specifically an expected shortage in vaccine supplies – stating that ‘millions of doses’ have already been delivered to the NHS and that there are no supply issues from their perspective. The Metro also reports that NHS bosses do not see any issues with supply either.
There is speculation of course that this change of guidance, coming just 2 days after Britain left the EU, might indicate that the government is expecting significant disruptions in supply post Brexit. Certainly there were some concerns raised about vaccine supplies early in December with government ministers speculating that alternative transportation arrangements might have to be considered – statements that now seem to conflict with Boris Johnson’s claim that the issue is one of supply and not distribution. Of course concerns over distribution would have been significantly worse under a no-deal Brexit but even under the current arrangements, most distributors are still expecting some impact on distribution channels and many have taken the decision to delay shipments rather than have their drivers and lorries locked in tail backs or sitting in lorry parks. The government are also fully expecting there to be serious disruptions to transportation, demonstrated clearly by the fact that many Dover residents received a govt letter on New Year’s Eve telling them that large sections of farmland and ancient Roman ways are to be given over to a customs clearance lorry park for 1,200 trucks.
The UK’s steep rise in COVID cases will no doubt be adding further pressure on the government to act. The government’s own figures, updated only this afternoon, paint a grim picture, with the situation only expected to get worse – given that the government decided not to go into full lockdown over Christmas and the fact that we are now into January, statistically the most stressful month in the NHS calendar…
Worth remembering too that furlough and business support grants were expected to end soon but with case rates worse now than at the first peak and continuing to rise, unless something can be done to dramatically reduce the infection rate, we might be looking at another lockdown and another extension to the furlough scheme – something the government will likely want to avoid if at all possible. The question is, are they that determined to avoid extending the furlough scheme that they’re be prepared to change UK’s vaccination program and potentially risk the health of millions of people?