UK Delays Second Pfizer / BioNTech Admission: This is What We Know

The medical staff will receive the Pfizer-Biontech Covid-19 coronavirus vaccine in the Favoriten Clinic in Vienna on December 27, 2020 on the occasion of the launch of the Pfizer-BioNTech Covid-19 coronavirus vaccine.

Georg Hochmuth | AFP | Getty Images

The UK’s decision to delay the administration of the second dose of a coronavirus vaccine is controversial as experts, advisors and vaccine manufacturers weigh the strategy.

The UK was one of the first countries in the world to launch a mass vaccination campaign against the coronavirus after approving the Covid-19 vaccine developed by Pfizer and BioNTech in early December. Oxford University and AstraZeneca began rolling out the vaccine on Monday of this week after it was approved for use just before the New Year.

As both vaccines require two doses per person, the UK government initially said that a second dose would be given either three or four weeks after the first dose, depending on which vaccine was given and in line with the dosage regimens tested in clinical trials.

However, a break of up to 12 weeks is now recommended to give more people an initial dose – and initial protection against Covid-19.

Concerns from the vaccine manufacturer

BioNTech and Pfizer have responded to the decision, saying there is no evidence that their vaccine will continue to protect against Covid-19 if the second shot is given more than 21 days after the starting dose.

“Pfizer and BioNTech’s Phase 3 study of the COVID-19 vaccine was designed to evaluate the safety and efficacy of the vaccine on a 2-dose regimen separated by 21 days. The safety and efficacy The majority of study participants received the second dose within the window specified in the study design, “the companies said in a statement to CNBC on Tuesday.

“Although data from the Phase 3 study showed partial protection from the vaccine as early as 12 days after the first dose, there is no data to show that protection is maintained after 21 days after the first dose.”

The companies said it was now “critical to conduct surveillance efforts” with alternative dosing schedules in place.

The final analysis of data from the Pfizer / BioNTech clinical trials found the vaccine to be 95% effective given seven days after the second dose in preventing Covid-19.

For the Oxford University / AstraZeneca candidate, the interim analysis of the late-stage study results was somewhat more nuanced, as the vaccine doses to the study participants showed an anomaly. When the vaccine was given in two full doses, it was found to be 62.1% effective, but when some study participants received half a dose followed by a full dose of 90%. In both dosing regimens, the two shots were given one month apart. AstraZeneca was not immediately available for comment on the UK’s decision to postpone the second dose.

Reasons for the decision

The decision to extend the dosage window is made as UK hospitals struggle with increasing admissions. The coronavirus is running amok in the UK, with a new, transmissible strain of the virus spreading exponentially in London and the South East, and now appearing in other parts of the country.

To date, the country has recorded over 2.6 million cases of coronavirus and more than 75,000 deaths, according to Johns Hopkins University. The UK recorded 58,784 new cases on Monday and has now reported more than 50,000 new coronavirus cases for seven days in a row. On Monday, British Prime Minister Boris Johnson announced a third nationwide lockdown for England.

Against this dire backdrop, the UK Medicines Agency, Joint Vaccination and Immunization Committee and the UK’s four chief medical officers agreed to move the gap between the first and second vaccine dose to “protect the greatest number of people in India” the shortest Time. “

There are signs that other Britain may follow suit. The German Ministry of Health is now asking an independent vaccination commission for advice on whether the British strategy on dose delay should be adhered to. Denmark has reportedly already approved a delay of up to six weeks between the first and second vaccinations.

‘Finely balanced’

So far, more than a million people in the UK have been vaccinated with the Pfizer / BioNTech vaccine, according to government figures, and some, like the first recipient of this vaccine outside of a clinical trial, have received their second dose.

But now, thousands of others in the top priority category are being told to wait up to 12 weeks for their second dose.

The British Medical Association described the move as “grossly unfair” to thousands of high-risk patients in England, but the UK’s Independent Scientific Advisory Group on Emergencies (SAGE) said in a statement released on Sunday that it was a “very difficult and finely balanced” move be decision. “

In response to the BMA’s concerns, SAGE said, “Under normal circumstances, we would advocate continuing our previous plans to give two doses of the Pfizer BioNTech vaccine 21 days apart. However, these are not normal circumstances, and so it is are other important public health considerations. “

The UK is prioritizing vaccination of elderly care home residents, their carers, people over 80, and frontline health and social workers.

The country has pre-ordered 40 million doses of the Pfizer / BioNTech vaccine, enough for 20 million people, and signed a contract with AstraZeneca for 100 million doses, enough for 50 million people. There are around 66 million people in Great Britain.

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