People from minority ethnic backgrounds and deprived communities must get timely access to the new Covid vaccine, the head of a government advisory body has said, as the UK’s medicines regulator said no corners had been cut in licensing the vaccine in record time.
The public should be reassured that the Pfizer/BioNTech vaccine has been subjected to the most thorough scrutiny by experts working round the clock, said Dr June Raine, the chief executive of the Medicines and Healthcare products Regulatory Authority (MHRA).
They had recommended the Pfizer/BioNTech vaccine for a licence “following the most rigorous scientific assessment of every piece of data, so that it meets the required strict standards of safety, of efficacy and of quality”, she said at a briefing.
Europe is not expected to licence the vaccine until the end of the year. The US regulator, the Food and Drug Administration (FDA) will meet to consider it on 10 December. But, said Raine, “everyone can be absolutely confident that no corners have been cut” in the UK.
She put their speed down to hard work, dedication and a rolling review that began in June. Every piece of data has been scrutinised over the past months as it became available, without waiting for the final trial results. The safety of the public was paramount, she said.
Two more vaccines are being considered for a licence – Moderna’s, which is similar to the Pfizer jab, and Oxford University/AstraZeneca’s, which uses a different technology. Experts would be working over Christmas to assess those too, said Raine.
Prof Wei Shen Lim, the head of the joint committee on vaccination and immunisation, an independent adviser to government, said the first priority for vaccination remained people in care homes and those who looked after them, followed by the over-80s and NHS staff.
But the committee is urging local authorities and public health leaders to work together to ensure that the most needy in their communities get vaccinated “to mitigate against health inequalities that might occur in relation to ethnicity, deprivation or access to healthcare”.
“We have a vaccine that is acceptably safe and effective. Good vaccine uptake will save lives,” said Lim.
The MHRA says it is confident that the vaccine is very safe. The few side-effects reported include a sore arm and headache, which go away within a day or so, it has said. But the safety of the vaccine will be constantly monitored over the coming months and years. The MHRA has a “yellow card” system, through which the public and healthcare staff can report any adverse events. A random selection of people who have the vaccine will receive letters, asking them to feed back on their experience.
The vaccine comes in two shots, three weeks apart. But Sir Munir Pirmohamed from Liverpool University, who chairs the commission on human medicine expert working group that advised the MHRA, said there would be some effect after the first dose. “Some protection occurred after 12 days,” he said, although real immunity kicked in about seven days after the second dose.
The experts have scrutinised the quality of the manufacturing process, and batches of the vaccine will be tested to ensure they are up to standard as they arrive in the UK.
“We did look at the stability of the vaccine. It is stable at -70C. It is stable for a short period of time at 2C to 8C which allows it to be transported to the relevant vaccination sites,” said Pirmohamed.