The UK has approved the first vaccine against Covid. What is the criticism coming from the US and Europe? Is it just jealousy that the UK got there first?
The Medicines and Healthcare Products Regulatory Authority (MHRA) in the UK has not had a round of applause from anyone other than the UK’s politicians and the vaccine companies. It gave temporary authorisation to the Pfizer/BioNTech vaccine on Wednesday and within hours, the European Medicines Agency (EMA) put out a stiff statement implying more work was needed than the UK regulator had done. Its own decision could come as late as 29 December. It may well have been needled by the crowing of the health secretary, Matt Hancock, who claimed the fast approval as a Brexit triumph. He had to backtrack. The MHRA’s chief executive, June Raine, pointed out that the agency had simply taken advantage of a provision that any country in Europe could use, to fast-track approval in a pandemic.
Quick guide How does the Pfizer/BioNTech Covid-19 vaccine work?
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The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.
In the case of an mRNA vaccine, the virus’s mRNA is injected into the muscle, and our own cells then read it and synthesise the viral protein. The immune system reacts to these proteins – which can’t by themselves cause disease – just as if they’d been carried in on the whole virus. This generates a protective response that, studies suggest, lasts for some time.
The two first Covid-19 vaccines to announce phase 3 three trial results were mRNA-based. They were first off the blocks because, as soon as the genetic code of Sars-CoV-2 was known – it was published by the Chinese in January 2020 – companies that had been working on this technology were able to start producing the virus’s mRNA. Making conventional vaccines takes much longer.
Adam Finn, professor of paediatrics at the Bristol Children’s Vaccine Centre, University of Bristol
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Then the US dealt a blow that was even more stinging, because it came from the revered head of the National Institute of Allergies and Infectious Diseases, Prof Anthony Fauci, whose reputation has soared from standing up to Donald Trump during the pandemic. He said the US regulator, the Food and Drug Administration (FDA), was proceeding in “the correct way” and the UK “did not do it as carefully”. The FDA will meet to decide on approving the vaccine on 10 December. Later Fauci comprehensively apologised, saying he had “great faith in both the scientific community and the regulatory community in the UK”.
Does Europe do things differently?
Not usually. The EMA adopted many of the existing procedures of the Medicines Control Agency, which became the MHRA, when it was set up in the 1990s based in Canary Wharf, London. Its loss to the Netherlands post-Brexit was recognised as a blow to the UK. The EMA’s point on the vaccine was that the UK chose to go for temporary, emergency approval of specific batches of vaccine. That’s different, the EMA said, from the “conditional marketing authorisation” it hopes to grant in a few weeks, which will give the green light to any European country to use the vaccine. But apart from this spat, the agencies have generally been as one.
What about the US?
There are significant differences. The FDA is generally thought to be slower than Europe, although there is not a lot of evidence for that. They all take safety seriously – that’s the main job of a drug regulator – but the FDA seems to go an extra mile.
The FDA, the oldest and most influential regulator in the world, has a different history from the MHRA. It was set up to safeguard consumers. The Federal Food, Drug and Cosmetic Act of 1938 charged it with ensuring not only effectiveness but safety. The European rules, on the other hand, came out of the need to align commercial regulation and are sometimes seen by critics as being pro-business. The Thalidomide scandal shook up drug regulation. The US was spared the drug, which caused birth defects, thanks to an FDA pharmacologist called Frances Oldham Kelsey who blocked its licence in 1960 because she felt there was not enough safety data from the trials. In the UK and elsewhere in the world, it was that tragedy that led to a tightening of safety requirements in drug licensing.
Why is the FDA slower in appraising the vaccines than the MHRA?
The FDA says the MHRA is willing to accept what the companies say in the detailed summaries they submit about their trial results. The FDA demands all the raw data from the lab, animal and human trials as well and does its own statistical analysis. It take nothing on trust. There were more than 43,000 people in the final stage trials of the vaccine, so that is a lot of information. Stephen Hahn, the FDA commissioner, said on Tuesday that it was “one of the few regulatory agencies in the world that actually looks at the raw data.” It also convenes advisory bodies of leading experts and scientists to advise where there are scientific issues. There will be such as meeting of top minds on 10 December for the Pfizer vaccine and 17 December for Moderna – because they are both made with a brand new technology, mRNA.
The MHRA says that safety is paramount and it has cut no corners. It has an excellent global reputation to uphold and will say – or at least imply – that this is not vital.
Did the FDA make extra demands of the vaccine developers?
The FDA had specific requirements it wanted to see in a Covid vaccine licence application, including at least 50% efficacy. It was very particular about seeing the protocols for the trials – details of what they were set up to achieve and at what point the results would be analysed. Unlike the UK and European regulators, it puts all that information in the public domain. It stopped the Oxford University/Astra Zeneca trial for longer than any other regulator in the world over the death of one volunteer.
Do new drugs and vaccines take longer to get to the public in the USA?
Not necessarily, because they don’t have to go through any cost-effectiveness hurdle. In the UK, there is the National Institute for Health and Care Excellence (Nice) which will advise the NHS on whether a new drug is value for money. Prescribers in the US can and do hand out expensive new drugs as soon as they are licensed.
What other differences are there between the agencies?
They come down to the remit of each agency and the laws of the state. The MHRA’s regulation of e-cigarettes, for instance, has been fairly tightly controlled in the UK under the EU tobacco products directive, keeping the nicotine strength to no more than 20mg/ml. Not so in the US, where the FDA has been strongly criticised for failing to regulate them, but has been constrained by the courts and politicians who support business. Both agencies struggle to draw the line over herbal and complementary medicines, which are often sold as food supplements. If they are marketed as having any medicinal benefit, the MHRA can regulate. The FDA can step in if a product endangers the public, but it’s less clear cut.
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