Tuesday, November 17, 2020

Could a no-deal Brexit affect COVID-19 vaccine imports?

With just 45 days until Britain leaves the EU, there are fears that a deal may not be struck and that this could seriously impact the UK's ability to secure, ship in and distribute a COVID-19 vaccine.

Such a scenario might be considered scaremongering, but there are many warnings from ports, customs and experts that suggest a no-deal Brexit could affect the import and export of all goods to and from the UK as companies and the ports themselves are ill prepared [Guardian].

Hope of a vaccine

Last week markets were lifted by the hope of a COVID-19 vaccine on the horizon. On the 9th November Pfizer BioNTech vaccine released data which showed it had developed a vaccine with some 90% efficacy [Pfizer / BBC]. Global stocks soared and headlines speculated that life could soon return to normal. But the euphoria soon subsided after details emerged that the new Pfizer BioNTech vaccine had to be stored in very specific conditions, specifically that it had to be stored at -80°C.

However, within hours of the announcement of the breakthrough the UK Health Secretary Matt Hancock said the NHS and GPs should prepare from December to roll out the new coronavirus vaccine if it gets approved [BBC].

This week Moderna, another US drug company, announced it had also developed a vaccine with 94.5% efficacy. The Moderna vaccine also had the advantage that it could be stored in a normal refrigerator and could even remain stable for short periods of time at room temperature [Guardian].

On the face of it breakthroughs in the development of a COVID-19 vaccine are indeed positive news. Indeed, Dr Tal Zaks, Moderna's Chief Medical Officer, described the latest breakthrough as "the greatest moment of my life."

But there are a great many hurdles ahead. Despite the positive headlines, the news has to be tempered by stark realities.

The first major hurdle is production. Pfizer has said it should be able to produce up to 1 billion doses by the end of 2021. "Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021," the company said. Meanwhile Moderna said in September that it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, though given the positive news this week it is likely to up production.

Even so, even at full capacity, neither company is likely to provide the numbers of doses needed to help restore a sense of normalcy.

The US population exceeds 330 million people and with current estimates only Pfizer could potentially roll out enough doses for the entire population before it could offer the product to other countries. To further emphasise the issue the US government has stated that it has purchased at least the first 100,000 doses [HHS].

Of course there are other vaccines being researched, at least 50 though only 10 have entered phase 3 trials. But even if the companies researching these vaccines make breakthroughs in the coming weeks or months they will face an uphill struggle to catch-up Moderna and Pfizer BioNTech in terms of rolling out production of doses [RAPS-COVID-19 vaccine tracker].

Securing a vaccine 

Moreover, the big hurdle for some countries will be securing and purchasing the vaccine.

The EU has already made deals with Moderna having been in talks with the company for its experimental COVID-19 vaccine at least since July, an internal EU document seen by Reuters showed.

On 24th Aug the EU Commission, which conducts talks with vaccine makers on behalf of EU states, said exploratory talks with Moderna had been concluded with the aim of signing a contract for the supply of 80 million doses of its vaccine, with the option of buying another 80 million [Reuters]. And on 16th November it emerged that the EU had also established plans to authorise a deal with German biotech firm CureVac, which is still in phase 2 trials, to secure up to 405 million doses of its potential COVID-19 vaccine [Reuters]. Both deals would easily enable, if properly distributed, allow the EU to vaccinate the entire block.

Earlier this year the UK government rejected the chance to join the EU's COVID-19 vaccine scheme [Euronews]. Thus Great Britain will have to make its own plans. In this regard the UK has agreed to purchase vaccines from several companies including 90 million doses from Janssen [BBC / UK Govt], and has reportedly ordered 30 million doses of  the Pfizer vaccine and hopes to receive 10 million doses by the end of the year [Mirror].

The UK has also reportedly signed a deal to purchase some 190 million doses of another, as yet unapproved, vaccine VLA2001 from the French pharmaceutical company Valneva [Pharmaphorum / Valneva]. 

Aside from the potential challenges faced by the UK concerning securing the right vaccines and its distribution, there have been questions as to whether Britain's leaving the EU could affect the import of the vaccine.

Brexit "won't delay supplies", govt claims

Grant Shapps, the UK Transport Secretary has insisted that Brexit will not cause disruption to the import of a vital coronavirus vaccine into the UK should talks with the EU conclude in a no deal scenario, and the Health Secretary Matt Hancock has also said he is "confident" a no-deal Brexit won't delay supplies, amid concern the Pfizer vaccine could be affected by Britain's EU departure.

However, only a week before the announcement concerning the Moderna vaccine, the National Audit Office warned that the government had not done enough to get the UK's borders ready for leaving the single market and customs union and that there would be disruption whether or not a trade deal was signed [Independent]. 

No-deal risks

Last year as a potential no-deal Brexit loomed in October some experts warned that some disruption was inevitable. "Despite intensive preparation by industry for every scenario, a no-deal Brexit risks disruption to the supply of medicines" throughout the EU, Andy Powrie-Smith, an official at the European Federation of Pharmaceutical Industries and Associations, told Reuters.

The warnings were echoed by the Guild of Healthcare Pharmacists who said that leaving the EU without a deal would bring a "significant risk" of disruption to the supply of medicines and medical devices [Pharmaceutical journal].

With less than 45 days to secure and ratify a deal with the EU many fear that a no-deal Brexit is more likely than ever.

And with ports warning that such a scenario will cause unprecedented chaos, even if vaccines are fast tracked the physical problems shipments might encounter on the road could hold up supplies [Sky News].

Whilst it may be the case that a vaccine may not be available well into 2021 due to the approval process required, the issues surrounding the importing of medicines and particularly much needed COVID-19 vaccines might well be impacted negatively by a no-deal Brexit.

tvnewswatch, London, UK

No comments: