Elderly people and healthcare workers in the United States could receive the first doses of the vaccine against Sars-Cov-2 as early as next week.
After months of darkness, a light is beginning to appear at the end of the tunnel in the United States. On the evening of Friday 11 December, the Food and Drug Administration (FDA) – the agency that regulates the use of food and pharmaceutical products – officially gave the green light to the distribution of the vaccine against Covid-19 developed by Pfizer and Biontech, approving it for emergency use.
More than six million doses are already ready to be distributed. Around three million were shipped across the country immediately after approval, to allow care homes and hospitals to receive them as soon as possible and launch the vaccination campaign. Three weeks later, the other half of the supply will be dispatched — needed to provide a second injection to the same patients. In total, the United States has reached agreements with Pfizer-Biontech to receive 25 million doses of the new vaccine by the end of 2020, a figure that would then rise to 100 million by March 2021.
American pharmaceutical company Pfizer and its German partner Biontech began working on the vaccine in January 2020, just eleven months ago — record-breaking timescales when you consider that in the past the development and approval process for a solution this complex, whose consequences could reverberate on a global scale, has taken between five and ten years of work. Now, with nearly 16 million confirmed cases of the new coronavirus and 300,000 deaths, the United States could not afford to wait that long.
Towards mid-November, Pfizer-Biontech published the results of its large-scale clinical trials, stating that it had achieved an efficacy level of 95 per cent with no significant differences with regard to the age or geographical origin of candidates. These reassuring figures were welcomed with enthusiasm by doctors and healthcare professionals, particularly in relation to the positive results obtained among older patients and therefore those most exposed to possible complications caused by the new coronavirus.
A few days later, on 20 November, the company applied to the FDA for rapid approval for emergency use of its vaccine, and the green light came approximately three weeks later. The first doses will be allocated to elderly people in care homes and to healthcare workers. In the early months of 2021, the over-65s, people with pre-existing conditions and essential workers will then be able to access the vaccine. It is likely that younger people or adults not at particular risk will be able to get vaccinated from the coming spring.
The United States is not, however, the first Western country to immunise its citizens against Covid-19: last week, the United Kingdom had already launched its own large-scale vaccination campaign. Following the independent streak of Brexit, the British authorities exploited a bureaucratic loophole to approve the vaccine independently of the rest of the European Union member states, which for now appear to want to await the official confirmation of the European Medicines Agency (Ema).
So, on 3 December, the Medicine and Healthcare Products Regulatory Agency (MHRA) — the relevant British body — gave the green light for the vaccine developed by Pfizer-Biontech, and just five days later Margaret Keenan, aged 90, received the first dose at the hospital in Coventry, near Birmingham. According to British broadcaster BBC, by the evening of 8 December more than 40,000 people in the UK had already received the first injection of the vaccine, without any particular complications.
Once a safe and effective vaccine has been approved, governments and health authorities must contend with another equally complex challenge: planning a transport and distribution chain capable of getting the solution to the greatest number of citizens in the shortest possible time.
One initial obstacle is posed by the conditions required for transporting the substance. To be effective, the Pfizer-Biontech vaccine must be stored at a temperature of -70 degrees. Hospitals and logistics companies are therefore equipping themselves with aircraft, lorries and freezers capable of maintaining sub-arctic temperatures throughout every stage of transit, from the manufacturing facility to the patient's arm. The first dose of the Pfizer-Biontech vaccine, moreover, provides a level of protection of just 52 per cent. For the vaccine to be fully effective, it must therefore be injected twice, three weeks apart, effectively doubling the number of doses required.
Even before transporting and distributing them, pharmaceutical companies must produce billions of doses in an extremely limited time, given that even before the official green light, states and supranational organisations had already ordered them in quantities never seen before. The European Union, for example, has already reserved 200 million doses of the Pfizer-Biontech vaccine, with the option to add a further 100 million. According to Health Minister Roberto Speranza, Italy should for now have access to around 27 million of these doses. As already mentioned, the Ema has not yet approved any vaccine but is examining data received from several companies, including Pfizer-Biontech.
Both the FDA and the Ema are currently also evaluating the vaccine developed by pharmaceutical company Moderna, which submitted an emergency use authorisation application on 30 November in the United States and in Europe the following day. The Moderna vaccine proved effective in 94.5 per cent of cases; it must be stored at -20 degrees and injected twice, four weeks apart. Both the United States and the European Union have already reached agreements to purchase 100 and 160 million doses respectively.
Another promising vaccine is the one developed by Oxford University in collaboration with biopharmaceutical company AstraZeneca. This solution has so far shown an overall efficacy level of 70 per cent, but could be simpler to produce and transport, remaining stable at temperatures between 2 and 8 degrees.
