The Drama of Vaccine Rollout in the European Union
With 27 countries coordinating the distribution of the vaccines there’s bound to be fights, drama, and even some rebels.
What is currently available?
On 29th January AstraZeneca and Oxford officially became the third vaccine to be given conditional marketing authorization among the European Member States. Priorly, the Commission authorized the vaccines developed by BioNTech and Pfizer on 21st December, and Moderna on 6th January, following the EMA's positive assessment of their safety, quality, and efficacy. In order to accelerate the process, EMA has started a rolling review on the single-dose vaccine produced by Johnson and Johnson, in addition, Valneva’s vaccine is now in phase one and two trials.
How many doses do we have?
Contracts have been concluded with BioNTech-Pfizer (600 million doses), AstraZeneca (400 million doses), and Moderna (160 million doses); waiting for permission once proven safe and effective: Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ) and CureVac (405 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax, with a view to purchasing up to 200 million doses and with Valneva, with a view to purchasing up to 60 million doses. This means that the Commission has secured a portfolio of more than 2.3 billion doses.
How will the EU approve further vaccines?
There are many phases regarding Covid-19 vaccine development: first of all pharmaceutical quality which is carried on small-scale studies; non-clinical phase initially in vitro than in vivo; clinical trials; evaluation and decision carried out by EMA and EC; manufacturing aiming at scaling up production and lastly safety monitoring carrying out safety studies. We could divide the process into four phases: 1° laboratory test, 2° clinical trials, 3° an independent and thorough scientific assessment by the European Medicines Agency, 4° market authorization by the European Commission. Once it was proven safe and effective on Ferrets, mice, and/or monkeys, three phases of clinical trial begin: I. looking at safety possible immunity response and establishing the correct dosage on a small number of healthy volunteers (20/50); II. looking at the vaccine’s efficacy on humans involving a hundred volunteers; III. looking at efficacy on a much broader scale involving several thousand volunteers. Because of the severeness of the Covid-19 pandemic, these phases overlapped in order to speed up the approval. As pharmaceutical companies gather data, the vaccine is then submitted to regulators for approval where experts analyze its efficacy, stability, safety, quality, and manufacturing process.
What certainly plays a major role is an unprecedented pooling of expertise to reduce timelines, the Committee for Medicinal Products for Human use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC) are responsible for advising EMA. Another key element is what is referred to as “Rolling reviews”, by constantly providing the EMA with data, several rolling review cycles can take place simultaneously.
Are all the Vaccines created equal?
Pfizer/BioNTech shows up to 95% efficacy after two doses, costs €17euros for each dose, has to be stored at -70° C, to be kept up to six months, then stored in a normal fridge for up to five days.
Moderna shows nearly 95% efficacy after two doses, costs €28 for each dose, could be stored at around -20°C
Whereas Oxford AstraZeneca is between 62% and 90% effective, costs €3.40, could be stored in a normal fridge (3–8°C)
Johnson&Johnson is producing a single-dose vaccine shown to be 66% effective against Covid-19 and could be stored in a standard fridge.
What is the hold-up?
Many countries saw their vaccination program being shattered as pharmaceutical companies reviewed their distribution capacity.
The head of BioNTech, Uğur Şahin, said the delay was because the EU wrongly assumed several different vaccines would be ready at once and therefore spread its orders. He said the company was ramping up manufacturing capacity. But vaccinations in parts of Europe were paused after Pfizer temporarily cut deliveries, to increase capacity at its processing plant in Belgium.
The bloc looks set to receive only a quarter of the 100 million doses it had been expecting from pharma company AstraZeneca by the end of March; Vaccine deliveries from another pharma giant, Pfizer, have also slowed down temporarily, while the firm says it’s adjusting production methods. AstraZeneca, BioNTech, and Pfizer have European production sites, whereas Moderna completes its vaccines for countries other than the US in Spain, although the vaccine itself is produced in Switzerland, which is not an EU member.
The impact on individual countries
Italy has been told to expect a 20% cut in the doses of Pfizer-BioNTech vaccine next week — it has already seen a 29% dip this week — and Rome is considering legal action. Special Covid commissioner Domenico Arcuri says jabs fell from 80,000 a day to an average of 28,000 last Saturday. Some Italian regions have seen a 60% fall in doses.
Germany, where BioNTech is based, has had several states struggle with vaccine deliveries. North Rhine-Westphalia, in the west, halted jabs in hospitals on Tuesday and paused first vaccinations in nursing homes too. Second vaccinations are continuing but special centers for the over-80s will not open now until next month. Authorities in and around the Spanish capital Madrid have temporarily stopped vaccinating healthcare personnel this week, saying they had only received half the doses they were expecting. The national government is rationing distribution until Pfizer’s deliveries improve. Spain reported a record 44,357 cases in one day on Thursday.
Romania has warned that its vaccine stocks could be down to almost zero by the end of the first week of February. The Czech government has warned that the reduction in the distribution has created “huge complications”.
Poland, which began by vaccinating healthcare workers and moved to care homes this week, saw a 50% drop in the number of vaccines delivered this week. Ministers say they have been promised normal service by mid-February. If that is not the case, Warsaw says it would consider legal action.
Some countries are tired of waiting
Hungary decided to issue a decree calling for a green light for any vaccine that had been administered to at least 1 million people in at least three other countries, ending in approving the inoculation of Sputnik V at first. As China has been heavily marketing its two vaccines (made by Sinovac and Sinopharm) with millions of doses shipped around the world to developing countries, on January 29th Hungary became the European Union’s first member to approve Sinopharm Covid-19 vaccine for five million doses. As of today, only 1% of the population has been vaccinated and 38% want to be vaccinated but not with the Russian or Chinese vaccine.
The Informer, a Serbian national tabloid, announced that 38% of those who have applied to take the shots favor the Russian, while 31% want the Pfizer-BioNTech version, underling a historical division among pro-Russians and pro-Westerners in Serbia.
In neighboring Bosnia-Herzegovina politics are a crucial factor, as the Serb-run half appeared set to opt for the Russian vaccine, while the Bosniak-Croat part likely turn to Western ones
In conclusion, the various vaccines are not up against each other, they are all going to play a key role when it comes to ending this pandemic.
