Issue link: https://maltatoday.uberflip.com/i/1324024
8 maltatoday | SUNDAY • 3 JANUARY 2021 INTERVIEW Raphael Vassallo rvassallo@mediatoday.com.mt Vaccine concerns are understandable, As of this week, Malta has started to ad- minister its first batch of the much-an- ticipated COVID-19 vaccine. Here as elsewhere, there are concerns about the speed with which this vaccine was de- veloped and approved. Are these con- cerns justified? The concerns, in themselves, are per- fectly understandable. If you look at the normal timeframe in which a new vaccine gets approved, it usually takes around 10 years. In this case, the vaccine was pro- duced and manufactured in about 11 months. So obviously, it raises the ques- tion of whether there was enough scru- tiny to ensure that the vaccine is safe and effective in the first place. There is no de- nying that. However, if you look more closely at the process itself, you will see that this did not come about at the expense of efficacy and safety. There are a number of issues which have resulted in this contraction. Starting with the pandemic itself: which, as the name implies, involves the whole world. As a result, there was a huge global effort - featuring unprecedented collab- oration between governments, manufac- turing companies and NGOs – to try to suppress this disease. So where, usually, a lab would work on a new vaccine in isolation – and try to keep it secret from other labs, for obvious rea- sons – this did not happen, in this case. Moreover, the usual process is for a manufacturing company to go through a number of phases, involving volunteers in increasing numbers. In Phase One, there might be 10 volunteers; in Phase Two, a hundred; and in Phase Three… tens of thousands. Organizing these trials, therefore, in- evitably involves huge amounts of mon- ey. So what usually happens is that, if a new vaccine shows promise at the clinical (lab-based) stages, the company will have to first seek financing. That, alone, usual- ly takes a couple of years. In this case, however, world govern- ments were under intense pressure; and they decided to invest the necessary money - with no guarantees attached - to make sure that the manufacturing com- pany would not run into financial prob- lems. The EU alone invested €3 billion; the USA, €5 billion… apart from other countries, naturally. This, too, shortened the process considerably… What about the medical studies them- selves, however? How is it possible for a process which normally takes 10 years, to be concluded in 11 months… without taking short-cuts? There are other factors involved: and one of them (ironically, perhaps) is the extent of the disease itself. To conduct large-scale, robust studies - and to produce positive results – you not only need huge amounts of volunteers; but also, a huge number of infections. If, for instance, we are dealing with a disease that only affects five people a week… it would take a number of years to conduct the necessary tests, on tens of thousands of people, to ensure a positive outcome. But because this pandemic is causing millions of infections every week, this pro- cess was considerably reduced. There are so many infections, that you can reach the significant amount of volunteers, need- ed to come up with a significant answer, within a much shorter time-frame… Another factor concerns the 'rolling review'. Once the necessary studies have been conducted – and thousands of pag- es of data have been compiled – what usually happens is that the data is passed on to the regulatory agencies, at the end of the entire process. In Malta, the regulatory body would be the Medicines Authority; but interna- tionally, the three main ones are the Food and Drug Administration; the European Medicines Agency; and the Medical and Healthcare Regulatory Agency. Under normal circumstances, it would take at least a few years for these agencies to be able to come up with a final 'Yes' or 'No'. This is because the standard proce- dure is for all the data to be collected first, before being submitted for approval. In view of the urgency in this case, how- ever, the agencies decided to accept data, not at the end of the process… but as it came out of the studies, phase by phase. As the data is produced, it is being imme- diately passed on to the regulatory agen- cies so they can start working on it. So it's a rolling review… it's not a case that the reviews are not taking place; they are, as they should be. But instead of waiting for all the data to be collected… the data is being analysed, step by step, as it emerges. Lastly, what happened in this case – which doesn't happen usually – is that, because the companies involved had ac- cess to large sums of money, they started to produce the vaccine, and to stockpile it in their stores, before getting final ap- proval by the authorities. For obvious reasons, this has never happened before; because it's a huge financial risk. But this time round, the money they were risking was not their own. It was our money… So if I'm understanding correctly: had this vaccine not been approved, all those stockpiled drugs would have gone to waste… Exactly. They would have to be de- stroyed. However, the corollary to this is that: if the vaccine was found to be safe and efficacious – as, in fact, it was – the producers would be in a position to start rolling it out immediately. And this is precisely what happened. So when you consider all those factors, it explains why the process has been con- tracted in such a way as to not impact the The new COVID-19 vaccines have raised hopes for an eventual end to the crisis; but have also been met with scepticism. Dr CHARLES MALLIA AZZOPARDI, head of Mater Dei's Infectious Diseases Division, allays fears that the approval process may have been rushed