Federica Santoro 0:10

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center where we explore current issues in pharmacovigilance and patient safety. This episode is part of the Uppsala Reports Long Reads series, where we select the most topical stories from our magazine, Uppsala Reports, and bring them to you in audio format. Our pick for today is an article that appeared online earlier this month in May 2021. Its title is Substandard and Falsified COVID-19 vaccines in the Americas. Can vaccine equity help? COVID-19 vaccinations are picking up speed in many wealthy countries. But citizens of lower-income countries still face a long wait. And in any situation where demand exceeds supply, black markets tend to form. Danini Marin is a drug regulatory specialist in Belize. In Uppsala reports, she makes the case for pursuing vaccine equity measures to help mitigate the risk of substandard and falsified vaccines. Right after the read, I'll ask Danini a few questions about equitable distribution and trust in vaccines. So make sure you stay tuned until the end. But first, let's hear the article. Here's Substandard and Falsified COVID-19 vaccines in the Americas, written by Danini Marin and read by me, Federica Santoro. It has been more than a year since the SARS-CoV-2 virus outbreak was declared a pandemic by the World Health Organization. Around the world, normal life was appended in the face of the new disease caused by the virus COVID-19, with a worryingly high fatality rate and no known cure. Alongside several emergency use authorizations issued by national regulatory authorities for experimental COVID-19 treatments, the race for a vaccine began. The emergence of vaccine candidates prompted countries to improve their readiness for COVID-19 vaccine introduction. WHO and other national regulatory authorities began granting emergency use authorizations for COVID-19 vaccines, a momentous event in science history. And as the strong results of the early vaccination programs became obvious, expectations for COVID nineteen vaccine deliveries grew around the world. But the allocation of doses began to hit challenges as vaccine manufacturing capacity became overwhelmed. Now, questions about the equitable worldwide distribution of vaccines grow louder, and many countries still wait on the deliveries that would allow them to begin vaccinating their people. During this pandemic, the challenge of tackling substandard and falsified medical products has grown. Unauthorized products have been promised as COVID nineteen remedies or cures to populations that yearn a return to normal. The introduction of COVID-19 vaccines has been taking place against this backdrop, and the unmet demand for vaccines, along with continued delivery delays, have created a fertile environment for substandard and falsified COVID-19 vaccines to arise. At the end of the first quarter of 2021, the WHO resource COVID-19, landscape of novel coronavirus candidate vaccine development worldwide, listed 83 vaccines in clinical development. Several of these have made their way to the Americas, such as AstraZeneca, CanSino, Coronavac, Janssen, Moderna, Pfizer Biotech, Sinovac, and Sputnik V. The United States has granted emergency use authorizations to Pfizer BioNTech COVID-19 vaccine, Moderna COVID 19 vaccine, and Jansen COVID 19 vaccine. Brazil has granted such authorizations to AstraZeneca Oxford, Covey Shield, Pfizer BioNTech, and Sinovac. Mexico has provided them to AstraZeneca Oxford, Cancino, Pfizer BioNTech, Sinovac, and Sputnik V. Other countries do not provide national emergency use authorizations, but rely on WHO ones. Although there are numerous vaccines being developed, a limited number have been authorized for emergency use. While the Americas have confirmed more than fifty-five million cases of the virus, the number of vaccine doses arriving to the region remains insufficient to attain herd immunity. Furthermore, the delivery of doses to the Americas has not been proportional. Countries like the United States have administered over 100 million doses, while others have not yet received any doses. While many countries await the arrival of the COVAX vaccines, others, like Barbados, opted to engage in bilateral agreements with countries such as India to receive their first doses. By the end of the first quarter 2021, data from COVAX indicated that over 2.4 million doses had arrived in 13 countries in the Americas, revealing that improved access to the vaccines needs to be achieved in the region. Global data show 54 incidents of COVID-19 vaccines being substandard, falsified, or diverted from the legal supply chain, according to the report issued by the Infectious Disease Data Observatory on 18th March 2021. Some of the reported incidents include the identification of falsified batches of vaccines, the sale of falsified vaccines via the internet, theft of authentic COVID-19 vaccines from authorized vaccination facilities, and vaccine cold chain breakdown. Of particular concern, WHO has issued a medical alert on a falsified lot of Pfizer BioNTech in Mexico. In response to the problems, Latin American countries have embarked on media campaigns to fight these compromised vaccines and to reiterate to the public that legitimate vaccines are only being administered through the health authorities. Other sanitary alerts in the Americas include unauthorized commercialization of COVID-19 vaccines via the Internet. Substandard and falsified vaccines pose a threat to any region, country or person, increasing the risks of adverse events of special interest or ACs, and adverse events following immunization or AFEs. Colloquially, people know ACs and AFEs as side effects, such as fever, muscle pain and headache among others, which can be associated with authentic vaccines. However, substandard and falsified vaccines available via unauthorized channels in the supply chain can pose greater risks such as hospitalization and death. They can also give a false sense of security to citizens and can contribute to a wider spread of the virus as persons administered substandard and falsified vaccines may not present the required level of protection against COVID-19. While vaccine hesitancy is well recognized as posing a threat to the success of public vaccination programs, less well known but equally concerning is a threat posed by individuals or companies willing to take advantage of the demand for vaccine access. Further studies on substandard and falsified COVID-19 vaccines will be required to assess the specific impact of these products on the health of the population. At this time, enforcement agencies like Interpol have called for law enforcement to remain vigilant on the issue of substandard and falsified COVID-19 vaccines circulating in the markets and sought joint efforts along with health authorities. Clearly, substandard and falsified COVID-19 vaccines are a potential health risk to the population. At the same time, a call for vaccine equity has been made by countries, agencies, and other organizations in the region. The deployment strategy that stands out in these countries includes a phased vaccination approach. This translates into persons waiting in line for their turn. Beyond this, the time lag that occurs when countries wait to receive sufficient vaccines for their population can become lengthy. The vaccines are administered mostly by the health authorities and are free of cost, but the logistics and coordination to reach from urban to rural areas may also contribute to the added weight. Furthermore, the cold chain must be maintained to prevent compromising the quality of the vaccines. Vaccines also need to be stored in safe locations where security can be provided, such as surveillance cameras, to prevent the diversion of these products and reduce the circulation of substandard vaccines in the market. These are just a few critical aspects of the deployment process. But if there is increased access to COVID-19 vaccines, the weight can shorten and the demand can be attenuated, reducing the incentives for the supply of substandard and falsified vaccines. Furthermore, if health authorities administer doses to their people at a higher rate, they can reduce the risk of people being exposed to substandard and falsified vaccines. Expanded access of the vaccine from public to private sector can also increase vaccination coverage and would be viable when manufacturers increase production and reach to all countries. Time is valuable and vaccine access is essential to move towards a post-COVID-19 era. May history remind us that vaccines don't work, vaccinations do. Thank you so much for joining us on Drug Safety Matters, Danini. It's a pleasure to have you here today. So in your article for Uppsala Reports, you argue that to limit the spread of substandard and falsified COVID-19 vaccines, we need to make sure that the good stuff, so the authentic vaccines, are distributed fairly. But that may sound easier said than done. In your opinion, how can we achieve vaccine equity?

SPEAKER_00 11:34

We need to improve on the overall global commitment for the equitable access of COVID-19 vaccines. We must realize that vaccine nationalism only benefits a nation, but to achieve a global health and economic recovery, we need the COVID-19 vaccines to reach all nations. We know that the virus has made its way around the globe, including the new variants, which cause additional challenges in moving to a post-COVID era. Therefore, the reason that I say that we need commitment of all nations is because we are seeing that the most developed have better access to COVID-19 vaccines at the moment, but they would need to provide support to the low and medium income countries for the greater good of all. In so doing, we would also need coordinated efforts to increase the production capabilities, address the raw material and other supply shortages that we're seeing, overcoming the challenges to reduce the delivery times of the vaccines to the countries, and ensure that the final products do reach destinations. We also need to remain hopeful that the vaccine candidates that are on the pipeline are successful.

Federica Santoro 13:06

Now let's talk about COVAX for a second. You mention this international effort in your article, and this is an initiative co-led by WHO, the Coalition for Epidemic Preparedness Innovation, CEPI, and GAVI, the Vaccine Alliance. And there's also the UN Children's Fund, UNICEF, as a key implementation partner. Now COVAX was set up to try to ensure fair access to vaccines among rich and poor nations, but despite that, the situation remains uneven, as you point out in your article. So why has the supply through COVAX been so slow?

SPEAKER_00 13:49

Although COVAX has shipped over 59 million COVID-19 vaccines to 122 participants, that's their latest data. The forthcoming information on this subject indicates that it is due to increased demands in the countries of manufacturers, such as India, also the shortage of raw materials, and also the agreements between countries, individual nations, and manufacturers. But just recently, a COVAX manufacturing task force has been established to identify and resolve the issues that hinder the equitable access through COVAX. And we remain hopeful that we can close the gaps that the world needs to have this equitable access to COVID-19 vaccines.

Federica Santoro 14:39

And we really hope so. Let's talk about the market for substandard and falsified COVID-19 vaccines. Who is fueling the business? Do we know? So is it people with an established profile in the world of fake medicines, or is this a different type of criminal who sort of jumped on the opportunity of making a profit from the pandemic?

SPEAKER_00 15:04

It is difficult to track the background of every single individual that is involved in the substandard and falsified COVID-19 vaccine business. However, there are some that are not new to the fake medicines business, as well as others that are involved in organized crimes that we are aware of. What we do know is that they are being identified in all corners of the world and they're working throughout the nations, crossing borders, ensuring that their supply chain or their networks are able to maybe not supply but to advertise these fake vaccines so that people fall for their scams and other related activities.

Federica Santoro 15:58

And interestingly, we covered fake medicines, the topic of fake medicines, in the very first episode of this podcast. And at the time, my guest was a former Interpol officer, Aline Planson, who'd been working in the field of substandard and falsified medicines and trying to fight them, obviously, for years. And one of the things we discussed during that interview is how fake medicines certainly damage people's health, but also, and that's something not everyone thinks about, is that they corrode people's trust in medicines and the healthcare authorities. So, in your opinion, how will the spread of fake COVID vaccines impact people's trust in vaccination?

SPEAKER_00 16:44

The spread of substandard and falsified vaccines will most likely negatively impact people's trust in vaccines, as their expectations of desired effects will not be achieved most of the time. For instance, reducing the probability of getting infected with COVID-19 or getting mild symptoms of the disease. On the other hand, the use of SF COVID-19 vaccines have the potential to cause unwanted or unknown adverse events or side effects, causing people to believe that it is attributed to the authentic vaccine which authorities have approved as safe and effective to use.

Federica Santoro 17:40

Where they encouraged a lot of different players, regulatory authorities, healthcare professionals, vaccine distributors and suppliers, and the public to be extra vigilant. And that's good advice. But what is your advice to our listeners? What can people do to help curb the spread of fake COVID vaccines?

SPEAKER_00 18:02

My advice to everyone is to remain informed by listening to trusted sources, such as your ministries of health, your regulatory authorities, and any other official information from your governments as to where you can get vaccinated. Also, do not purchase vaccines from any websites, including those that become available in social media, as you run the risk of purchasing fake COVID-19 vaccines since none of those vaccines that have been approved are available to be sold online at this moment. If you're not sure as to whether or not your vaccine is authentic, you can call the COVID-19 hotlines available in your countries to seek advice. If you believe that you have fallen victim of a COVID-19 vaccine scam or similar, contact your nearest police station or authorities. And very important, if you are manifesting any adverse events, report it to the nearest pharmacovigilance center in your country.

Federica Santoro 19:08

Thank you for that solid advice. And thank you so much for joining me on the show. Is there anything else you'd like to add?

SPEAKER_00 19:18

The only thing that I would like to add is that if you have the opportunity to get vaccinated, do so. Because vaccines don't work, vaccinations do.

Federica Santoro 19:28

Thank you, Danini, for making time to talk to me today. It was a pleasure. It was a pleasure as well. That's all for now, but we'll be back soon with more long reads as well as our usual in-depth conversations with medicine safety experts. If you'd like to know more about substandard and falsified COVID-19 vaccines, visit upsalaports.org or check out the episode's show notes for useful links. In the very first episode of this podcast, Fighting the Fakes, we spoke to former Interpol Officer Aline Planson about the deadly trade of fake medicines. So if you'd like to know more, we really recommend you go back and listen to that. For more stories like this one delivered straight to your inbox every month, sign up for our free newsletter at upsala reports.org slash subscribe. And of course, if you don't want to miss future episodes of Drug Safety Matters, do subscribe to the podcast in your favorite player. And while you're there, we'd love it if you could leave us a review so other listeners can find us. If you have any comments or suggestions for the show, you're welcome to reach out on social media, look for Uppsala Monitoring Center on Facebook, LinkedIn or Twitter, and come talk to us there. For drug safety matters, I'm Federica Santoro. I'd like to thank Danini Marin for the interview, Matthew Barwick for post production support, and of course you for listening. Till next time.