Tue, May

Quality Assurance and Ethics of COVID-19 Vaccine Deployment

Thoughts From Afar
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Our other concern is the risk of fuelling vaccine hesitancy across the continent if the message around these expired vaccines is not communicated properly. This could be driven mainly by anti-vaccination groups and individuals who could question why other medicines are not used after their expiry date but we are being made to disregard this norm and make exceptions.

Adam Smith in “The Theory of Moral Sentiments” argues that, “the prudent man is always sincere, and feels horror at the very thought of exposing himself to the disgrace which attends upon the detection of falsehood. But though always sincere, he is not always frank and open; and though he never tells anything but the truth, he does not always think himself bound, when not properly called upon, to tell the whole truth. As he is cautious in his actions, so he is reserved in his speech; and never rashly or unnecessarily obtrudes his opinion concerning either things or persons.”

In the last few weeks, the disparity amongst lower middle income and low-income countries, as far as the logistics of vaccine deployment against SARS-CoV-2 has become apparent. Whilst Ghana received about three hundred thousand doses of the AstraZeneca COVID-19 vaccine with a fourth night to expiry but was able to deploy over 98% of the stock, the BBC reported that the World Health Organisation (WHO) had cautioned African countries not to destroy expired doses they had been unable to utilize. This appeal followed indications by Malawi and South Sudan of their intention to destroy more than 70,000 doses of the Oxford-AstraZeneca COVID-19 vaccine jab because they expired in mid-April.

These developments come at a time when there is a global constraint on vaccine supplies. However, some have objected to the position the WHO has taken emphasising that the use of expired vaccines could put people on the African continent at risk. For us, this raises issues around ethics, quality assurance and may drive vaccine hesitancy. We will now seek to address these issues.

When companies that developed these vaccines obtained Emergency Use Authorisation (EUA), the WHO was emphatic that their intention was to ensure that not a single vaccine dose went to waste. COVAX (COVID-19 Vaccines Global Access) also set a criterion for the supply of vaccines to signatory countries, one of which was for these countries to provide a deployment plan for vaccination before stocks were supplied. Therefore, one would have expected that any African country receiving vaccines would have had the machinery in place for immediate deployment. That these vaccines expired after being received makes us wonder if these rollout plans were in place. If they were not, could that not be said to have been deceitful and an ethical failure on the part of these countries?

Some have inaccurately argued that these vaccines were deliberately supplied knowing that they had a short shelf life. This to us is unfortunate. Anyone who has followed the trail of vaccine supply to Africa would have known that the vaccines in question were supplied initially to South Africa through a bilateral agreement with the Serum Institute of India (SII). They were subsequently purchased by a partnership between the African Union (AU) and the telecommunication giant MTN Group because South Africa had paused the use of the AstraZeneca COVID-19 vaccine. It is our position that just like COVAX, the AU and MTN expected that these countries had plans in place to deploy the vaccines before the expiry date. Sadly, this has turned out not to be the case.

According to the African Centre of Diseases Control and Prevention (Africa-CDC) Director John Nkengasong, only 17 million people out of 1.3 billion on the continent have received the first dose of a COVID-19 vaccine. This is less than 1% of the total number of vaccine doses that have been administered globally (1.54 billion) as of the time of writing. Whilst this is largely a result of vaccine nationalism and the failure of African countries to engage during the vaccine research and development stage, Africa cannot be seen to be dropping the ball when supplies of vaccines are received.

We are also aware that the Ghana Medical Association (GMA) has implored Ghana’s drug regulator to ensure that the yet-to be-received doses of AstraZeneca COVID-19 vaccines from the Democratic Republic of Congo are well tested as they could have potentially expired. We are in entire agreement with this call based on the factors that inform the determination of a vaccine’s expiry date; among these being the storage conditions under which these products are kept. The Africa-CDC indicates that SII has given assurance that if the storage requirements have been complied with, the vaccines should still be okay to use.

From a cynical standpoint, it could be argued that the manufacturers will make such statements. However, it can also be argued that should African medicines regulators analyse these products and quality assure them as being safe, it will be sacrilegious to destroy these vaccines. The current situation in India where most of the vaccines earmarked by African countries were supposed to be produced is instructive and should inform our approach to vaccine utilisation.

Apart from SII which is supplying to COVAX, Johnson and Johnson have also signed an agreement with Biological- E another Indian vaccine manufacturer to mass-produce its single-dose vaccine. This is the vaccine opted for by the African Vaccine Consortium. Then there is the recent agreement signed between Sputnik-V and three Indian companies (Virchow Biotech, Stelis Biopharma and Gland Pharma) to produce 652 million doses of their vaccine.  With India going through a huge upsurge in COVID-19 cases and the government placing an embargo on the export of vaccines, it is unlikely that supplies will be obtained in the coming weeks. Therefore, any doses we receive ought to be deployed judiciously.

Our other concern is the risk of fuelling vaccine hesitancy across the continent if the message around these expired vaccines is not communicated properly. This could be driven mainly by anti-vaccination groups and individuals who could question why other medicines are not used after their expiry date but we are being made to disregard this norm and make exceptions. Our view is that communication should be designed to clearly explain the guidance under which these exceptions may be granted and the benefits that could accrue. It will not be enough to disregard these concerns or expect the general public to accept explanations that are not well thought through.

We will end by reminding readers that Africa cannot afford the repercussions if their economies are disadvantaged as the world opens up. Already, countries have started laying out their plans on how global travel would emerge post the pandemic. So far, these are underpinned by the success of mass vaccination campaigns. With less than 2% of Africa’s population on track to be fully immunised, the economic risks must be a concern to us all.  This brings us back to the moral question; will it be unethical for countries that allow vaccines to expire to be refused further supplies until their deployment plans have been reviewed? The answer to this question may lie in the earlier quote of Adam Smith.

Edited by Winifred Awa

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