the great waste of expired vaccines

More than 240 million doses of anti-Covid vaccines have exceeded their expiry date since the start of the vaccine campaign. And this, only in the national stocks of the rich countries. Of these, 73% are doses of Pfizer, the most widely used vaccine in northern countries. Second most wasted vaccine: AstraZeneca, which accounts for 18% of all expired doses. In France, 218,000 doses, only of AstraZeneca, would thus have expired, indicates the general direction of health.

This assessment, carried out by the health data analysis company Airfinity, based in London, represents only the tip of the iceberg: in the absence of information on the doses given to poor countries, this first inventory is largely underestimated. It is henceforth ” highly probable “believes Sarah Harper, its spokeswoman, that the number of expired doses in poor countries exceeds the already maddening toll in rich countries.

And for good reason: the latter have massively disposed of their excess doses since October 2021, sometimes just before they expire, through bilateral arrangements or through Covax, the international program supposed to provide vaccines to countries in development. During the month of December 2021 alone, more than 100 million doses donated to Covax were finally refused by the beneficiaries because of their too short remaining life…

“Too often, countries receive unscheduled deliveries of doses nearing expiry, with far too little transparency on when the doses arrive, what vaccine and in what quantity”lamented Tedros Ghebreyesus, the director general of the World Health Organization (WHO), on December 6, 2021.

“These last-minute donations are adding considerable stress to countries that are already resource constrained and facing other health and humanitarian crises.also noted, at the end of December 2021, the Independent Vaccine Allocation Group (IAVG), which manages distribution for Covax. This way of doing things is not acceptable and must stop.” called its twelve international members, who have so far remained very discreet.

Open landfill

An example ? In October 2021, Nigeria accepted several donations totaling 2.6 million doses of AstraZeneca, including 500,000 from France, with just four to seven weeks of shelf life remaining. “We had no choice but to accept them because there were no more accessible doses on the market”, recounts Faisal Shaibu, Director of Nigeria’s National Primary Health Care Development Agency.

The National Medicines Agency (NAFDAC) then immediately proceeds to a series of tests “to prove that these vaccines were really of quality”, explains its managing director, Mojisola Christianah Adeyeye. The batches are released nineteen to twenty-one days later, then transported across the country.

According to a document consulted by The world, only 1.53 million doses could be injected within the time allowed. The others, more than 1 million doses, were destroyed on December 22, 2021, buried by bulldozer in the huge open dump of Gosa, located about 10 kilometers from the center of Abuja. Which, beyond waste, poses another problem: “By simply burying the doses underground, there is a risk of soil and groundwater pollution,” reports Laurent Wilmouth, director general of the Cyclamed association, charged by the general directorate of health with the elimination of expired, started or empty Covid-19 vaccines. In France, this type of waste is incinerated.

Legal and logistical obstacles

According to a joint investigation by The world and an international team of journalists, the case of Nigeria is far from an isolated incident. After purchasing most of the world’s production at the start of the epidemic, rich countries found themselves with vaccine surpluses without having anticipated the legal and logistical obstacles associated with donations or resales.

“Manufacturers tend to dictate terms to EU member states and donor countries, making it nearly impossible to respond quickly to the demand for international aid,” revealed the German Secretary of State for Health, Thomas Steffen, in October 2021, in a letter intended for Sandra Gallina, chief negotiator in Brussels. Among these conditions: the contractual obligation of the Member States to obtain the written consent of the manufacturers before any transfer of vaccines. Additional obstacle: the extremely short lifespan of these vaccines, between six and twenty-four months, compared to more than three years in general for other vaccines.

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At the time of their homologation during the winter of 2020-2021, “the stability data of marketed products were limited”, recalls the European Medicines Agency (EMA). In the case of Vaxzevria, AstraZenca’s vaccine, the stability studies were based solely “on three clinical trial batches, manufactured using a manufacturing process prior to that used for commercial products”even specifies the agency.

Given the urgency, these products were nevertheless authorized, but with a specific obligation to provide additional studies to confirm the shelf life, initially set at four and a half months for the Janssen vaccine, six months for the of AstraZeneca and that of Pfizer-BioNtech and seven months for that of Moderna (the latter two at much lower temperatures than the others, between − 60 ° C and − 90 ° C). Alongside this obligation, there is also a “recommendation” to submit a request for an extension of the life of the product, “backed by real-time data”.

“The EMA has been heavily involved with manufacturers to encourage them, on a regular basis, to request an extension of the lifespan of their product”, indicates the agency, while specifying that it is up to the companies to decide “if and when” they wish to submit such a request. Among the first four manufacturers authorized to market their vaccine, AstraZeneca is the only one not to have followed this recommendation. Its product therefore remained blocked for the initial six months, while the others were able to add two (Moderna), three (Pfizer-BioNTech) and even seven additional months (Janssen) since their approval.

Does this mean that Vaxzevria is the only vaccine not to be stable beyond six months? Nothing is less sure. In May 2021, the Canadian Medicines Agency decided to add an additional month delay to three batches for which the expiry date was imminent, after receiving from AstraZeneca “product stability data and data from mathematical models demonstrating that the quality, safety and efficacy of these batches would be maintained for an additional month, seven months in total,” says Health Canada.

In the case of Nigeria too, the company had proposed in the fall of 2021 to add three months of life, relying on ” additional data “. A proposal refused by the authorities of the country: “Nigeria does not dispense vaccines whose validity is extended beyond the expiry date indicated on the label”, informed the Ministry of Health.

Even more recently, the 1^er March 2022, when six million doses of Vaxzevria donated by rich countries to Indonesia were about to expire, the government of that country agreed to extend the expiry date to nine months, relying, there too, on “new efficacy data”.

A complex process

But that’s not all: as part of an agreement with AstraZeneca, the Serum Institute of India produces in its Indian factories a vaccine in all respects equivalent to Vaxveria called Covishield (not approved in Europe). This product now has a shelf life of nine months. “On June 25, 2021, we approved the six to nine month shelf life extension of the Covishield vaccine following the application filed by Serum Institute of India,” explains the WHO, which specifies: “So far, AstraZeneca has not submitted a request to extend the shelf life of its vaccine, despite [nos] encouragement. »

Questioned, the Swedish-British industrialist replies that such a request requires “a complex process involving the collection of real-time data from twenty manufacturing partners to ensure that all shelf life extensions meet the highest quality standards”. Requests are easier “when few manufacturing sites are involved”, he also points out.

“This file seems to me to be one more example of the limits of the system where the drug agencies only react to the action of the companies, reacts Bruno Toussaint, former editorial director and member of the editorial staff of the independent medical journal Prescribe. If the firm does not act, the authorized expiry period does not change. »

For Enrica Altieri, who headed the research and development department for human medicines at the EMA until June 2020, “we have to ask ourselves how real are these label shelf lives”. According to this Italian specialist in the pharmaceutical industry, ” companies generally try to have the shortest possible shelf life for two main reasons. The first is that studying takes time (…). And the second is that when a medicine expires, we throw it away and buy a new one. This is the classic business reason”. Especially since in the case of AstraZeneca, the doses that expire today had been purchased at cost. Since November 2021, the vaccine can be sold at a profit.