Pharmaceuticals and Vaccines

Beach Gray, PhD, is a Senior Open Source Analyst at Novetta, specializing in Russian disinformation and media influence. Neil Edwards is an Open Source African Media Analyst at Novetta. On December 3, a vaccine produced by Pfizer, BNT162, became the first COVID-19 vaccine to receive authorization in the United Kingdom for distribution. The United States is conducting its own internal review before granting emergency authorization. However, even if the vaccine receives authorization in the United States and elsewhere, questions remain over the public's willingness to be inoculated. Surprisingly, in Africa, perceptions of Russia’s flagship vaccine, Sputnik V, are largely positive, despite it having not undergone the rigorous clinical trials that other vaccines have. In Africa, public opinion is often difficult to measure, whether due to conflict, undemocratic regimes, or a lack of administrative capacity. To work around these challenges, Novetta collects and curates traditional and social media data from fifty-four African countries. Novetta’s Rumor Tracking Program (RTP) was developed specifically to track misinformation and disinformation associated with COVID-19 and vaccines in development. The RTP reveals that the Pfizer vaccine, compared to other vaccines in phase III clinical trials, has maintained the highest rate of positive press and social media coverage across Africa since April: 52 percent of extracted quotes from traditional and social media were favorable to the Pfizer vaccine. The positive public perception of the Pfizer vaccine was largely driven by the uptick in discussion on November 9—the day Pfizer announced its early findings—suggesting that the vaccine could be more than 90 percent effective. Recent news of the Moderna vaccine’s effectiveness resulted in a similar surge of positive sentiment in African media. Curiously, in early November—before Pfizer’s announcement—Russia’s Sputnik V was the vaccine with the second-highest proportion of positive quotes about vaccine development. From the day Russia first announced its vaccine on August 11 to Pfizer’s announcement of its own vaccine’s efficacy on November 9, African media coverage of Sputnik V was largely positive (56 percent). After Pfizer, Moderna, and Oxford-AstraZeneca released their clinical trials' findings, these vaccines surpassed Sputnik V in positive media perception. However, the Sputnik V vaccine remains the most discussed vaccine in African media and boasts the second-lowest negative perception (11 percent). A subset of the RTP concerns just media coverage of clinical trials. Despite Sputnik V’s questionable efficacy—early trials included only seventy-six participants in two hospitals—the vaccine had the second-highest rate of positive quotes (66 percent) in African media coverage specifically about clinical trials as of December 4, trailing only the Moderna vaccine (87 percent) in positive media coverage. Rates of positive clinical trial coverage of potential vaccines from Johnson & Johnson (62 percent), Pfizer (52 percent), and Oxford University (35 percent) were all lower than Sputnik V—despite undergoing far more rigorous clinical trials. Non-Russian media’s support for the Sputnik V vaccine and its clinical trials originates in large part from a targeted Russian disinformation campaign in countries with former and current ties to Russia and the Soviet Union. Sputnik V seems to be as much about public relations and Russian soft power as about stopping the spread of COVID-19. Kirill Dmitriev, chief executive officer of Russia’s Direct Investment Fund (RDIF), the state-run sovereign wealth fund, explained the vaccine’s name choice, stating “we understood that there would be lots of skepticism and resistance to the Russian vaccine for competitive reasons; therefore, there was a decision to call it a Russian recognizable international name.” (The name Sputnik is a reference to the first satellite launched into space.) The disinformation campaign started on August 11, when the Russian Ministry of Health approved Sputnik V as the world’s first vaccine against COVID-19. The approval itself was, by scientific standards, misleading, since the vaccine had not begun phase III clinical trials. However, Russia’s Ministry of Health doubled down on September 4, claiming it had manufactured the “best vaccine in the world” against COVID-19. President Vladimir Putin made a similar claim during West Africa’s Ebola outbreak, stating that Russia had invented a more effective treatment than any other available globally. To shape the global discussion of Sputnik V, Russia used a familiar tactic: publish breaking stories that will be widely covered in international media. Russia’s Ministry of Health, unconstrained by international scientific standards, claimed the vaccine’s overwhelming effectiveness. The Russian government then used such flimsy data to back up proclamations that governments worldwide had expressed interest in the Sputnik V vaccine. With its messaging, Russia specifically targeted countries—such as Mozambique, Nigeria, and South Africa—where it competes with Western and Chinese influence. To underline the vaccine’s apparent efficacy, the Russian News Agency stated that as of December 2, one hundred thousand high-risk individuals had already received Sputnik V vaccinations in Russia. One of the RTP’s most interesting findings was that before Pfizer’s announcement on November 11, the main driver of Russian disinformation throughout Africa was Russian President Vladimir Putin, who accounted for about 5 percent of quotes in traditional media—more than any other person. The next most quoted speaker is the Russian Minister of Health, Mikhail Murashko, at 1.4 percent. In coverage of other vaccines, meanwhile, the most quoted speakers have been heads of national health ministries or chief executives of companies producing vaccines, rather than heads of state. Putin is front-and-center in the disinformation campaign because his cult of personality helps quell dissent from the scientific community. Putin himself announced the vaccine approval and, as a result, is quoted heavily in Sputnik V’s media coverage. Notably, in 69 percent of monitored traditional and social media outlets and 18 percent of quotes from Putin, the president mentions the administration of the “safe and effective” vaccine to one of his adult daughters—publicly endorsing the vaccine by putting his own family at risk. Sputnik V’s popularity in African media is troubling, considering the vaccine has not undergone the same rigorous clinical trials as other contenders. The success of Russia’s disinformation and public relations strategy stems from the Kremlin’s ability—and willingness—to disseminate and emphasize its message about Sputnik V’s effectiveness. To counter Russian disinformation in the vaccine space, pharmaceutical professionals and politicians should devote more attention to highlighting the importance of rigorous clinical trials and explaining how vaccines in phase III trials meet acceptable standards. By emphasizing science rather than personally endorsing a “winning” vaccine, the vaccine debate can be re-framed in a way that more effectively combats Russian disinformation.

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Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The trial started in Johannesburg, the commercial capital, and Pretoria, the national capital, in Gauteng province, and will gradually spread to other parts of the country. In Johannesburg, some participants are residents of Soweto township. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate two thousand South Africans. It is appropriate that South Africa host the vaccine trials. It has by far the most developed medical infrastructure in Africa and a tradition of medical innovation. The Groote Schuur Hospital in Cape Town was the site of the world's first heart transplant, now a generation ago. It is winter in the southern hemisphere, the season in which influenza of various types are most prevalent.  Trials of the Jenner Institute’s vaccine are taking place in Brazil, South Africa, and the United Kingdom; the other trials also appear to have begun on June 24. According to the WHO, there are 220 vaccine candidates in development. Thirteen are in clinical trials: five in China, three in the United States, two in the United Kingdom, including that developed by the Jenner Institute, and one each in Australia, Germany, and Russia. The Jenner vaccine is currently manufactured in the United States; production is expected to shift to the Untied Kingdom in the autumn. South Africa is the African country that has been hardest hit by the virus, up to now. As of June 24, there were 111,796 cumulative cases—one-third of the continent's reported disease burden—and 2,205 people have died from the virus. About 57,000 have recovered, so there are about 53,000 active cases. South Africa has by far the most extensive testing regime of a major country in Africa, with 1.4 million tests conducted so far out of a population of 58 million. The WHO recently announced that all African states have the laboratory capacity to test for the virus, though others still lag far behind South Africa’s testing ability. Nigeria, for comparison, has conducted just 122,155 tests out of a population of about 200 million, with 22,020 confirmed cases as of June 24. In the United States, 30 million tests have been conducted out of a population of 328 million, with about 2.9 million positive tests reported. The government of President Cyril Ramaphosa has aggressively imposed various protocols to control the spread of the disease. Enforcement, however, has resulted in instances of police brutality which undercut popular support. In response, some of the restrictions have been lifted. South Africa's official statistics are credible. However, those of other African countries are less so and many observers estimate that cases are under counted. Hence, it is hard to know the true proportion of Africa’s COVID-19 cases made up by South Africa. What is clear is that of the continent's largest states—Nigeria, Ethiopia, and the Democratic Republic of Congo—South Africa's efforts to control the virus have been the most extensive.

Emily Kaine, MD, is the senior vice president for global health at the U.S. Pharmacopeia. Jude Nwokike is a vice president for global public health at the U.S. Pharmacopeia. The COVID-19 pandemic has caused massive disruptions to global supply chains. Africa is particularly vulnerable with respect to pharmaceuticals, both because between 70 and 90 percent are imported and because the continent generally lacks the political sway and bargaining power of other regions. In the short-term, the most acute issue is the need for huge quantities of quality-assured protective equipment, tests and medicines to treat the symptoms of COVID-19. Significant shortages of other essential medicines could materialize. With access to such essential medical products across the continent challenged, there has been a commensurate uptick in substandard and falsified products related to the testing or treatment of COVID-19.  But many countries in Africa have underutilized capacity to produce quality-assured, essential pharmaceutical products locally. In Nigeria, one of the countries with the greatest potential for rapidly scaling up production, pharmaceutical manufacturing production currently utilizes around 40 percent of actual installed capacity. Manufacturing output remains lower than its potential in part due to inconsistent demand, challenges in sourcing active and raw ingredients, unfavorable market conditions, and a lack of available investment to scale up operations, modernize equipment, and resolve local infrastructure limitations. Here are some ways to make use of this potential.  Insufficient knowledge about the real capacity of local manufacturing sectors, sources of component parts, and expected market demand is hindering efforts to make use of local excess capacity. Pharmaceutical manufacturing associations—along with market intelligence firms, multilateral agencies, and international donors—should lead a comprehensive mapping of the existing technical capacity, resources, and sources of raw materials available on the continent. Meanwhile, governments should work to forecast demand for locally produced products and create a favorable policy environment for local manufacturers to compete with producers from abroad, allowing them to better manage the risk associated with capital investments for scale up. Manufacturers and regulators must work to improve quality by applying international public quality standards to gain a competitive foothold, not only locally but in the broader global supply chain. The African Medicines Agency (AMA), a continental effort to harmonize medicines regulation, should be fully ratified and quickly scaled up to advance regulatory reliance, mutual recognition, and risk-based regulatory practices. The AMA will help support production of active ingredients in Africa, streamline market access, and reduce barriers to market entry for manufacturers. As of April 30, eleven countries had signed it and two had ratified it.    Progress can already be seen on multiple fronts. Ethiopia and South Africa have developed national strategies and manufacturing roadmaps that address common pitfalls such as sourcing active ingredients; addressing financial barriers; and improving quality in line with international standards. And these plans are starting to translate into specific gains. South Africa and Egypt are beginning to produce active ingredients locally—the first step in overcoming a major hurdle that makes it difficult for African manufacturers to compete with imported products from Asia. Ethiopia, meanwhile, is developing a pharmaceutical manufacturing industrial park to spur national and regional manufacturing activities.  National central banks, such as the Central Bank of Nigeria, are working to stimulate the sector by extending lines of credit to local manufacturers. In addition, Afrexim Bank, the UN Economic Commission for Africa (UNECA), and the African Center for Disease Control recently announced emergency interventions to rapidly respond to supply and policy gaps, including for medical products. Afrexim Bank further announced a $3 billion funding facility that includes funding to support local production of COVID-19 related health products. As part of this effort, UNECA and Afrexim Bank have compiled a list of fifty local pharmaceutical companies which have the capacity or have shown interest in supplying priority products.   COVID-19 is expected to drive countries to enact procurement incentives such as prioritizing and incentivizing the procurement of locally produced products, providing advanced market commitments, and establishing pooled procurement mechanisms such as those being developed by UNECA, the Federation of African Pharmaceutical Manufacturers Associations (FAPMA), and the WHO. Countries should also push global procurement agencies to consider similar incentives to further support the continent’s nascent pharmaceutical industry. Scaling up African pharmaceutical capacity will help provide sustainable access to quality medical products and increase health security during the COVID-19 pandemic and beyond. 

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