BY ALLISON MEAKEM, AUGUSTA SARAIVA
The United Kingdom on Wednesday became the first Western country to approve a coronavirus vaccine, a decision the European Union condemned as “hasty” and potentially unsafe. Though Britain is no longer part of the EU, it is still privy to EU regulations until the end of the month; under normal circumstances, London would have to wait for Brussels’ approval before distributing a drug. But the pandemic has activated rules that allow EU member states to act unilaterally if necessary, a distinction lost on hardcore Brexiteers.
The news out of Britain—which plans to start vaccinating nursing home residents and frontline workers with Pfizer’s drug as soon as next week—has upped the pressure on countries around the world, each burdened with different regulatory regimes and different distribution plans. That threatens to make the global vaccine rollout disjointed, and potentially unequal.
Here’s where things stand with the major players.
United Kingdom
British Prime Minister Boris Johnson lauded his country’s Medicines and Healthcare products Regulatory Agency for its fast-track approval of Pfizer’s coronavirus vaccine as “fantastic,” expressing hope that the drug will “allow us to reclaim our lives.”
But the reality may not be as rosy as the prime minister’s tweets. For one, the product is far from a silver bullet: Two shots must be administered three weeks apart, meaning that the process of becoming immunized is a lengthy one. Official government guidance on the vaccine also lists a slew of possible side effects, including fever, joint pain, and nausea. The document cautions immunocompromised Britons—those most vulnerable to the coronavirus—to consult with a doctor before receiving any inoculation.
Some members of Parliament have also expressed concern about Westminster’s vaccine priority list, which makes no mention of people with disabilities and those providing unpaid care. Vaccinating immunocompromised individuals under 64 years of age also does not appear a top concern.
United States
The U.S. Food and Drug Administration will meet on Dec. 10 to discuss whether to authorize the emergency approval of the Pfizer vaccine, and a week after that to deliberate on the Moderna one. While both vaccines rely on RNA technology, the Pfizer vaccine requires ultra-cold storage, which could be an additional challenge if compared to the Moderna one, which can be stored in normal medical refrigerators.
Ahead of the meetings, U.S. airlines have reportedly started shipping vaccines into the country. If the FDA issues the green light on both vaccines, the country is planning to immunize at least 20 million at-risk people by the end of the year.
“You go from people who are either at a highest risk or are important to society,” Anthony Fauci, the director of the National Institute of Allergies and Infectious Diseases, said. “And then as you go down the list, it gets to people who are less at risk for serious disease and then, ultimately … the 25-, 30-year-old person with no underlying conditions who’s otherwise healthy.”
Despite the push to approve the vaccines, 42 percent of Americans indicate that they would not get a vaccine when it becomes available, so the United States still faces challenges to control the virus. “In order to get the country approaching normal, you never want to abandon public health measures,” Fauci said this week, adding that a return to something “approaching normal” next summer would require at least 75 percent of the population to get the shots. President-elect Joe Biden has announced that Fauci will retain his job as the nation’s top infectious disease expert under the next administration.
For these vaccine skeptics—perhaps swayed by the polarized political environment in the United States—there is potentially reassuring news. Former Presidents Barack Obama, George W. Bush, and Bill Clinton have volunteered to be inoculated on-camera to promote greater public confidence in a vaccine.
European Union
Well before news of Pfizer’s effective coronavirus vaccine broke, the European Union agreed to distribute any inoculation fairly among its member states. And though Pfizer’s vaccine was developed at home—by BioNTech, a German biotech company—the EU’s strict regulatory regime may mean its rollout could lag behind that of the United States and Britain.
Tempering initial optimism, German Health Minister Jens Spahn announced on Dec. 1: “We have to assume that approval will only happen around the turn of the year.” EU Commission President Ursula von der Leyen urged Europeans to stay “vigilant” in the interim, during which renewed lockdowns are being implemented across the bloc to stem second and third waves of infections.
While Pfizer’s vaccine would almost certainly be the first available to the European public—Germany alone has pumped $450 million into BioNTech’s development efforts—the European Medicines Agency has indicated it could issue a decision on Moderna’s shot as soon as Jan. 12. The EU has also invested heavily in AstraZeneca’s drug.
Middle East
Germany has come under fire from some activists for its decision to classify Israel as a European country in the EU’s vaccine distribution plans. Israelis would receive inoculations from the EU’s planned stockpile from AstraZeneca whenever they become approved and available in the EU. But it doesn’t appear that the EU-German plan would include vaccinations for Palestinians in the occupied West Bank and Gaza Strip, threatening to worsen disparities between Israelis and Palestinians, whose access to medical provisions and care has already been severely restricted.
Many Arab states have pre-ordered vaccines from a variety of Western drugmakers, but limited supplies pose a problem when the developed world has bought up most of the first production run. Egypt—the most populous Arab state—and Lebanon—which has been roiled by a year of economic and political tumult—have only ordered enough shots to vaccinate 27 and 15 percent of their respective populations.
Other countries in the region are looking east, not west, for reprieve. Bahrain and the United Arab Emirates have partnered with Sinopharm CNBG, which developed China’s experimental vaccine. The UAE in September became the first country outside of China to approve the drug. In October, the Gulf state announced it was also conducting phase three trials of the Russian vaccine Sputnik V.
Iran is reportedly developing its own coronavirus vaccine, with eight candidates set to begin phase one trials before the end of the Persian calendar. It is expected to reach the Iranian public by summer.
East Asia
China, ground zero for the coronavirus, sees vaccine development as an opportunity to repair the international standing it has lost over the course of the pandemic. The country has five vaccine candidates operating phase three clinical trials, three of which have been approved for emergency usage. Officials at one of the pharmaceutical companies involved in the effort, Sinopharm CNBG, claim that there has not been a single case of infection amongst those inoculated during clinical trials in June.
Though data backing up this proclaimed efficacy is not fully transparent, international observers are intrigued by the fact that COVID-19 itself has been virtually eradicated in China itself. As a result, drugmakers have had to go elsewhere to conduct clinical trials; at present, Chinese vaccines are being tested in at least 16 countries.
China hopes to distribute its vaccine in the developing world in particular. Beijing’s approach—dubbed the “Health Silk Road”—contrasts sharply with Washington’s “America first” mantra. Countries on China’s priority list include Cambodia, Myanmar, Laos, Thailand, Vietnam, Malaysia, and Afghanistan. There are rumors that North Korean leader Kim Jong Un has already received a Chinese coronavirus vaccine.
Still, many East Asian countries are not in as much of a rush to inoculate their populations as their Western counterparts. This is largely because East Asian countries have been far more successful at stemming the virus domestically. The Korea Disease Control and Prevention Agency is putting its faith in the WHO’s COVAX initiative—preferring to first observe how the various coronavirus vaccines fare elsewhere—and says it does not expect to start vaccinations until the second quarter of 2021.
Russia
Unlike China, Russia’s domestic vaccine efforts have not been complemented by a stark reduction in domestic cases. Russia’s Kremlin-sponsored Sputnik V drug was registered by the Russian Health Ministry in August and, after being bested by the U.K.’s announcement yesterday, Russian President Vladimir Putin issued a swift order calling for mass vaccinations of Sputnik V to begin immediately in his own country—which is wrestling with the world’s fourth-largest coronavirus caseload. The release had initially been scheduled for 2021.
The reported efficacy of Sputnik V is dubious. The Russian government has reported varying levels of efficacy following announcements by rival Western drugmakers—the adjusted Russian percentages are always a tad higher. In November, the Russian Duma became the locus of a coronavirus superspreader event, despite that fact that most high-level government officials had already gotten shots of Sputnik V.
Now, Putin promises his country will have two million doses of Sputnik V available to begin vaccinations by the end of the week. Inoculation will be free and voluntary, and public opinion polling indicates that only 22 percent of Russians are comfortable getting a Russian-made coronavirus vaccine.
India
India makes 60 percent of the world’s vaccines, but inoculation against the coronavirus still promises to be a tall order for this country of over 1.3 billion people. Of 30 potential vaccine candidates developed in India, five are currently undergoing clinical trials, and officials hope to vaccinate about a fifth of the population—250 million people—by July 2021.
It could be a while until India gets access to a vaccine, though. Neither Pfizer nor Moderna have begun the process of conducting clinical trials domestically—a prerequisite to approval by Indian regulators. AstraZeneca may be the country’s best hope: Not only has it undergone trials in India, it is also less expensive and more suitable to the South Asian climate than its counterparts, which must be stored and transported at extremely low temperatures.
Latin America
The region that since June has been the epicenter of the coronavirus pandemic might have to wait longer to immunize its population. With nearly 175,000 COVID-19 deaths, Brazil is working against the clock to have access to a vaccine. Brazil, which had once developed a world-renowned national immunization program, has been criticized for its response to the pandemic, mostly due to President Jair Bolsonaro’s denial of the seriousness of the virus.
This week, however, the Brazilian Health Ministry indicated that it will start its vaccination campaign in the first quarter of 2021, and it plans to immunize around 110 million at-risk people then. Health care workers, those older than 75, and Indigenous people will be among the first ones to receive the vaccine.
“Starting today, Brazil starts thinking in a more concrete way about the COVID-19 vaccination,” the country’s secretary for health vigilance said.
Mexico has indicated that it plans to start its mass vaccination campaign in December, and that it hopes to immunize around 90 percent of its population next year. Meanwhile, countries like Colombia and Argentina are likely to wait until the first half of next year to have access to the vaccines, but are hoping to immunize between 30 and 40 percent of their populations by then.
The region’s economic plight also has governments worried about the costs of immunization, so many are hoping to produce the vaccines themselves. In August, Mexico and Argentina announced a partnership with AstraZeneca to produce up to 250 million doses to be sold in Latin America for less than $5 each. A week before that, the British company had already closed a deal with the Brazilian government to locally produce at least 100 million doses of the vaccine.
Africa
After being one of the last regions to be hit by the coronavirus, Africa may also become the last one to begin a mass immunization campaign. The ultra-cold temperatures required for the storage of some of the promising vaccines are still a huge challenge across much of Africa. And similarly to Latin America, the high costs associated with the implementation of immunization campaigns pose a challenge for governments across the continent.
“It will not be, in my view, up until the middle of next year before we start truly getting vaccinations into Africa,” John Nkengasong, the director of the Africa Centres for Disease Control and Prevention, said.
Through COVAX, a global initiative to provide governments with equitable access to the COVID-19 vaccine, the World Health Organization estimates that at least 3 percent of Africa’s population will have access to it starting this year, a number that is likely to scale up to 20 percent by the end of the first quarter of 2021.
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