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The global vaccine arrives – and questions follow - Politico

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This week we're looking at the questions surrounding the AstraZeneca vaccine before its global rollout.

THE BIG IDEA

WORLD STANDS BY ITS FAVORITE VACCINE — The coronavirus vaccine the world bet on has faced its setbacks, but it’s about to have its grand debut on the global stage. The World Health Organization’s emergency authorization of the AstraZeneca/Oxford vaccine this week set in motion its rollout across the world through COVAX, the global vaccine equity effort.

Questions linger about the shot’s effectiveness, and some countries are limiting its use. But demand is high. Some 2.3 billion doses of AstraZeneca’s two-shot regimen were pre-purchased. At least 50 countries had cleared it for use before WHO’s decision.

The vaccine was a no-brainer for developing nations – it’s easier to ship and store in a regular fridge than the mRNA vaccines, it’s cheap, and it was developed by a world-class university.

If all goes according to plan, over 200 million doses should head to countries starting later this month. For many nations, it will be the first vaccine they get, months after richer countries have started their immunization campaigns.

But hanging over the rollout is one big question: Does the vaccine prevent severe disease and death caused by the virus variant first identified in South Africa? A small study there on young people showed that it did not work as well against mild and moderate Covid-19 caused by that variant, known as B.1.351, though WHO said there is reason to believe the vaccine does prevent severe disease.

WHO and others are stressing that the vaccine should be used in all adults, including in countries that have detected virus variants such as the B.1.351. But WHO did add that countries need to make decisions based on their local situation. The problem is that many countries don’t have the genetic sequencing capacity to determine which variants are circulating within their borders. And it could be between six and nine months before AstraZeneca develops a booster shot better targeted against the variants, a company executive said.

The focus now should be on preventing hospitalization and deaths, and all the available vaccines are effective in doing that, said Francois Venter, an infectious disease expert at the University of the Witwatersrand in Johannesburg. He argued that the AstraZeneca vaccine should still be given to people most at risk in the country and should not be compared to other shots.

“It’s like comparing two luxury vehicles and saying, ‘Your cup holder is bigger than my cup holder,’” he said.

There are other reasons to be optimistic. Oxford University said its vaccine is effective against the variant first identified in the United Kingdom and, separately, that its efficacy rate seems to increase to 82.4 percent if the two doses are spaced out more. The vaccine also appears to reduce transmission of the virus, it said, though more study is needed on that.

Not everyone’s convinced: Even before the variants emerged, there were some questions about how the AstraZeneca clinical trials were designed and communicated to the public. Due to a dosing mistake, the vaccine appeared to work better when given as a half-dose, then a full dose a month later. The company hasn’t made clear whether it’s doing further study of that dosing strategy. Either way, WHO and other regulators have authorized the vaccine as a full two-dose regimen.

South Korea and some European countries, including Germany, Italy and France are not using the vaccine for people 65 or older because of the limited testing in that population, although that age group is especially susceptible to the virus. The European Medicines Agency and WHO have recommended otherwise.

South Africa has halted use of the vaccine as B.1.351 remains the dominant strain in the country. Instead, it’s rolling out the one-shot Johnson & Johnson vaccine just for health workers, even before any country has authorized it. A clinical trial for the J&J vaccine in South Africa showed 57 percent efficacy in the country, lower than the 72 percent in U.S. trials, mainly due to the variant. One benefit is the shot could be produced locally by Aspen Pharmacare, Africa’s largest drugmaker, based on a deal with J&J.

Meanwhile, South Africa offered to provide the African Union with the 1 million doses of AstraZeneca it got through the Serum Institute of India.

WELCOME TO GLOBAL PULSE

WELCOME BACK TO GLOBAL PULSE, where your author has been trying to convince her almost 70-year-old mother that she’s much, much likelier to die from Covid-19 than any of the vaccines. She grew concerned after news reports of a 55-year-old woman in Romania dying a week after being vaccinated, though the authorities are investigating whether there was any link.

Meanwhile, have you heard of any smart ways countries or local governments are trying to convince people that may be hesitating, like my mother? If so, send some examples my way and they could be featured in a future edition of Global Pulse.

Global Pulse is a team effort. Thanks to my editors Jason Millman and Joanne Kenen.

IN THE SPOTLIGHT

WHO’S SHARING VACCINE — It’s not the usual suspects. While the United States, Canada and the European Union are focused on vaccinating their people as soon as possible, Russia, China and India are sharing doses of vaccines developed domestically.

The effort at “vaccine diplomacy,” either through bilateral deals or donations, in some cases is providing the only doses some poor countries can get their hands on. And it’s sparking suspicion from some richer Western countries of how the shots are being used as geopolitical tools, particularly when it comes to Russia’s Sputnik V.

That vaccine has been surrounded by doubts since Russia approved it last summer before completing critical late-stage testing. However, it got a boost this month after publication of peer-reviewed Phase III data showing it to be 91.6 percent effective.

Some European officials remain skeptical, but other countries are embracing the shot. Twenty-nine of them have approved Sputnik V so far, according to the Russian Direct Investment Fund, the government-backed entity that financed the vaccine’s development. Most of them are low- and middle-income countries, including Gabon, Lebanon and Nicaragua. They may soon be joined by India.

What’s still not certain is how many doses Russia can provide to the world, and how quickly. There are differing accounts of how many doses have been pre-purchased, with Duke University tallying just over 300 million doses and Bloomberg counting 762 million. The Russian investment agency did not respond to our request to clear things up.

Hungary became the first European Union country to approve the vaccine, even before the bloc’s regulator, the European Medicines Agency, reviews it. When that will happen is in doubt, especially since EMA and the Sputnik V developers aren’t even on the same page about whether the vaccine was submitted for approval. (The EMA said it wasn’t.)

But even the suggestion from German Chancellor Angela Merkel that all vaccines cleared by EMA would be welcome in Europe lends credibility to Sputnik V, said David Fidler, an adjunct senior fellow for cybersecurity and global health at the Council on Foreign Relations

The comment, made on the day the Lancet published Sputnik V’s Phase III data, could be seen as “a political message to the developing world that, ‘Well, we better talk to the Russians,’” Fidler said.

More countries in Central and Eastern Europe have grown interested in the Russian-made vaccine. European Commission President Ursula von der Leyen appeared to offer some pushback Wednesday, questioning why Russia is offering millions of doses abroad while so many of its citizens remain unvaccinated. Almost 4 million people in Russia have received at least one dose of the vaccine, just under 3 percent of the total population, and polls show high skepticism in the country toward Sputnik V.

However, Russia’s offer may not be so unusual by WHO’s own recommendations. The U.N. health agency asked countries to share doses as soon as they have vaccinated their most-vulnerable groups, so health care workers everywhere would have access to a shot by April. Few countries appear ready to heed that call.

Chinese vaccines have also been filling some gaps. The country donated to Pakistan 500,000 doses of the vaccine developed by state-run Sinopharm, and it gave another 200,000 to Zimbabwe this month. Other countries have pre-purchased 230 million doses of Sinopharm and around 260 million doses of Sinovac’s vaccine, according to Bloomberg. The two developers have not yet published peer-reviewed data of their Phase III trials. WHO is expected to make a decision about their emergency approval in March, at the earliest.

The world’s leading democracies have little credibility right now on helping poorer countries with vaccine supplies, providing an opening for China and Russia to win favor with poor countries, Fidler said. But he said they’re unable to do that for now because they are also struggling to ramp up production capacity, the same as Western vaccine makers. Plus, they have big populations at home to vaccinate – though Vladimir Putin or Xi Jinping have less to fear about voter backlash for slow vaccine rollouts.

“But they do have these bilateral deals or donation deals to gain some political benefit from the fact that you've got these vaccines available,” Fidler said.

India, a newcomer to the vaccine diplomacy party, has also been gifting AstraZeneca doses produced by the Serum Institute to countries, including Bangladesh and Seychelles. A vaccine developed domestically by Bharat Biotech and approved in India before testing was completed has started seeking regulatory approval in other countries, such as the Philippines.

QUOTE OF THE WEEK

BEYOND THE PANDEMIC

EBOLA REARS ITS HEAD AGAIN — TWICE: The resurgence of Ebola in two African countries will test health systems still struggling to tame the coronavirus.

But unlike in 2014, the world appears ready to respond quickly and aggressively, boosting the chances of containing these flare-ups so they don’t explode. Plus, we have vaccines and therapies approved in recent years to deploy.

What happened: The Democratic Republic of Congo and Guinea each reported outbreaks within a week of each other after a few cases were confirmed in each country. The two outbreaks are not related, WHO said.

There are four confirmed cases in the DRC, including two people who have died. The cases were detected in the vast northeastern region of North Kivu, which borders Uganda and Rwanda, and which had a large outbreak between 2018 and 2020.

Guinea’s outbreak is in the southern rural community of Gouéké in N’Zerekore, close to the border with Liberia and Côte d'Ivoire. The local authorities found a cluster of seven confirmed and suspected cases that started with a nurse who was misdiagnosed with typhoid and later with malaria. Five, including the nurse, have died, and two are in isolation in health facilities. The nurse and those in isolation have been confirmed as having Ebola.

Guinea was where the largest Ebola outbreak ever started in 2014, before spreading to neighboring Sierra Leone and Liberia. By the time it ended in 2016, more than 11,000 people had died.

The current outbreaks are in areas that have recent experience with the virus, which is beneficial to responding rapidly, conducting contact tracing and providing care for the sick, WHO boss Tedros Adhanom Ghebreyesus said this week. But they are also in “hard-to-reach, insecure areas with some mistrust of outsiders,” he said.

The new outbreak again threatens the countries hardest hit by the major West Africa outbreak, WHO’s emergencies response boss Mike Ryan warned. The Biden administration said it is ready to help, emphasizing its commitment to global health security.

What’s being done: Vaccines and monoclonal antibodies are being deployed in both countries with reported cases. The DRC has started vaccinating people with Merck’s Ervebo vaccine, and there are enough doses for 16,000 people. So far, about 70 people have been vaccinated. There’s also enough monoclonal antibodies available there to treat 400 patients, Ryan said.

About 20,000 vaccine doses are expected to arrive in Guinea on Sunday, Georges Ki-Zerbo, the WHO representative in Guinea, told Global Pulse. He also expects monoclonal antibodies will arrive this week. But the WHO said this morning that the type of Ebola virus has not been identified yet. If it's not Zaire ebolavirus, the only type vaccines are available for, that would complicate the answer.

Field teams are trying to trace all the contacts of the confirmed cases and alert communities of the risk since the virus spreads between close contacts, Ki-Zerbo said. As of earlier this week, 192 contacts had been identified in N’Zérékoré and the capital Conakry.

He underlined the need to get the community involved, which was one of the lessons learned from the previous outbreak there. Eight people, including health care workers, journalists and government officials, were killed in a September 2014 attack while trying to educate the population about the outbreak.

AROUND THE WORLD

U.S. MONEY FLOWING BACK TO WHO — The United States will pay over $200 million in dues owed to WHO by the end of this month, Secretary of State Antony Blinken told the U.N. Security Council on Wednesday. That money had been withheld by the Trump administration after the former president moved to withdraw the U.S. from WHO, a decision that President Joe Biden reversed.

WORRYING SIGNS IN MYANMAR — What happens when a military coup clashes with a pandemic? For now, it may be too early to tell in Myanmar, but there are some worrying early signs.

Daily testing rates have fallen from 0.29 per thousand people on Jan. 31, the day before the military seized power, to 0.07 in recent days, according to Our World in Data.

Health care workers have gone on strike to protest the coup, while the country saw the biggest protests yet against military rule this week. It appeared that the vast majority of protesters wore masks, possibly reducing the risk of transmission.

Just before the military takeover, the country was reporting under 400 cases per day, down from a peak of almost 1,500 between September and November. The number has continued to plummet in recent weeks, reaching 30 reported cases on Feb. 15. It’s unclear whether that is part of a decreasing trend seen in other parts of the world, or if the drop-off in testing and other potential reporting gaps are obscuring the level of virus transmission there.

Two international groups working in Myanmar contacted by Global Pulse didn’t want to comment about the situation, out of fear of reprisals against their staff. Doctors Without Borders warned that arrests of health care workers and others could disrupt care and that mass detainments may lead to coronavirus outbreaks.

Aid groups are also watching for whether international funding cuts potentially make matters worse. For now, USAID said it would redirect $42.4 million that would have benefited the government to civil society. It also committed to continue working on health issues there, including by combating Covid-19.

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