Regulatory hurdles to delay vaccination in Brazil even further

. Jan 11, 2021
vaccine hit regulatory hurdles Photo: Firn/Shutterstock

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This week, we talk about the continuing hurdles preventing a vaccine from reaching Brazilians. And the question marks around the upcoming election in Congress.

Brazil’s vaccines hit regulatory hurdles

On Friday, federal health regulatory agency Anvisa received requests for the emergency approval of two coronavirus vaccines: one developed by AstraZeneca (the federal government’s main bet) and the Chinese-made CoronaVac.

Over the weekend, the agency said AstraZeneca had filed all necessary documents, while <a href="">demanding more information</a> from the São Paulo-based Butantan Biological Institute, responsible for CoronaVac trials in Brazil.</p> <ul><li>The move once again sparked concerns that Anvisa could be suffering from political interference. Brazil&#8217;s <a href="">vaccine race has become an electoral dispute</a>, with President Jair Bolsonaro and São Paulo Governor João Doria each trying to use the pandemic to boost their electoral capital.&nbsp;</li><li>On multiple occasions, Mr. Bolsonaro has bashed the Chinese-made CoronaVac, which has been developed with the support of Mr. Doria&#8217;s state government. The president claimed that his administration would neither purchase nor distribute &#8220;[Mr.] Doria&#8217;s vaccine.&#8221;</li><li>However, last week, Health Minister Eduardo Pazuello announced that the government would purchase 46 million shots of CoronaVac, with an option to buy an extra 56 million doses.</li></ul> <p><strong>Reaction.</strong> Jean Gorinchteyn, São Paulo&#8217;s top health official, said he found the new request for information by Anvisa &#8220;<a href="">odd</a>,&#8221; while Mr. Doria called for &#8220;some sense of urgency&#8221; from regulators. The governor had announced late last year his plans to start inoculating citizens on January 25.</p> <ul><li>However, São Paulo authorities have been clumsy to say the least when dealing with data around the CoronaVac clinical trials. They missed several deadlines to disclose information and have been <a href="">less than forthcoming when discussing details of broad trial results</a> presented to the public.</li></ul> <p><strong>Anti-vaccine.</strong> While elected officials butt heads over a vaccination plan, anti-vaccine movements are gaining traction in the country. A survey saw members of such groups on Facebook increasing by 18 percent. A group of researchers which has been monitoring this since 2019 has spotted three trends in Brazil&#8217;s anti-vax movement:</p> <ul><li>Those who believe vaccines are harmful;</li><li>Those who benefit financially from spreading misinformation, mentioning vaccines in order to generate interest and traffic;</li><li>The third group is fueled by political polarization. João Henrique Rafael, who leads this monitoring effort, says this segment has <a href="">grown stronger amid the pandemic</a> and has created ties with the U.S.-based QAnon, a far-right conspiracy theory-mongering movement.</li></ul> <p><strong>Losing by walkover.</strong> Anti-vaccine activists are playing unopposed, as authorities fail to provide reliable content on immunization. Mr. Rafael says the Health Ministry&#8217;s official Facebook page on vaccines has gone for three months without being updated.</p> <p><strong>Why it matters.</strong> A massive vaccination effort can only be successful with public buy-in, and trends are worrying. A recent poll shows that Brazilians unwilling to be inoculated against the coronavirus jumped from 9 to 22 percent between August and December 2020.&nbsp;</p> <hr class="wp-block-separator"/> <h2>Choosing congressional leaders in pandemic times</h2> <p>In February, Brazil&#8217;s Congress will hold <a href="">leadership elections in the Senate and House</a> — and the second coronavirus wave has cast doubt over exactly how these votes will take place. Half of senators and one-fifth of representatives are senior citizens and, therefore, part of at-risk populations.</p> <ul><li>Since March 2020, both houses have adopted a system of remote voting to allow lawmakers to work from home. But Congress rules establish that the elections for House Speaker and Senate President must be held in person — and the fact that it is a secret ballot makes remote voting processes all the more difficult.</li></ul> <p><strong>Why it matters.</strong> It is nearly impossible to hold an in-person vote within the chambers of the House and Senate without causing some form of large gathering — and a Covid-19 outbreak within Congress would obviously be highly disruptive for the country.</p> <p><strong>House.</strong> Congressman Baleia Rossi, the Speaker candidate supported by incumbent Rodrigo Maia, is in favor of remote voting. His main adversary, Arthur Lira, is opposed. Both are counting on defections from the other&#8217;s camp in order to reach a majority and are unwilling to yield to any system that seems favorable to their opponent.</p> <ul><li>If a deal is not possible, the matter could reach the Supreme Court.&nbsp;</li></ul> <p><strong>Senate.</strong> In a statement, Senate President Davi Alcolumbre said the vote will take place in person, &#8220;as the rules state, with each senator casting a paper ballot.&#8221; Some senior senators, however, are still pushing for a &#8220;semi-in-person&#8221; model, that is, with senators casting their ballots in a drive-thru scenario.</p> <ul><li>There are many worries about the possibility of defrauding the vote — and with good reason. In 2019, Mr. Alcolumbre was himself <a href="">elected to head the Senate in an election marred by scandal</a>. The first attempt at a vote was annulled after the governing board counted 82 filled ballots in a chamber of 81 Senators.</li></ul> <hr class="wp-block-separator"/> <h2>Markets</h2> <p>On Friday, two heavyweights in the healthcare industry announced discussions of a potential merger. Hapvida and Notre Dame (with a market share of 8 and 9 percent, respectively), have yet to disclose details of their plans — but recent decisions by antitrust watchdog Cade indicate that a deal of this magnitude is unlikely to be approved without restrictions. Both companies saw share prices jump over 20 percent after news of the deal broke.</p> <p><strong><em>Natália Scalzaretto</em></strong></p> <hr class="wp-block-separator"/> <h2>Slow off the mark</h2> <p>With Brazilian regulators still sifting through requests for emergency vaccine approval, the country is one of four nations badly affected by the pandemic yet to have administered a single coronavirus vaccine injection until now. The others are Colombia, Turkey, and India.</p> <div class="flourish-embed flourish-scatter" data-src="visualisation/4925206"><script src=""></script></div> <hr class="wp-block-separator"/> <h2>Looking ahead</h2> <ul><li><strong>Law enforcement. </strong>Two bills pending in Congress aim to <a href=",congresso-avalia-reduzir-poder-de-governadores-sobre-pm-e-policia-civil,70003577071">limit governors&#8217; political influence over state police forces</a>, by creating fixed terms for commandants — who are currently appointed and fired by the governor <em>du jour</em>. Supporters of the proposals say it would tame the politicization of law enforcement — while skeptics say it could turn it into a parallel power.</li><li><strong>Lockdown. </strong>Belo Horizonte, Brazil&#8217;s sixth-largest city, will enter lockdown today, with only essential businesses having permission to open. For the first time since August, Brazil&#8217;s 7-day rolling average of new daily deaths exceeded the 1,000 mark. In areas such as the Amazonian city of Manaus, the coronavirus is <a href="">spreading faster than it did early last year</a>, when local healthcare networks collapsed under the strain.</li><li><strong>Emergency aid. </strong>The February race for House Speaker has intensified debates over the potential recreation of the coronavirus emergency salary program, which expired in December. The two leading candidates say they back the proposal, which would require Congress to once again declare a state of calamity in order to lift budgetary controls. Without the aid, Brazilians would lose 3.7 percent of their revenue in 2021, per one estimate — in the North and Northeast, the two poorest regions, the hit could reach 8.5 percent.</li><li><strong>Labor market 1.</strong> According to recruiting company Cia de Talentos, <a href="">hirings of young black professionals</a> in Brazil increased 118 percent last year compared to 2019 in programs for interns, trainees, and middle managers. In big, international groups, hiring percentages exceed 40 percent. The company cites Brazil&#8217;s policy of racial quotas in federal universities — first adopted in 2004 but widespread after 2012 — as a &#8220;silent revolution&#8221; that sparked advances in equality policies.</li><li><strong>Labor market 2.</strong> The pandemic has accentuated Brazil&#8217;s <a href="">brain drain</a>, which is crippling local companies as skilled workers join foreign firms. And with the rise of remote work, companies abroad do not even need to take Brazilian workers out of the country. Without conditions to offer similar salaries, local firms often struggle to fill high-end positions.</li></ul> <hr class="wp-block-separator"/> <h2>In case you missed it</h2> <ul><li><strong>Polls. </strong>A new opinion poll by PoderData — the first since the end of the coronavirus emergency aid program — shows signs that President <a href="">Jair Bolsonaro&#8217;s approval rating could be eroding</a>. In January, the administration’s rejection rates jumped from 47 to 52 percent, outside the margin of error. The benefit <a href="">reached over 67 million people</a> and poured a reported BRL 1 trillion (nearly USD 200 billion) into the economy.&nbsp;</li><li><strong>Capitol. </strong>President Jair Bolsonaro chose to <a href="">reiterate his support for Donald Trump</a> after the outgoing U.S. head of state incited supporters to storm the Capitol building in Washington. The Brazilian leader once again voiced unproven claims of voter fraud in the U.S. election, and said Brazil could have &#8220;even worse problems&#8221; if it persists with its current electronic voting system. Political observers fear Mr. Bolsonaro could <a href="">try to stage a coup</a> should he suffer an impeachment attempt or lose re-election in 2022.&nbsp;</li><li><strong>Recovery. </strong>In its latest Global Economic Prospects report, the World Bank estimated that the Brazilian economy will bounce back 3 percent this year — <a href="">below its forecast for the global economy</a> (4%) and Latin America (3.7%). &#8220;Momentum is expected to slow as the year proceeds, in part due to the withdrawal of monetary and fiscal stimulus, bringing growth down to 2.5 percent in 2022,&#8221; says the report.</li><li><strong>Taxes.</strong> After being put under pressure by rural producers, São Paulo Governor João Doria <a href="">backpedaled on his decision to cut state tax exemptions</a> on food products and medicines. Disgruntled producers still plan on holding a tractor motorcade to protest against the state government, claiming that dairy, poultry, and fruit and vegetable farmers will continue to lose their tax benefits.</li><li><strong>Venezuela.</strong> The European Union <a href="">no longer recognizes Juan Guaidó</a> as Venezuela&#8217;s legitimate leader, after he lost his position as head of the country&#8217;s parliament. The opposition <a href="">boycotted a December parliamentary election</a> claiming that taking part would be “collaborating with the strategy of the [Nicolás Maduro] dictatorship.” The refusal to compete — a decision backed by dozens of other countries — gave Mr. Maduro a clear path to regain control of the opposition-held National Assembly in a vote that was neither free nor fair.

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