NEW DELHI: India’s drug regulator on Friday approved a coronavirus vaccine developed by AstraZeneca and Oxford University for emergency use, two sources with knowledge of the matter told Reuters.
The decision clears the vaccine’s rollout in the world’s second-most populous country which, after the United States, has the highest number of COVID-19 infections.
India wants to start administering the vaccine soon, most likely by Wednesday, said one of the sources, both of whom declined to be named ahead of an official announcement expected later in the day.
A representative of India’s Central Drugs Standard Control Organization (CDSCO), whose experts are meeting for the second time this week, declined to comment.
Britain and Argentina have already authorized the AstraZeneca vaccine for urgent public use.
The CDSCO is also considering emergency-use authorization applications for vaccines made by Pfizer Inc. with Germany’s BioNTech, and by India’s Bharat Biotech.
Cheaper and easier to distribute than rival shots, the AstraZeneca/Oxford vaccine could be a game-changer for global immunization.
Countries with relatively basic health infrastructure have high hopes for a shot that, unlike Pfizer’s, can be stored and transported under normal refrigeration, rather than supercooled to -70 degrees Celsius (-94 Fahrenheit).
India has reported more than 10 million COVID-19 cases, though its rate of infection has come down significantly from a mid-September peak. The country hopes to inoculate 300 million of its 1.35 billion people in the first six to eight months of 2021.
Britain became the first country this week to authorize the AstraZeneca vaccine, moving ahead of other western countries as it seeks to stem a record surge of infections driven by a highly contagious form of the virus that has also surfaced in India.
The AstraZeneca shot is being manufactured in India by Serum Institute of India (SII), the world’s biggest producer of vaccines, which has already stockpiled about 50 million doses.
Though the Indian government has not yet signed a purchase agreement with SII, the company says it will focus on the home market first, and then exports — mainly to South Asian countries and Africa.
Questions about the degree of effectiveness of the AstraZeneca shot have surrounded it since data published in November showed a divergence in success rates, which the developers said reflected different dosing regimens.
Britain’s medicines regulator further clouded the picture this week when it said that it had found an 80% success rate when two full doses were administered, three months apart, higher than the average that the developers themselves had found.
India drug regulator approves AstraZeneca COVID-19 vaccine, country’s first
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India drug regulator approves AstraZeneca COVID-19 vaccine, country’s first
- Britain and Argentina have already authorized the AstraZeneca vaccine for urgent public use
- Countries with relatively basic health infrastructure have high hopes for a shot that, unlike Pfizer’s, can be stored and transported under normal refrigeration
Trump’s new tariffs shift focus to balance of payments; economists see no crisis
President Donald Trump’s temporary 15 percent tariffs to replace those struck down by the US Supreme Court are meant to resolve a problem that many economists say does not exist: a US balance of payments crisis, making them potentially vulnerable to new legal challenges.
Hours after the high court on Friday struck down a huge swath of tariffs Trump had imposed under the International Emergency Economic Powers Act, the president announced the new duties under Section 122 of the Trade Act of 1974 — a never-used statute that even his own legal team dismissed as irrelevant months ago.
Collections of the new 15 percent tariffs began at midnight on Tuesday as IEEPA tariff collections of 10 percent to 50 percent halted.
The Section 122 law allows the president to impose duties of up to 15 percent for up to 150 days on any and all countries to address “large and serious” balance-of-payments deficits and “fundamental international payments problems.”
Trump’s tariff order argued that a serious balance of payments deficit existed in the form of a $1.2 trillion annual US goods trade deficit and a current account deficit of 4 percent of GDP and a reversal of the US primary income surplus.
Some economists, including former International Monetary Fund First Deputy Managing Director Gita Gopinath, disagreed with the Trump administration’s alarm.
“We can all agree that the US is not facing a balance of payment crisis, which is when countries experience an exorbitant increase in international borrowing costs and lose access to financial markets,” Gopinath told Reuters.
Gopinath rejected the White House’s claim that a negative balance on the US primary income for the first time since 1960 was evidence of a large and serious balance of payment problem.
She attributed the negative balance to a large increase in foreign purchases of US equities and risky assets over the past decade, which outperformed foreign equities over this period.
Mark Sobel, a former US Treasury and IMF official, said that balance of payments crises are more associated with countries that have fixed exchange rates, and noted that the floating-rate dollar has been steady, the 10-year Treasury yield fairly stable, with US stocks performing well.
Josh Lipsky, chair of international economics at the Atlantic Council think tank, agreed, noting that a balance of payments crisis occurred when a country could not pay for what it was importing or was unable to service foreign debt. That was fundamentally different from a trade deficit, he added.
Brad Setser, a currency and trade expert at the Council on Foreign Relations who served as a senior adviser to the US Trade Representative in the Biden administration, took a somewhat contrarian view, arguing in lengthy X posts on Sunday that the Trump administration may have a reasonable case that there is a “large and serious” balance of payments deficit.
He noted that the current account deficit was far higher than when then-president Richard Nixon erected tariffs in 1971 to address a balance of payments crisis, and the US net international investment position is much worse. This “gives the administration a real argument,” in favor of its tariffs, Setser wrote.
The White House, US Treasury and US Trade Representative did not immediately respond to requests for comment about the use of Section 122.
WRONG STATUTE FOR THE JOB
Despite the Trump administration’s new focus on balance of payments, the Justice Department had previously argued that Section 122 was the wrong statute to handle a national emergency over the trade deficit.
In court filings in its defense of IEEPA tariffs, the Justice Department said Section 122 would not have “any obvious application here, where the concerns the president identified in declaring an emergency arise from trade deficits, which are conceptually distinct from balance-of-payments deficits.”
Neal Katyal, who argued at the Supreme Court on behalf of plaintiffs challenging the IEEPA tariffs, told CNBC that the Trump administration’s stance against the use of Section 122 for a trade deficit will make those tariffs vulnerable to litigation.
“I’m not sure it will necessarily even need to get to the Supreme Court, but if the president adheres to this plan of using a statute that his own Justice Department has said he can’t use, yeah, I think that’s a pretty easy thing to litigate,” Katyal said.
It is unclear who might take the lead in challenging the Section 122 tariffs.
Sara Albrecht, chair of the Liberty Justice Center, a nonprofit, public-interest law firm representing several small businesses that challenged the IEEPA tariffs, said the group would closely monitor any new statutes being invoked.
Albrecht did not reveal any future litigation strategy, adding: “Our immediate focus is simple: making sure the refund process begins and that checks start flowing to the American businesses that paid those unconstitutional duties.”
In its ruling, the Supreme Court did not give instructions regarding refunds, instead remanding the case to a lower trade court to determine next steps.
Hours after the high court on Friday struck down a huge swath of tariffs Trump had imposed under the International Emergency Economic Powers Act, the president announced the new duties under Section 122 of the Trade Act of 1974 — a never-used statute that even his own legal team dismissed as irrelevant months ago.
Collections of the new 15 percent tariffs began at midnight on Tuesday as IEEPA tariff collections of 10 percent to 50 percent halted.
The Section 122 law allows the president to impose duties of up to 15 percent for up to 150 days on any and all countries to address “large and serious” balance-of-payments deficits and “fundamental international payments problems.”
Trump’s tariff order argued that a serious balance of payments deficit existed in the form of a $1.2 trillion annual US goods trade deficit and a current account deficit of 4 percent of GDP and a reversal of the US primary income surplus.
Some economists, including former International Monetary Fund First Deputy Managing Director Gita Gopinath, disagreed with the Trump administration’s alarm.
“We can all agree that the US is not facing a balance of payment crisis, which is when countries experience an exorbitant increase in international borrowing costs and lose access to financial markets,” Gopinath told Reuters.
Gopinath rejected the White House’s claim that a negative balance on the US primary income for the first time since 1960 was evidence of a large and serious balance of payment problem.
She attributed the negative balance to a large increase in foreign purchases of US equities and risky assets over the past decade, which outperformed foreign equities over this period.
Mark Sobel, a former US Treasury and IMF official, said that balance of payments crises are more associated with countries that have fixed exchange rates, and noted that the floating-rate dollar has been steady, the 10-year Treasury yield fairly stable, with US stocks performing well.
Josh Lipsky, chair of international economics at the Atlantic Council think tank, agreed, noting that a balance of payments crisis occurred when a country could not pay for what it was importing or was unable to service foreign debt. That was fundamentally different from a trade deficit, he added.
Brad Setser, a currency and trade expert at the Council on Foreign Relations who served as a senior adviser to the US Trade Representative in the Biden administration, took a somewhat contrarian view, arguing in lengthy X posts on Sunday that the Trump administration may have a reasonable case that there is a “large and serious” balance of payments deficit.
He noted that the current account deficit was far higher than when then-president Richard Nixon erected tariffs in 1971 to address a balance of payments crisis, and the US net international investment position is much worse. This “gives the administration a real argument,” in favor of its tariffs, Setser wrote.
The White House, US Treasury and US Trade Representative did not immediately respond to requests for comment about the use of Section 122.
WRONG STATUTE FOR THE JOB
Despite the Trump administration’s new focus on balance of payments, the Justice Department had previously argued that Section 122 was the wrong statute to handle a national emergency over the trade deficit.
In court filings in its defense of IEEPA tariffs, the Justice Department said Section 122 would not have “any obvious application here, where the concerns the president identified in declaring an emergency arise from trade deficits, which are conceptually distinct from balance-of-payments deficits.”
Neal Katyal, who argued at the Supreme Court on behalf of plaintiffs challenging the IEEPA tariffs, told CNBC that the Trump administration’s stance against the use of Section 122 for a trade deficit will make those tariffs vulnerable to litigation.
“I’m not sure it will necessarily even need to get to the Supreme Court, but if the president adheres to this plan of using a statute that his own Justice Department has said he can’t use, yeah, I think that’s a pretty easy thing to litigate,” Katyal said.
It is unclear who might take the lead in challenging the Section 122 tariffs.
Sara Albrecht, chair of the Liberty Justice Center, a nonprofit, public-interest law firm representing several small businesses that challenged the IEEPA tariffs, said the group would closely monitor any new statutes being invoked.
Albrecht did not reveal any future litigation strategy, adding: “Our immediate focus is simple: making sure the refund process begins and that checks start flowing to the American businesses that paid those unconstitutional duties.”
In its ruling, the Supreme Court did not give instructions regarding refunds, instead remanding the case to a lower trade court to determine next steps.
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