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As millions get vaccinated, FDA battles to make safety oversight system work

“It’s great for routine tasks, but when it comes to safety oversight, it’s all about size,” said Dr Daniel Salmon, director of the Institute for Vaccine Safety at the Johns Hopkins University and former federal vaccine official. “The bigger it is, the faster you get a response. Eventually, the VSD will get a really good answer – probably one of the best answers from anyone because they’re so good at doing it. But in a pandemic, time is not on our side.

So far, few serious problems have been reported through these channels, and no deaths have been conclusively linked to the vaccines. The 30-year initiative, known as the Vaccine Adverse Event Reporting System, or VAERS, is based on self-reported cases by patients and healthcare providers.

Health officials say so far the two vaccines already cleared for use appear to be fairly safe. There have been a few severe allergic reactions, including anaphylaxis, but they are treatable and considered rare. The rate at which anaphylaxis has occurred so far – 4.7 cases per million doses of vaccine from Pfizer and BioNTech, and 2.5 cases per million from Moderna’s vaccine – is consistent with what is happening. passes with other widely used vaccines.

Bruising and bleeding caused by low platelet count have also been reported, but it is not known whether they are vaccine-related or coincidental. A total of 9,000 adverse events were reported, of which 979 were serious and the rest classified as non-serious, according to the latest available report from the CDC.

In interviews, public health experts, including current and former FDA and CDC officials, expressed the need to improve the old “passive” surveillance, which relies on self-reporting. They said funding shortages, turf wars and bureaucratic hurdles had slowed the readiness of BEST, officially called the Biologics Assessment Safety Initiative, to monitor Covid vaccines.

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TimesVideoWatch Live: Mnuchin testifies before Congress Treasury Secretary Steven Mnuchin will testify before the Congressional Oversight Committee for the first time on his decision to end pandemic relief programs.

TimesVideoWatch Live: Mnuchin Testifies Before CongressSteven Mnuchin, Secretary of the Treasury, will testify for the first time before the Congressional Oversight Committee about his decision to end pandemic relief programs.

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Biden transition teams suggest tighter Wall Street oversight

“Private funds that relied on unimpeded access to people’s retirement accounts should start rethinking their strategy,” said Ms. Roper.

The Biden campaign does not allow members of the agency’s review teams to speak to the media, so it’s hard to know what they’re thinking and planning. But it’s clear that their ability to immediately change financial regulations could be limited by a last-minute push by Republicans to get two remaining Trump candidates on the Federal Reserve Board.

Senate Republicans made it clear on Thursday that they would try to confirm the couple, Judy Shelton and Christopher Waller, before Mr. Trump left office. If both are approved, which seems likely, Mr Trump will have occupied six of the seven seats on the Fed’s powerful board, locking in a Tory majority that could last for years and pave the way for continued surveillance. financial lighter. .

While the Fed may be best known for setting interest rates – a largely non-partisan exercise – it is also one of the most powerful financial regulators. And while monetary policy votes are shared with the Fed’s regional banks, only board members vote on the rules that govern the biggest banks.

There will be limits to what a strongly Republican Fed can accomplish on its own. Many of the most important banking restrictions – like the changes to the Volcker Rule, which prevents banks from betting with their own money – have historically been done on a cross-agency basis.

Jelena McWilliams, whom Mr Trump has named president of the Federal Deposit Insurance Corporation, has indicated she plans to complete her term, which will not end until 2023. But Mr Biden will be able to replace the interim controller of the currency soon. and should do, and other important roles, like secretary of the treasury and head of the Bureau of Consumer Financial Protection, are likely to go quickly to Democrats.

That’s why the industry is listening to members of agency review teams, which could set the tone for what’s to come.

“It will be a significant change in the direction of financial regulation if these people are to be the ones writing the policies,” said Christopher E. Campbell, 2017-18 Assistant Secretary of the Treasury for Financial Institutions. “From my point of view, the landing teams were people who seemed more militant than centrist.”

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Republicans tighten Senate suspension, but oversight could be decided in second round

Of all the victories for Senate Republicans, Ms. Collins stood out as the most notable. Facing a wave of Liberal outrage over her 2018 vote to uphold Supreme Court Justice Brett M. Kavanaugh amid sexual assault charges, she followed House Speaker Sara Gideon representatives from Maine, in the final weeks of the race.

In the end, she proved that she was one of the few senators in the country still capable of exceeding the top of the ticket significantly, winning her fifth term even as Mr. Trump lost badly in Maine to Mr. Biden. .

Yet already with the prospect of a Senate election in 2022 on more difficult terrain for Republicans, Mr McConnell suggested there were reasons the party was worried as well.

Speaking to reporters after his own dominant victory in Kentucky, he said Republicans had urgent work to do to win back the support of women and college graduates voters, as well as to strengthen their fundraising apparatus. , which has lagged behind the Democrats’ juggernaut, ActBlue.

“I am troubled by the loss of support in the suburbs of the country,” said Mr. McConnell.

Democrats remained optimistic about the races in Georgia. Rev. Dr. Raphael G. Warnock, a Democrat, was heading for a second round in January against Senator Kelly Loeffler, the Republican-nominee, in a special election to replace Senator Johnny Isakson, who retired in late 2019 due to health problems. Documentary filmmaker Jon Ossoff, 33, was in a tight race to topple Mr Perdue, who could also end up in a runoff if neither crossed the 50% threshold required by law Georgian to win.

Both sides had other goals outstanding, but they were seen as chunks. For Republicans, the best option was Michigan, where John James, a black Iraq war veteran who unsuccessfully ran for the Senate in 2018, was trying to topple Sen. Gary Peters. Democrats still believed they had an outside chance of defeating Sen. Dan Sullivan in Alaska.

Catie Edmondson contributed reporting.