Coronavirus update: Pfizer-BioNTech and AstraZeneca data revealed; Senate hearing highlights medical uncertainties

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The coronavirus pandemic is poised to peak in a month as a confluence of Thanksgiving aftermath and upcoming holidays are likely to send cases and hospitalizations skyrocketing.

In the interim, at least one, if not two, vaccines are likely to be rolled out in the U.S., starting with the Pfizer (PFE) and BioNTech (BNTX) candidate this week. A vaccine advisory committee scheduled for December 10 will pre-empt a potential authorization that could come as early as Friday.

Data from the vaccine’s clinical trials were released Tuesday, reaffirming the potential to help effectively protect frontline health workers and nursing home residents that could be inoculated this month.

Notably, strong side effects like pain at the injection site, fatigue and headaches were common, but some of those are also present with the annual flu vaccine, experts say.

The U.S. purchased an initial 100 million doses, with the option to purchase 500 million more, according to an agreement between the government and Pfizer earlier this year.

However, a recent report highlighted that additional doses could be hard to come by as the length of time to ramp up production of raw materials is going slower than initially expected, which means the U.S. might not get additional doses until next June.

During the summer, Pfizer reportedly asked the U.S. government several times about additional doses, but was turned down. At the time, it was unknown which vaccine was going to come out ahead in the race with the strongest efficacy and best safety data.

Meanwhile, in the U.K., the first shots of Pfizer’s vaccine were administered Tuesday, after the regulatory body had approved the vaccine last week.

Paula McMahon prepares a shot of the Pfizer-BioNTech COVID-19 vaccine, as the mass public vaccination program gets underway, at the NHS Louisa Jordan Hospital in Glasgow, Scotland, Tuesday Dec. 8, 2020. The United Kingdom is beginning its vaccination campaign to inoculate people against the COVID-19 virus. (Jeff J Mitchell/Pool via AP)
Paula McMahon prepares a shot of the Pfizer-BioNTech COVID-19 vaccine, as the mass public vaccination program gets underway, at the NHS Louisa Jordan Hospital in Glasgow, Scotland, Tuesday Dec. 8, 2020. The United Kingdom is beginning its vaccination campaign to inoculate people against the COVID-19 virus. (Jeff J Mitchell/Pool via AP)

AstraZeneca details published

Details about AstraZeneca (AZN) and Oxford’s vaccine candidate were published Tuesday in The Lancet, confirming the vaccine’s efficacy but also creating more wariness about the lower-dose regimen that resulted in higher efficacy.

The trial hit a speed bump when it was paused due to a severe adverse event in the U.K. arm, but global trials were not immediately restarted. Interim results revealed last month showed the vaccine was in aggregate 70% effective, with the average coming from a difference in dosing. Two full doses provided 62% efficacy, while an initial half dose resulted in 90% efficacy.

The higher efficacy with lower-dosed trial participants, which was either an accident or on purpose, has forced the company to look at a second trial to determine the accuracy of the initial results.

It is unclear which dosing will be used for the company’s emergency use filing.

Confusing times for treatments

Even as the vaccine enthusiasm surges, treatments for COVID-19 are still languishing. To-date, no major breakthrough has been found, despite many promising options.

Hydroxychloroquine, an affordable generic, has been repeatedly found to be ineffective based on several randomized trials. A Senate hearing Tuesday to re-assert its potential as a treatment is frustrating health officials.

Top experts like Brown University’s Dr. Ashish Jha, Yale University’s Dr. Howard Forman and Gregg Gonsalves, Harvard University’s Michael Mina, Scripps Research Translational Institute Founder Eric Topol, Baylor College’s Dr. Peter Hotez and Indian University’s Aaron Carroll are among those who contributed to a post on the topic.

“The latest attempts to promote hydroxychloroquine as a COVID-19 treatment are proof of the danger in ignoring evidence and dismissing science. After months of testing beginning in the early days of the pandemic, no evidence has emerged that the drug improves outcomes in infected persons or those at risk for infection and some studies have found it causes more harm than good,” the authors wrote.

As for other treatments, the data isn’t so clear cut, according to Dr. Kevin Tracey.

Tracey, president of The Feinstein Institutes for Medical Research at Northwell Health, told Yahoo Finance it’s both a confusing and competitive landscape right now since most drugs have only been given an emergency use authorization (EUA).

“What is the path forward? Are we going to add six more EUAs and have 13 to pick from? How do you construct a path forward to get on sound science footing?” he said.

“I am not being Pollyanna about it. I lived through it,” he said of understanding the unprecedented demand for treatments as patients continue to suffer.

But, he said, regulatory and/or a collection of research bodies need to address this sooner rather than later.

“We are on the frontline of a war, with incomplete information about the enemy. We are throwing all the weapons we can. It was justifiable until now. It’s time to start a conversation about what are longer-term treatment options,” Tracey said.

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