Tag Archives: COVID-19

The FDA just authorized the first pills for treating COVID-19

December 23, 2021 admin

This post has been updated.

On Wednesday morning, the FDA issued the first emergency use authorization for a COVID treatment pill. In a phase III trial, Pfizer’s Pavloxvid was 89 percent effective at stopping high-risk COVID patients from becoming severely ill.

The treatment could keep people out of the hospital during the Omicron wave, reducing strain on a crumbling healthcare system. But shortages, both of Paxlovid itself and of COVID tests, could limit its impact during crucial weeks.

Molnupiravir, a COVID pill developed by Merck and partner Ridgeback Pharmaceuticals, was also issued an emergency use authorization (EUA) on Thursday. However, its progress was recently paused over concerns about the drug’s effects on developing fetuses (since it works by forcing the SARS-CoV-2 virus to mutate) as well as worse-than-anticipated final results.

Unlike Molnupiravir, Paxlovid works by inhibiting a crucial protein on SARS-CoV-2 particles. One of the ingredients can interact with other drugs, and it isn’t recommended for people with severe kidney or liver problems, but it doesn’t carry the same poorly-understood risks.

Both Paxlovid and Molnupiravir are given as a five-day series of various pills, and must be started within five days of symptom onset. In the phase III trial, which was conducted on people with conditions that put them at high risk for severe COVID, only .8 percent of those who received Paxlovid were hospitalized or died—versus six percent of those who took a placebo. In the

Molnupiravir trial, 6.8 percent of the treated patients were hospitalized or died within a 29 day time period compared to 9.7 percent who received a placebo.

Who will get the COVID pill?

For the moment, Paxlovid will only be available by prescription to people over the age of 12 with a high risk of developing severe COVID.

Molnupiravir will be available by prescription to adults 18 and older with COVID-19 risk factors. Those qualifying existing conditions are described by the CDC, and include immunocompromising diseases, smoking, and heart disease, among others.

People who have a BMI above 25 also fit those criteria, though the connection between BMI and COVID severity is ambiguous. Still, that makes about 73 percent of American adults eligible to receive Paxlovid should they catch COVID-19.

For now, the FDA has not specified whether vaccinated individuals who meet the criteria above will be eligible, which means physicians will likely make their own calls.

How big of a deal is the COVID pill?

When Paxlovid was first developed, it was promising largely because a pill is much easier to deliver than existing COVID treatments, like monoclonal antibodies, which are given intravenously in a hospital. But Omicron has made several of those antibody treatments less effective, leaving providers with an incoming rush of cases and less certainty about how to address them.

Paxlovid and Molnupiravir can be prescribed for use at home, but the catch is that they must be taken within a few days of symptom onset. With hours-long lines for PCR testing in many Omicron hotspots and a shortage of at-home rapid tests, getting diagnosed in time for the treatments to make a difference could prove challenging.

But even if you’re eligible and manage to get a quick diagnosis, you still might not have a course of COVID pills in your future. Pfizer representatives recently told the Washington Post that the company expects to manufacture enough of the drug to treat 180,000 patients by the end of 2021. The Biden administration is expected to buy 3 million courses of Merck’s drug by the end of January.

Last January, the US peaked at about 250,000 new COVID cases per day. US health officials expect Omicron, which appears to be much more transmissible than other variants, to beat that record. Many of those cases will be mild. But with so many unknowns about the risk of long-haul symptoms, the CDC may need to develop firmer guidelines to determine who receives these treatments.

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Pfizer’s data on COVID vaccines for young kids has some important footnotes

September 20, 2021 admin

Pfizer announced today that it plans to seek an emergency use authorization to use its COVID vaccine in children between 5 and 12, based on what it describes as “robust” data from a Phase III trial.

That’s on the fast side of predictions about the timeline—in late August, Francis Collins, the director of the National Institutes of Health, told NPR that he didn’t expect approval until the end of the year—and it’s welcome news for parents in their first weeks of school.

But we still have little firsthand information about how well the vaccine worked, and what side effects may look like.

“I can’t honestly say anything besides, ‘sounds promising, but it’s a press release,’” wrote Angela Rasmussen, a virologist at the Vaccine and Infectious Disease Research Organization in Saskatchewan, on Twitter in response to inquiries.

That’s been a repeated theme of the pandemic, as drug manufacturers put out data-scarce press releases in advance of full information on trials. For the most part, positive findings in those press releases have been borne out. But there are reasons to stay cautious.

Critically, the pediatric trials looked at different metrics than adult trials. In adults, drug manufacturers counted the number of real-world cases in vaccinated and unvaccinated trial participants, and used those to determine efficacy numbers.

In children, the trials only looked at immune responses. According to Pfizer, children who got the smaller dose produced the same level of COVID antibodies in their blood as adults who got the full-size vaccine. But because antibody levels don’t provide a one-to-one measurement of real-world immunity, it’s possible that the FDA will have extra questions about the data provided by Pfizer.

Pediatric trials began long after the first adult trials, so it’s no surprise to have waited for children’s vaccines. But given the urgency of the pandemic and the looming school year, the delay has aggravated parents.

“Pediatric studies always take longer,” Margaret Aldrich, a pediatric infectious disease specialist at Children’s Hospital at Montefiore in New York, told HuffPost in August. Not only do the experimenters have to work around school and work schedules, but children simply need a smaller dose of the vaccine to produce similar effects.

To figure out the right amount for children, the company started with tiny doses, and then ratcheted up larger and larger until they were seeing similar immune responses in children to what they saw in adults.

They’re looking for the balancing act between a strong immune response and manageable side effects. In very young children, side effects like a daylong fever might be more dangerous than for an adult, while in slightly older ones, it might just be a small burden.

Still, demand for a children’s vaccine is bubbling, to the point that ethicists have begun weighing in on whether it’s okay to lie to get an 11-year-old vaccinated. Especially since the shot could play a key role in containing the delta variant this winter.

Early forms of SARS-CoV-2 didn’t appear to spread easily between children, and public health officials expressed some confidence that schools could be safe as long as there was enforced masking, distancing, and contact tracing procedures. But that math has been upended by the delta variant—it’s so much more infectious that children are now implicated in outbreaks.

According to the Washington Post, a CDC official presented unpublished data to an FDA expert panel in June that showed that kids might be bigger COVID spreaders than acknowledged, even “play[ing] a role similar to adults in transmission and infection.”

So far, it doesn’t appear that kids experience worse symptoms from delta. But because the new variant has burned through communities so quickly, hospitalizations among children have exploded, and by the end of August had exceeded peaks set in the winter surge.

Pfizer says that it plans to submit the data to the FDA and parallel agencies worldwide “as soon as possible.” From there, the FDA will need to deliberate over the details and issue a recommendation just as they did for those age 16 and older.

In the past, it’s taken about a month to go from a first announcement to emergency authorization. Pfizer announced positive Phase III trial results in adults on November 9, 2020 via a press release, and submitted data to the FDA on November 20th. The FDA then gave emergency use authorization for adults on December 11, 2020.

Moderna’s study on children has been underway since this summer, but hasn’t released an update on when data will be available. In July, Bloomberg reported that it expected data this fall or winter.

But in June, some members of an outside panel that advises the FDA argued that the agency should more closely scrutinize children’s vaccines. That was partly because kids are at lower immediate risk from COVID, which makes the equation different from that for adults, and partly because adolescent males are most susceptible to a rare side-effect, heart inflammation called myocarditis.

The press release from Pfizer didn’t mention heart inflammation rates specifically, saying only that side effects were “generally comparable” to those in people ages 16 to 25.

Whether that balancing act still holds in the face of delta should become clear in the next few weeks.

Vaccine Mandates Being Considered By Auto Industry, UAW

September 10, 2021 admin

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Michael Vi/Shutterstock

With the Biden administration having announced that it would start requiring companies to vaccinate employees, automakers and UAW are finding themselves in a sticky situation. Unions had previously said they wanted to hold off on endorsing or opposing mandatory vaccinations until after they discussed things with the industry and their own members. Considering Joe Biden said he wouldn’t make vaccines mandatory less than 10 months ago, employers are getting caught with their pants around the proverbial ankles.

Automakers had previously been surveying white-collar workers to see what they wanted to do while upping on-site COVID restrictions, but operating under the impression that any hard decisions were likely a long way off and left entirely to their discretion. Now the Department of Labor’s Occupational Safety and Health Administration is planning a new standard that requires all employers with 100 (or more) employees to guarantee their workforce is fully vaccinated or require any unvaccinated workers to produce a negative test result on a minimum weekly basis.

Employers that fail to implement the stated requirements could face fines of nearly $14,000 per violation, according to the White House, with penalties also doubling for those who refuse to wear masks during interstate travel. Those are potentially steep fees when you’re employees number in the thousands. Union officials have said they’re considering the matter without committing to more than absolutely necessary — though the UAW officially opposed vaccine requirements in the past.

From UAW President Ray Curry:

“The UAW has and continues to strongly encourage all members and their families to be vaccinated unless there is specific health or religious concerns. We know that this is the best way to protect our members, coworkers and their families.

We are reviewing the details of yesterday’s announcements and the impact on our members and our over 700 employer contracts.

In the meantime, we continue our member commitment to practice safety in every one of our worksites by following protocols including masks, sanitizing and reporting any exposure or symptoms of the virus. At the UAW we all understand that fighting this pandemic and protecting our families is key to our survival.”

Assuming the union ultimately decides to endorse the vaccine decree, it’s likely going to be fracturing its membership. While I am hardly against vaccinations, I strongly support informed consent and speaking candidly about this has resulted in autoworkers frequently confessing they’re similarly opposed to forced vaccinations. Many have said they would immediately quit their jobs, matching a recent Washington Post poll claiming 70 percent of unvaccinated workers would simply abandon their positions if vaccine mandates are instituted. It’s my assumption that the industry will have a sudden, catastrophic staffing shortage were it to move forward with the Biden plan.

Automakers have been similarly noncommittal, with manufacturers (including Ford, GM, Stellantis, Honda, and Toyota) stating they encourage staff to get vaccinated and want to adhere to all government-issued health protocols. But they typically steer clear of addressing the Biden plan directly, possibly indicating some hesitancy. That said, it hasn’t even been a full day since the vaccine mandate was announced and their HR and legal departments are probably wringing their hands as they ponder upon what’s to be done and the fallout it might create.

Every statement automakers have been willing to make thus far can be paraphrased into “hold on … we’ve got to think about this,” followed by a paragraph about how they believe in vaccinations and want to adhere to recommendations coming from the relevant health experts. Conversely, very little has been said about the rights or preferences of their employees.

I’m not going to beat around this bush. The entire premise of these mandates seems insane to me, bordering on wicked. As an American, I always thought the whole premise of the country was predicated upon the shared belief that personal liberties and freedom of choice trump everything else. But that doesn’t seem to be what’s coming down from the top anymore. The rhetoric being used by Joe Biden is egregiously confrontational, including statements like “we’ve been patient, but our patience is wearing thin” as he made sweeping assertions about how the unvaccinated are stifling national unity and progress. He also confusingly stated that vaccinated workers need to be “protected” from the unvaccinated.

Assuming vaccines are effective, shouldn’t it be the other way round? What exactly are we shielding people from when new strains continue to manifest, can still be spread amongst the vaccinated, and the shots we currently have are targeting older COVID variants that have lost steam?

The economic and social stress this is likely to place upon the industry and country as a whole will be nothing short of monumental. Protests have been erupting across the globe all summer. Truckers have started organizing in numerous countries and have refused to deliver to areas imposing strict COVID rules, exacerbating food shortages in urban areas. In the United States, the same was true for cities that opted to defund police departments. Now they’re starting to talk about strikes focused on vaccine and mask mandates while they’re already experiencing a severe shortage of drivers. Imagine if that spills over to an automotive sector that’s already been beleaguered by the semiconductor shortage, their suppliers, and every other industry you rely on.

[Image: Michael Vi/Shutterstock]

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