Connect with us

Science

National Institutes of Health disses FDA on plasma as COVID treatment

Published

on

Enlarge / Francis Collins, director of the U.S. National Institutes of Health, reportedly objected to the FDA’s decision to grant an Emergency Use Authorization to plasma treatments.

Last week, the FDA announced that it was issuing an emergency use authorization for the treatment of COVID-19: the blood plasma of people who have recovered from a COVID-19 infection. But controversy quickly engulfed that announcement after it became clear that the head of the FDA had exaggerated the effectiveness of the treatment when explaining why it was being approved.

The FDA’s salesmanship of blood plasma—which is a treatment of unknown efficacy—was taken as evidence that the emergency use authorization was the product of political pressure exerted by a Trump administration anxious to have some good news to promote its reelection campaign. Additionally, health experts at the National Institute of Health (NIH) didn’t agree with the decision and had tried to block it a week ago. Now, the NIH may be striking back, releasing a document that basically says it’s looked at the evidence and is not convinced.

Not so fast

While the CDC and FDA have led some aspects of the coronavirus response, the NIH is the employer of Anthony Fauci and the largest biomedical research organization in the world. So it certainly has things to say about how to handle the pandemic, and it maintains a COVID-19 Treatment Guidelines Panel. This, as its name implies, maintains guidelines on different aspects of care for the disease. So, given that the FDA has just given an Emergency Use Authorization to a treatment, it essentially forced the NIH to respond in some way.

And the NIH’s response is both accurate and forceful. “There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19,” the document says. The document makes clear that the Panel has reached that conclusion by examining all the published data as well as a number of unpublished studies. It contrasts that with the FDA, which based its decision on a subset of the population enrolled in a single study that lacked a control arm.

Even with that carefully selected population, the Panel notes, the analysis “found no difference in 7-day survival overall.” It was only when groups were split out based on the amount of anti-SARS-CoV-2 antibodies present that a small difference emerged.

But the NIH remains unimpressed, noting that, without randomization and a control group, other factors could have accounted for this difference. And, in any case, it’s clear that the levels of useful antibodies present vary from donor to donor.

The Panel sums up the situation bluntly. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19,” it concludes, before going on to say “Convalescent plasma should not be considered standard of care for the treatment of patients with COVID-19.” In fact, the document raises the possibility that using antibodies from other sources could dampen the production of the COVID-19 patient’s own antibodies and thus limit future protections.

Is this a warning?

It’s important to emphasize that everything the NIH’s document says is accurate. There aren’t any large, well-designed studies of the efficacy of post-infection plasma as a treatment. And the small studies cited by the FDA in its emergency use authorization don’t indicate that it’s an effective therapy. So, while doctors may be authorized to use it, it certainly shouldn’t be viewed as the standard of care. Nevertheless, the NIH’s blunt dismissal of the evidence presented by the FDA to support its decision is striking.

Given that members of the NIH’s leadership, including its director Francis Collins, had reportedly attempted to put the FDA’s authorization on hold, it’s very tempting to speculate that this is a way of calling out the FDA for making a decision with limited scientific support. It also comes on the heels of a former NIH director, Harold Varmus, calling out the Centers for Disease Control for similar reasons. It’s not clear, however, whether these public criticisms will be enough to keep these agencies focused on scientific data as the election grows ever closer.

Continue Reading

Science

NASA delays flight of Boeing’s Starliner again, this time for parachutes

Published

on

Enlarge / Starliner touches down in December 2019 for the first time.

NASA/Aubrey Gemignani

NASA and Boeing announced Wednesday that the first crewed flight of the Starliner spacecraft will now take place no earlier than July 21. This moves the vehicle’s flight, carrying NASA astronauts Suni Williams and Butch Wilmore, from the previously announced timeframe of April.

The manager of NASA’s Commercial Crew program, Steve Stich, said the delay was attributable to the extra time needed to close out the pre-flight review process of Starliner and also due to traffic from other vehicles visiting the space station in June and the first half of July.

“When we look at all the different pieces, most of the work will be complete in April for the flight,” Stich said during a teleconference with reporters. “But there’s one area that’s extending out into the May time frame, and this really has to do with the certification products for the parachute system.”

Boeing has conducted more than 20 tests of its parachute system, including dropping the vehicle from different altitudes to test their deployment sequence and how the parachutes perform in different environments to simulate returning from space. Stich said there are no issues with the parachutes, which are installed on Starliner already. Mostly, it is about reviewing all the tests Boeing has done to ensure the parachutes performed as intended.

“It’s just a matter of going through all that data and looking at the data and making sure we’re really ready to go fly safely,” Stich said.

There is one final test to be completed on the ground, he said, of a parachute subsystem that pulls Starliner’s forward heat shield away and sets up deployment of the drogue and then main parachutes. That test is targeted for May.

The additional time needed to complete the review process of Starliner and its parachute system delayed the vehicle’s launch into June. However, at that time, NASA plans to launch SpaceX’s CRS-28 cargo resupply mission, which will tie up one of the lab’s docking hatches. This supply mission is bringing solar arrays to the station that NASA does not want to delay because it would delay planned spacewalks to install them. The lack of a docking port, therefore, pushed the Starliner flight into the second half of July.

NASA and Boeing must also balance schedules with United Launch Alliance, which is boosting the mission to orbit with its Atlas V rocket. The company presently has the USSF-51 mission scheduled for the Space Force this summer and also needs the Space Launch Complex-41 pad for the debut of its Vulcan rocket in May or later this summer.

This will be the third flight of Boeing’s Starliner spacecraft. The vehicle’s debut in December 2019 failed to rendezvous with the International Space Station after multiple issues, including software problems. After fixing these issues, Boeing flew the vehicle on a second test flight in May 2022. Although there were some propulsion issues with this flight, Starliner docked with the space station, setting the stage for a crewed flight test.

After Boeing completes this critical test flight and NASA certifies the vehicle as ready for operational missions, the company will fly approximately once a year to the space station for regular crew rotations. The first of these operational missions is planned for no earlier than the spring of 2024.

Continue Reading

Science

California wants to build more solar farms but needs more power lines

Published

on

Enlarge / Westlands Solar Park, near the town of Lemoore in the San Joaquin Valley of California, is the largest solar power plant in the United States and could become one of the largest in the world.

Carolyn Cole/Los Angeles Times via Getty

California’s San Joaquin Valley, a strip of land between the Diablo Range and the Sierra Nevada, accounts for a significant portion of the state’s crop production and agricultural revenues. But with the state facing uncertain and uneven water supply due to climate change, some local governments and clean energy advocates hope solar energy installations could provide economic reliability where agriculture falters due to possible water shortages.

In the next two decades, the Valley could accommodate the majority of the state’s estimated buildout of solar energy under a state plan forecasting transmission needs [PDF], adding enough capacity to power 10 million homes as California strives to reach 100 percent clean electricity by 2045. The influx of solar development would come at a time when the historically agriculture-rich valley is coping with new restrictions on groundwater pumping. Growers may need to fallow land. And some clean energy boosters see solar as an ideal alternative land use.

But a significant technological hurdle stands in the way: California needs to plan and build more long-distance power lines to carry all the electricity produced there to different parts of the state, and development can take nearly a decade. Transmission has become a significant tension point for clean energy developers across the US, as the number of project proposals balloons and lines to connect to the grid grow ever longer.

Existing lines are not enough to accommodate the spike in large clean energy installations, planning new transmission has lagged, and regulators have struggled to keep up with studying and processing all the projects looking to hook up to the grid.

“It’s undeniable that we do need major funding for transmission buildout in California, and frankly, the West, to meet our clean energy goals,” said Dian Grueneich, a former commissioner on the California public utility commission. “The issue is where, how much, when, et cetera, … It’s probably the most complex area there is.”

Compared to other regions, California has been relatively proactive in assessing the grid needs of a decarbonized future, said Rob Gramlich, founder of consulting firm Grid Strategies LLC. But there’s still much work to do.

“It’s a systemic problem across the country. We have interconnection queue process problems in most regions,” said Gramlich. “The problem is more acutely felt in any region that is going faster on the energy transition. And California is second to no one on the pace and ambition of its clean energy transition.”

That challenge could cause particular difficulties in regions of California expecting a big scale-up in renewable energy, like the North Coast, where offshore wind developers are planning projects, or areas of the Central Valley eyed by solar companies and facing a potential downturn in the water available for crops.

“Short of water”

In coming years, more land in California once used for agriculture could host solar. In 2014, the state approved the Sustainable Groundwater Management Act, an effort to reduce over-pumping from aquifers that had caused land in certain parts of the state to sink. The law requires local water managers to submit plans to the state that demonstrate how they’ll keep industries and people from pulling water out of underground stores more quickly than it can be replenished.

California farmers get water for their crops via a combination of underground supplies and diversions from reservoirs, lakes, and other stores managed by the state and the federal Bureau of Reclamation. The new groundwater regulations, combined with climate change and other environmental regulations, could lead to a 20 percent drop in annual average water supplies in the San Joaquin Valley by 2040, according to a February analysis from the Public Policy Institute of California (PPIC).

Continue Reading

Science

Healthy adults don’t need annual COVID boosters, WHO advisors say

Published

on

Enlarge / A vial containing Moderna COVID-19 booster vaccine at a vaccination center.

A vaccine advisory group for the World Health Organization said Tuesday that, at this point, it does not recommend additional, let alone annual COVID-19 booster shots for people at low to medium risk of severe disease. It advised countries to focus on boosting those at high risk—including older people, pregnant people, and those with underlying medical conditions—every six to 12 months for the near- to mid-term.

The new advice contrasts with proposed plans by US Food and Drug Administration, which has suggested treating COVID-19 boosters like annual flu shots for the foreseeable future. That is, agency officials have floated the idea of offering updated formulations each fall, possibly to everyone, including the young and healthy.

In a viewpoint published last May in JAMA, the FDA’s top vaccine regulator, Peter Marks, along with FDA Commissioner Robert Califf and Principal Deputy Commissioner Janet Woodcock, argued that annual COVID booster campaigns in the fall, ahead of winter waves of respiratory infections—such as flu, COVID-19, and RSV—would protect health care systems from becoming overwhelmed. And they specifically addressed the possibility of vaccinating those at low risk.

“The benefit of giving additional COVID-19 booster vaccines to otherwise healthy individuals 18 to 50 years of age who have already received primary vaccination and a first booster dose is not likely to have as marked an effect on hospitalization or death as in the other populations at higher risk,” the FDA officials wrote. “However, booster vaccinations could be associated with a reduction in health care utilization (e.g., emergency department or urgent care center visits).”

In a press briefing Tuesday, WHO advisors called the benefit of boosting those at low or even medium risk “actually quite marginal” and suggested that countries could roll back offering primary COVID-19 vaccination series to low-risk healthy children and teens based on country-specific conditions and resources.

Context and limits

These updated recommendations “reflect that much of the population is either vaccinated or previously infected with COVID-19, or both,” said Hanna Nohynek, chair of the WHO’s advisory groups, called SAGE for the Strategic Advisory Group of Experts on Immunization. But the advisor’s updated guidance “reemphasizes the importance of vaccinating those still at risk of severe disease, mostly older adults and those with underlying conditions, including with additional boosters,” she added.

Specifically, the WHO’s SAGE considered high-risk groups: older adults; younger adults with significant comorbidities, such as diabetes and heart disease; people 6 months and older with immunocompromising conditions, such as people living with HIV and transplant recipients; pregnant people; and frontline health workers.

For these high-risk groups, SAGE recommended an additional booster six to 12 months after their last, given the current epidemiological conditions. The advisors noted that the advice is “time-limited” for the current situation, not one for annual or biannual shots to be offered in perpetuity. The scenario and overall recommendations could change depending on new, more virulent variants or future declines in COVID-19 spread, for instance.

Already, the United Kingdom and Canada have offered spring COVID-19 boosters to high-risk groups, including older people and those who have immunocompromising conditions. So far, the FDA has not indicated that it will do the same.

Continue Reading

Trending