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FDA authorizes first antibody-based test for COVID-19

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The Meals and Drug Administration has issued its first authorization for a COVID-19 check that appears for antibodies within the blood, somewhat than for the virus within the nostril or throat. Whereas the antibody strategy means this check could have limitations, it’s an necessary device that would assist in the response to the pandemic.

The check is produced by the biotechnology firm Cellex. Well being care suppliers have to attract blood from a affected person’s vein to run the check, and it may well solely be executed in licensed labs — not a health care provider’s workplace. It takes 15 to 20 minutes to get a consequence.

When somebody is contaminated with a virus for the primary time, their immune system begins producing antibodies particular to that virus. Checking to see if somebody has coronavirus-specific antibodies is nice proof that they’ve been contaminated. Nevertheless, the physique doesn’t begin to make these instantly, and they may not seem till somebody’s sickness has run its course. In consequence, antibody-based checks can inform docs whether or not somebody has already had COVID-19, however they’re not pretty much as good at testing if the affected person presently has it.

Nonetheless, the FDA authorization signifies that the company thinks the advantages of getting the check out there outweigh the dangers. “It’s cheap to imagine that your product could also be efficient in diagnosing COVID-19,” the company wrote within the letter, which approved the check for emergency use.

The FDA was already permitting firms to make and distribute antibody checks for COVID-19 with out formal authorization. Nevertheless, with out approval, they weren’t in a position to declare that their check may diagnose the illness.

Even when they’re not nice diagnostics, antibody checks are critical in the response to the pandemic. They’d assist determine who has already been sick — whether or not they had important signs or not — and subsequently, who might be immune sufficient to the virus to securely transfer around the globe usually. They’ll additionally assist public well being officers perceive how a lot of the inhabitants has been contaminated by the coronavirus. Dozens of firms are working to develop antibody checks, as are researchers at the Centers for Disease Control and Prevention.

The US struggled to ramp up COVID-19 testing, and it’s nonetheless laborious for individuals to entry checks. Although there have been over 1 million checks run within the US, a milestone President Trump highlighted earlier this week, the testing charge per capita continues to be far behind different international locations. An simply out there antibody check would give individuals who weren’t in a position to get examined once they have been sick an opportunity to know if they really had COVID-19.

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SpaceX delays first historic crewed launch to space due to weather

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After getting down to just 17 minutes until launch, SpaceX had to postpone its first crewed flight to space on Wednesday afternoon due to bad weather over the launch site in Florida. Now, the two passengers on board SpaceX’s capsule — NASA astronauts Bob Behnken and Doug Hurley — will disembark the vehicle and try again on Saturday, May 30th.

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Nearly two dozen attorneys general sue Trump administration over controversial fuel standard

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The Trump administration was sued by attorneys general from 23 states and the District of Columbia over the controversial rolling back of Obama-era fuel standards. A coalition of environmental and health groups also filed suit today over the rollback. It’s the latest legal battle in President Donald Trump’s efforts to undo Obama-era plans to cut back on air pollution and greenhouse gas emissions.

In March, Trump finalized a rule that would require car manufacturers to make their new fleets 1.5 percent more fuel efficient each year, setting a goal of reaching an average of about 40 miles per gallon by 2026. That’s a much lower bar than what was set during the Obama administration, which would have pushed automakers to ramp up fuel efficiency by 5 percent each year in order to reach an average of 54 miles per gallon by 2025.

The lawsuit alleges the Environmental Protection Agency and National Highway Traffic Safety Administration used a flawed analysis to justify their rollback. The agencies did not immediately respond to a request for comment. The Trump administration has argued that the Obama-era standards would have made cars more expensive, forcing people to stick with older, less-safe models. But the attorneys general point to evidence that the weaker rules could result in an estimated thousands of premature deaths because of increased tailpipe emissions.

“What makes [Trump’s] rule so offensive is [that the Obama-era standard] is not a rule where people can say it was a disconnect. No, this was a smooth path,” Colorado Attorney General Phil Weiser said on a press call. “This was a promising path. This was a future that we need. But nonetheless, we’re seeing this happening.”

The Obama-era standards had already saved vehicle owners $86 billion at the gas pump and reduced planet-heating carbon dioxide by half a billion metric tons, according to the EPA. The new standards, on the other hand, could add up to an additional 2 billion barrels of oil and nearly an additional 1 billion metric tons of carbon dioxide. That’s about as much as 257 coal-fired power plants would put out over a year.

“Just read the text of the rule and you will discover that it is a job-killer and public health hazard,” California Attorney General Xavier Becerra said in a statement. “It will increase costs to consumers and allow the emission of dangerous pollutants that directly threaten the health of our families.” The battle over cleaner cars and air is playing out as COVID-19 strikes people with respiratory diseases especially hard, the attorneys general pointed out in today’s call.

Car companies are split over what fuel efficiency standards should be. Volkswagen, Ford, Honda, and BMW last year committed to year-over-year gains in fuel economy that exceed Trump’s weakened standards. General Motors, Toyota, and Fiat Chrysler, on the other hand, have backed Trump’s bid to revoke California’s ability to set state vehicle emissions standards higher than the federal mandate.

Ford said today that it is neither joining the suit nor defending the Trump administration’s new rule. “We have chosen a different path in support of a voluntary framework in California,” it said in a statement. “The voluntary framework gives more regulatory certainty which protects the long-term interests of the industry, affordability, consumers, and the environment.”

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Emergency COVID-19 vaccines will have to convince a skeptical public

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During the 2009 H1N1 pandemic, Sandra Quinn asked hundreds of Americans if they’d be willing to take a hypothetical vaccine that was authorized for emergency use but wasn’t formally approved by the Food and Drug Administration. Most were hesitant: Quinn, the senior associate director of the Maryland Center for Health Equity at the University of Maryland, found that only around 8 percent of people said that they’d definitely take the vaccine.

An emergency H1N1 vaccine never came to be, but the questions Quinn asked 10 years ago are back in the spotlight today, as pharmaceutical companies in the US and around the world fight to produce a coronavirus vaccine as quickly as possible. It’s a real possibility that the FDA could allow for emergency use of a vaccine this time around. The United States Department of Health and Human Services (HHS) said that it aims to have doses of the AstraZeneca vaccine candidate by October — and that “emergency use authorization or licensure of this vaccine from the U.S. Food and Drug Administration (FDA) would be required to make the vaccine available.”

Far more than 8 percent of people would probably line up for an emergency coronavirus vaccine: the virus that causes COVID-19 is a much larger threat to most people than H1N1, which didn’t trigger a societal shutdown and was far less deadly. But people’s concerns and misconceptions around experimental products haven’t gone away, and they will have to be addressed in the lead-up to any emergency use of a coronavirus vaccine.

“It’s going to be a critical point going forward,” Quinn says.

Authorization isn’t approval

If a pharmaceutical company develops a vaccine that it wants to distribute in the United States, it has to send mountains of data about it to the FDA. The agency carefully reviews that data and decides if there was clear enough evidence that it was safe and effective to approve it.

A coronavirus vaccine won’t necessarily have to go through that process. The country has been under a public health emergency since the end of January, which means that the FDA can authorize a vaccine for emergency use as soon as there’s a signal it might be effective and that its benefits outweigh the risks. It’s faster than the regular approval process, but the bar is lower: the agency just has to find that it may be effective.

The FDA has already given emergency use authorization to companies making diagnostic tests, antibody tests, and treatments for COVID-19. The same law that lets the agency sidestep the usual process during an emergency can also be used for vaccines. “The capability exists,” says Alison Bateman-House, a bioethicist and assistant professor in the department of population health at the NYU Grossman School of Medicine. “It was meant to be used for vaccines, otherwise there would have been a specific carve-out.”

The FDA would have to be more cautious with vaccines than it has been in issuing emergency authorization for drugs, though. Drugs, for the most part, are given to people who are already sick. Vaccines, on the other hand, are intended for people who are healthy. “You always have a greater burden when doing something to a healthy person versus trying to intervene on behalf of a sick person,” Bateman-House says.

The agency should have data showing that a vaccine can help prevent disease (not just that it helps people produce antibodies) and clear data on at least short-term safety, former FDA officials told the Pink Sheet. Bateman-House told The Verge that she’d be comfortable with an emergency vaccine authorization — with stipulations. “There’d have to be a really good reason you couldn’t just push through the normal way, and the evidence would have to look good,” she says.

The US is trying to speed vaccines through clinical trials as quickly as possible through Operation Warp Speed, which includes a program called Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) through the National Institutes of Health. In July, this program will test vaccine candidates on tens of thousands of people who sign up for clinical trials. The trials will look for evidence that the vaccines can blunt the spread of the virus in areas where it’s still spreading.

Experts think the October timeline proposed by HHS and AstraZeneca is unrealistic. It’ll take at minimum four or five months for researchers to have enough data to tell if people who receive the vaccine are less likely to catch COVID-19. But once that data starts to come in, if it’s promising, the FDA could go through with an emergency authorization.

Trust and consent

Creating an effective vaccine takes a herculean effort, but getting one across the finish line isn’t the only challenge. In order for a vaccine to beat back the pandemic, people have to actually agree to take it. If a vaccine is authorized by the FDA for emergency use, it’s vital that each person taking the vaccine understand exactly what it is — and isn’t. “You have to make sure someone understands that this is not an FDA approved vaccine, like the ones you’ve taken your entire life,” Bateman-House says. “Given the severity of the situation, we don’t have anything better, and we’re going to allow this product to be used.”

The challenge is, Quinn’s research shows that most people don’t have a good sense of the difference between drug approval and emergency authorization. She found that Americans have a limited understanding of FDA terminology around experimental products. “People don’t understand that kind of language,” she says. In one survey, she found people were unfamiliar with terms like “emergency use authorization,” “off-label” (which is when a drug is used for different disease than the one it was approved for), and “investigational new drug” (a drug that’s being tested in clinical trials).

Tagging a vaccine as an experimental product or something that’s being offered for emergencies only could also make people less likely to trust it. People had negative associations with terms like “experimental,” “investigational new drug,” and “emergency use authorization,” Quinn’s survey found. Half of people asked about a hypothetical, experimental H1N1 vaccine said they would be very or extremely worried about it.

People may be more willing to override their concerns about unproved or emergency use vaccines now than they said they were during the 2009 H1N1 pandemic. Those who said they were more affected by H1N1 were more likely to say they’d take an emergency vaccine, and nearly everyone in the US has been touched by COVID-19 — either by the illness directly or by the shutdowns.

“The perceived severity of the disease is going to be quite different. That could make a difference in terms of willingness to take a vaccine, but it’s an open question,” Quinn says.

Anti-vaccine sentiments, though, are stronger than they were in 2009, and there’s less trust in the government more generally. “This constant erosion over the last several years of trust and science and trust in experts, we’re seeing it on a daily basis right now. That’s a dramatic difference from 2009,” she says.

Willingness to take an emergency vaccine would also vary between racial and ethnic groups. During the 2001 anthrax attacks, for example, the Centers for Disease Control and Prevention offered postal workers who may have been exposed to the bacteria the option of taking an investigational form of the anthrax vaccine that could prevent illness. Most people didn’t take that offer — and African American workers were particularly resistant.

“It was an immediate red flag,” Quinn says. Many of the postal workers cited the 1932 Tuskegee syphilis study as the reason why they didn’t trust experimental products. During that study, the US withheld syphilis treatments from black men. Government scientists let them suffer through the course of the disease in the name of research. The erosion of trust in science from the black community has never fully recovered. Quinn’s H1N1 survey also found that black and Latino respondents were less likely to say that they’d take an emergency vaccine.

If historic distrust of scientific research leaves those communities less likely to take a vaccine if it’s offered under emergency use, vaccination gaps could contribute to the already devastating racial disparities in the impact of the COVID-19 pandemic, Quinn says. The virus is already devastating black communities: the majority of COVID-19 deaths are in disproportionately black counties.

Long-term fallout

The FDA will be under enormous pressure to authorize a vaccine as soon as possible. Without one, COVID-19 will stay a looming threat. An emergency authorization may be the best path forward, Bateman-House says, but there could be long-term consequences to public trust in vaccines. If a vaccine is tagged as something that regulators allowed to be distributed without as rigorous a review, people who are already skeptical of vaccines might take it as evidence that vaccines are risky or dangerous.

“If you hear that the government is pushing out a vaccine, and it’s not fully approved, that hits all the cognitive dissonance you already have,” she says.

If there end up being side effects from an emergency vaccine, even if they’re minor or far less severe than COVID-19 itself, that could be additional ammunition for people who are already suspicious of vaccines. The ramifications could be significant and are important to consider.

“People tend not to think of vaccines in isolation. They think of them as a group. If there’s suspicion of a COVID-19 vaccine, there will be suspicions of other vaccines,” Bateman-House says. “When you’re making this decision, you have to be aware that it could have a multi-year fallout.”

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