This article is part of the Debatable newsletter. You can sign up here to receive it on Tuesdays and Thursdays.
The drugmakers Moderna and Pfizer buoyed hopes for an end to the coronavirus pandemic when they announced this month that their vaccines were 94.5 percent (Moderna) and 90 percent (Pfizer) effective at preventing Covid-19, based on preliminary results from ongoing clinical trials. Neither vaccine produced any serious safety concerns.
Pfizer’s and Moderna’s data were analyzed by independent experts, though their findings were published in news releases, not peer-reviewed scientific journals, so the results are not yet considered conclusive. But if the numbers hold steady through the end of the trials, these vaccines would be among some of the most effective ever created.
What would that mean for the future of the pandemic and vaccine science, and what obstacles still stand in the way of getting shots in people’s arms? Here’s what people are saying.
An unexpected breakthrough
The clinical success that Pfizer and Moderna are reporting was not supposed to happen. The average influenza vaccine, for comparison, is only about 50 percent effective. Public-health experts have warned for months that a coronavirus vaccine might be similarly mediocre, and was therefore unlikely to provide the silver bullet so many hoped for.
“The best we’ve ever done is measles, which is 97 to 98 percent effective,” Dr. Anthony S. Fauci, the nation’s top infectious disease expert, told CNN in June. “That would be wonderful if we get there. I don’t think we will.”
Five months later, Dr. Fauci’s tone has changed. “I’d said I would be satisfied with a 70, 75 percent efficacy, that something like 95 percent was really aspirational,” he said Monday. “Well, our aspirations have been met, and that is really very good news,” he added, calling Moderna’s results “truly striking.”
A potential leap forward for science
If these vaccines do manage to bring the pandemic to a close, they will also open up a new era in infectious disease prevention.
For as long as vaccines have existed, most have worked by presenting the body with a weakened virus, or part of one, which trains the immune system to combat its natural incarnation.
Pfizer’s and Moderna’s belong to a new generation of vaccines. Both contain a synthetic snippet of the coronavirus’s genetic material, called messenger RNA or mRNA, that the body uses to manufacture the so-called spike protein on the virus’s surface. That protein, in turn, sets off a response that arms the immune system’s defenses.
Although many genetic vaccines are being developed for other diseases, these would be the first ever approved for human use.
[Related: “How a once-dismissed idea became a leading technology in the Covid vaccine race”]
One of the promises of genetic vaccine technology, which has been in development for 30 years, is that viral genomes can now be sequenced and synthesized in a matter of hours and weeks. “Even after we defeat Covid-19, new viruses will come along,” Walter Isaacson writes in The Washington Post. “When that happens, it will take only days to code a new RNA sequence to make a vaccine to target the new threat.”
But several steps remain before that possibility becomes reality:
The Pfizer and Moderna data still have to be reviewed by the Food and Drug Administration, and it will also be important to determine whether the vaccines work equally well in older and younger people, experts told The Times. (Moderna’s vaccine, at least, appeared protective across age groups as well as racial and ethnic ones.)
Researchers also want to know if the vaccines prevent people from spreading the virus, which could bring a swifter end to the pandemic. But as Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York, told Nature, that information may be practically impossible to ascertain in a clinical setting.
Another crucial unknown is how long the vaccine-induced immunity will last. As my colleague Carl Zimmer writes, it’s possible that it will last years or diminish in months, requiring a booster.
On Twitter, Michael Mina, an assistant professor of epidemiology at Harvard, said he was slightly hesitant to assume that the vaccines would remain so effective at preventing disease over the long term, even if he was optimistic that some form of immunity would persist.
A logistical nightmare
Both companies said they expected to apply in the coming weeks to the F.D.A. for emergency authorization to begin vaccinating the public. If they get it, immunization for higher-risk groups — health care workers and older adults, for example — could begin in December, but widespread immunization would probably not happen until April, according to Dr. Fauci.
There are many reasons even that timeline will prove difficult:
Both vaccines require two shots, spaced 21 or 28 days apart, so the 45 million combined U.S. doses Moderna and Pfizer have said they could prepare by the end of the year would cover only 22.5 million Americans.
Another obstacle is storage: Pfizer’s vaccine has to be kept around minus 94 degrees Fahrenheit, which is about as frigid as the earth gets. Moderna may have an edge on the cold front: The company says its vaccine lasts up to six months at minus 4 degrees Fahrenheit, 30 days in an average fridge and 12 hours at room temperature.
Many local governments are warning that they do not have the capacity to carry out a universal vaccine drive. While the Trump administration has given billions of dollars to vaccine developers, it has sent only $200 million to states to distribute them, with $140 million more promised in December — billions short of what local officials say they need.
There’s also the issue of vaccine hesitancy: Only about two-thirds of Americans say they would get a vaccine if it reduced risk by 75 percent, according to a new survey from STAT and the Harris Poll. It’s possible that could be enough to achieve herd immunity, however, and that those numbers change.
“What we’re hoping,” Dr. Fauci said last week, “is that those who have vaccine hesitancy, who are skeptical about a vaccine, will see that the efficacy of this is so high that they may change their mind about wanting to get vaccinated.”
The storm before the calm
The pandemic has accelerated into its most dire phase yet in the United States, and it will not break for good news. Cases are now surging across most of the country, overwhelming hospitals and health care workers, and experts warn that an additional 100,000 to 200,000 people could die well before widespread immunization. Promising as the vaccines seem, “This is not going to dig us out of what’s ahead this next month,” Natalie Dean, a University of Florida biostatistician, told The Times.
What will? At the federal level, many argue that the case for another relief deal is now stronger than ever. If Congress paid for businesses to shut down and workers to stay home for four to six weeks, “We could really watch ourselves cruising into the vaccine availability in the first and second quarter of next year while bringing back the economy long before that,” said Michael Osterholm, an infectious disease expert and coronavirus adviser to President-elect Joe Biden.
But at the moment, prospects for a relief deal seem dim, Politico reported:
In the absence of federal leadership, governors seem loath to fill the vacuum: For the most part, they have resisted imposing the restrictions that public-health experts say are necessary to control the virus. (Several states and the District of Columbia, led mostly by Democrats, have also made a point of conducting their own vaccine reviews independently of the F.D.A., but some public-health experts say the decision is motivated more by partisan politics than science and may needlessly contribute to vaccine hesitancy.)
Unless these political conditions change, the responsibility for flattening the curve in the coming months, to the extent that it can be flattened, will fall largely on individuals. “If Americans want to get the current surge under control through this long, dark winter, they need to skip indoor gatherings, including for the holidays,” The Times editorial board writes. “They need to avoid nonessential travel. They must wear face masks in all public places. They all need to practice social distancing. They need to quarantine when they think they’ve been exposed to the virus and isolate if they get a positive test result, even if no symptoms emerge.”
All of this is unpleasant and unfair, but the alternative is much worse, Zeynep Tufekci argues in The Atlantic. “We are no longer in the open-ended, dreadful period of spring 2020, when we did not know if we’d even have a vaccine, whether any therapeutics would work, and whether we’d ever emerge from the shadow of this pandemic,” she writes. “We can see the cavalry coming, but until it’s here, we need to lock ourselves down once again.”
Do you have a point of view we missed? Email us at [email protected]. Please note your name, age and location in your response, which may be included in the next newsletter.
MORE ON THE VACCINES AND THE MONTHS AHEAD
“Covid vaccine excitement builds as Moderna reports third positive result” [Nature]
“Health care workers can’t go on like this.” [The Atlantic]
“How to Deal With People Who Ignore Covid Safety” [The New York Times]
“Black Americans are the most hesitant to get a Covid-19 vaccine” [USA Today]
“It’s Now Up to Governors to Slow the Spread” [The Wall Street Journal]
WHAT YOU’RE SAYING
Here’s what one reader had to say about the last edition: Five messages voters sent in the 2020 election.
Russ Abbott, professor of computer science at California State University, Los Angeles: “Like many, I regret the passage of Prop 22, Uber and Lyft’s escape hatch from taking responsibility for its drivers.
“But the media interpretation is wrong. Prop 22 passed because its backers spent extraordinary amounts of money while simultaneously posing as advocates for drivers. Barely a day passed that I didn’t receive a pro-Prop 22 mailer. Nearly all featured smiling drivers urging ‘Yes’ votes so that they could continue earning a living. Failure, the ads implied, would doom them to poverty and misery. …
“Besides that, there was no counter-advertising. No organization campaigned against Prop 22. If you think about it, there was no organization that passage of Prop 22 would hurt. Why would anyone — except a few scattered drivers who didn’t have the means to fight for themselves — oppose it?”
Source: Read Full Article
Home » Analysis & Comment » Opinion | The Latest Vaccine News Doesn’t Tell the Full Story
Opinion | The Latest Vaccine News Doesn’t Tell the Full Story
This article is part of the Debatable newsletter. You can sign up here to receive it on Tuesdays and Thursdays.
The drugmakers Moderna and Pfizer buoyed hopes for an end to the coronavirus pandemic when they announced this month that their vaccines were 94.5 percent (Moderna) and 90 percent (Pfizer) effective at preventing Covid-19, based on preliminary results from ongoing clinical trials. Neither vaccine produced any serious safety concerns.
Pfizer’s and Moderna’s data were analyzed by independent experts, though their findings were published in news releases, not peer-reviewed scientific journals, so the results are not yet considered conclusive. But if the numbers hold steady through the end of the trials, these vaccines would be among some of the most effective ever created.
What would that mean for the future of the pandemic and vaccine science, and what obstacles still stand in the way of getting shots in people’s arms? Here’s what people are saying.
An unexpected breakthrough
The clinical success that Pfizer and Moderna are reporting was not supposed to happen. The average influenza vaccine, for comparison, is only about 50 percent effective. Public-health experts have warned for months that a coronavirus vaccine might be similarly mediocre, and was therefore unlikely to provide the silver bullet so many hoped for.
“The best we’ve ever done is measles, which is 97 to 98 percent effective,” Dr. Anthony S. Fauci, the nation’s top infectious disease expert, told CNN in June. “That would be wonderful if we get there. I don’t think we will.”
Five months later, Dr. Fauci’s tone has changed. “I’d said I would be satisfied with a 70, 75 percent efficacy, that something like 95 percent was really aspirational,” he said Monday. “Well, our aspirations have been met, and that is really very good news,” he added, calling Moderna’s results “truly striking.”
A potential leap forward for science
If these vaccines do manage to bring the pandemic to a close, they will also open up a new era in infectious disease prevention.
For as long as vaccines have existed, most have worked by presenting the body with a weakened virus, or part of one, which trains the immune system to combat its natural incarnation.
Pfizer’s and Moderna’s belong to a new generation of vaccines. Both contain a synthetic snippet of the coronavirus’s genetic material, called messenger RNA or mRNA, that the body uses to manufacture the so-called spike protein on the virus’s surface. That protein, in turn, sets off a response that arms the immune system’s defenses.
Although many genetic vaccines are being developed for other diseases, these would be the first ever approved for human use.
[Related: “How a once-dismissed idea became a leading technology in the Covid vaccine race”]
One of the promises of genetic vaccine technology, which has been in development for 30 years, is that viral genomes can now be sequenced and synthesized in a matter of hours and weeks. “Even after we defeat Covid-19, new viruses will come along,” Walter Isaacson writes in The Washington Post. “When that happens, it will take only days to code a new RNA sequence to make a vaccine to target the new threat.”
But several steps remain before that possibility becomes reality:
The Pfizer and Moderna data still have to be reviewed by the Food and Drug Administration, and it will also be important to determine whether the vaccines work equally well in older and younger people, experts told The Times. (Moderna’s vaccine, at least, appeared protective across age groups as well as racial and ethnic ones.)
Researchers also want to know if the vaccines prevent people from spreading the virus, which could bring a swifter end to the pandemic. But as Florian Krammer, a virologist at Icahn School of Medicine at Mount Sinai in New York, told Nature, that information may be practically impossible to ascertain in a clinical setting.
Another crucial unknown is how long the vaccine-induced immunity will last. As my colleague Carl Zimmer writes, it’s possible that it will last years or diminish in months, requiring a booster.
On Twitter, Michael Mina, an assistant professor of epidemiology at Harvard, said he was slightly hesitant to assume that the vaccines would remain so effective at preventing disease over the long term, even if he was optimistic that some form of immunity would persist.
A logistical nightmare
Both companies said they expected to apply in the coming weeks to the F.D.A. for emergency authorization to begin vaccinating the public. If they get it, immunization for higher-risk groups — health care workers and older adults, for example — could begin in December, but widespread immunization would probably not happen until April, according to Dr. Fauci.
There are many reasons even that timeline will prove difficult:
Both vaccines require two shots, spaced 21 or 28 days apart, so the 45 million combined U.S. doses Moderna and Pfizer have said they could prepare by the end of the year would cover only 22.5 million Americans.
Another obstacle is storage: Pfizer’s vaccine has to be kept around minus 94 degrees Fahrenheit, which is about as frigid as the earth gets. Moderna may have an edge on the cold front: The company says its vaccine lasts up to six months at minus 4 degrees Fahrenheit, 30 days in an average fridge and 12 hours at room temperature.
Many local governments are warning that they do not have the capacity to carry out a universal vaccine drive. While the Trump administration has given billions of dollars to vaccine developers, it has sent only $200 million to states to distribute them, with $140 million more promised in December — billions short of what local officials say they need.
There’s also the issue of vaccine hesitancy: Only about two-thirds of Americans say they would get a vaccine if it reduced risk by 75 percent, according to a new survey from STAT and the Harris Poll. It’s possible that could be enough to achieve herd immunity, however, and that those numbers change.
“What we’re hoping,” Dr. Fauci said last week, “is that those who have vaccine hesitancy, who are skeptical about a vaccine, will see that the efficacy of this is so high that they may change their mind about wanting to get vaccinated.”
The storm before the calm
The pandemic has accelerated into its most dire phase yet in the United States, and it will not break for good news. Cases are now surging across most of the country, overwhelming hospitals and health care workers, and experts warn that an additional 100,000 to 200,000 people could die well before widespread immunization. Promising as the vaccines seem, “This is not going to dig us out of what’s ahead this next month,” Natalie Dean, a University of Florida biostatistician, told The Times.
What will? At the federal level, many argue that the case for another relief deal is now stronger than ever. If Congress paid for businesses to shut down and workers to stay home for four to six weeks, “We could really watch ourselves cruising into the vaccine availability in the first and second quarter of next year while bringing back the economy long before that,” said Michael Osterholm, an infectious disease expert and coronavirus adviser to President-elect Joe Biden.
But at the moment, prospects for a relief deal seem dim, Politico reported:
In the absence of federal leadership, governors seem loath to fill the vacuum: For the most part, they have resisted imposing the restrictions that public-health experts say are necessary to control the virus. (Several states and the District of Columbia, led mostly by Democrats, have also made a point of conducting their own vaccine reviews independently of the F.D.A., but some public-health experts say the decision is motivated more by partisan politics than science and may needlessly contribute to vaccine hesitancy.)
Unless these political conditions change, the responsibility for flattening the curve in the coming months, to the extent that it can be flattened, will fall largely on individuals. “If Americans want to get the current surge under control through this long, dark winter, they need to skip indoor gatherings, including for the holidays,” The Times editorial board writes. “They need to avoid nonessential travel. They must wear face masks in all public places. They all need to practice social distancing. They need to quarantine when they think they’ve been exposed to the virus and isolate if they get a positive test result, even if no symptoms emerge.”
All of this is unpleasant and unfair, but the alternative is much worse, Zeynep Tufekci argues in The Atlantic. “We are no longer in the open-ended, dreadful period of spring 2020, when we did not know if we’d even have a vaccine, whether any therapeutics would work, and whether we’d ever emerge from the shadow of this pandemic,” she writes. “We can see the cavalry coming, but until it’s here, we need to lock ourselves down once again.”
Do you have a point of view we missed? Email us at [email protected]. Please note your name, age and location in your response, which may be included in the next newsletter.
MORE ON THE VACCINES AND THE MONTHS AHEAD
“Covid vaccine excitement builds as Moderna reports third positive result” [Nature]
“Health care workers can’t go on like this.” [The Atlantic]
“How to Deal With People Who Ignore Covid Safety” [The New York Times]
“Black Americans are the most hesitant to get a Covid-19 vaccine” [USA Today]
“It’s Now Up to Governors to Slow the Spread” [The Wall Street Journal]
WHAT YOU’RE SAYING
Here’s what one reader had to say about the last edition: Five messages voters sent in the 2020 election.
Russ Abbott, professor of computer science at California State University, Los Angeles: “Like many, I regret the passage of Prop 22, Uber and Lyft’s escape hatch from taking responsibility for its drivers.
“But the media interpretation is wrong. Prop 22 passed because its backers spent extraordinary amounts of money while simultaneously posing as advocates for drivers. Barely a day passed that I didn’t receive a pro-Prop 22 mailer. Nearly all featured smiling drivers urging ‘Yes’ votes so that they could continue earning a living. Failure, the ads implied, would doom them to poverty and misery. …
“Besides that, there was no counter-advertising. No organization campaigned against Prop 22. If you think about it, there was no organization that passage of Prop 22 would hurt. Why would anyone — except a few scattered drivers who didn’t have the means to fight for themselves — oppose it?”
Source: Read Full Article