China’s coronavirus vaccines were supposed to deliver a geopolitical win that showcased the country’s scientific prowess and generosity. Instead, in some places, they have set off a backlash.Officials in Brazil and Turkey have complained that Chinese companies have been slow to ship the doses and ingredients. Disclosures about the Chinese vaccines has been slow and spotty. The few announcements that have trickled out suggest that China’s vaccines, while considered effective, cannot stop the virus as well as those developed by Pfizer and Moderna, the American drugmakers.In the Philippines, some lawmakers have criticized the government’s …
The Food and Drug Administration on Friday authorized the coronavirus vaccine made by Moderna for emergency use, allowing the shipment of millions more doses across the nation and intensifying the debate over who will be next in line to get inoculated.The move will make Moderna’s vaccine the second to reach the American public, after the one by Pfizer and BioNTech, which was authorized just one week ago.The F.D.A.’s decision sets the stage for a weekend spectacle of trucks rolling out as expert committees begin a new round of discussions weighing whether the next wave …
CVS and Walgreens have created paper and digital consent forms that nursing homes can use. Consent must be given in advance; the pharmacies need to know how many doses of the vaccine, which must be kept very cold, to bring with them.There’s significant confusion among nursing homes about getting consent, especially when it involves representatives who aren’t physically at the nursing home and can’t come because of concerns about spreading the virus. Will an email suffice? What about consent over the phone? Or will consent forms have to be signed, either in hard copy or electronically? …
After months of deliberation and debate, a panel of independent experts advising the Centers for Disease Control and Prevention is set to decide on Tuesday which Americans it will recommend to get the coronavirus vaccine first, while supply is still short.The panel, the Advisory Committee on Immunization Practices, will vote in a public meeting on Tuesday afternoon, and it is expected to advise that health care workers be first in line, along with residents of nursing homes and other long-term care facilities. If the C.D.C. director, Dr. Robert R. Redfield, approves the recommendations, they will be shared …
Nearly a year into a pandemic that has ravaged the global economy like no time since the Great Depression, the only clear pathway toward improved fortunes is containing the virus itself.With the United States suffering its most rampant transmission yet, and with major nations in Europe again under lockdown, prospects remain grim for a meaningful worldwide recovery before the middle of next year, and far longer in some economies. Substantial job growth could take longer still.A significant hope has emerged this month in the form of three vaccine candidates, easing fears that humanity could be subject to years …
The coronavirus is spreading out of control in the United States, overwhelming health systems and killing more than 1,100 Americans a day. But there is a slender silver lining: It is hastening the testing of vaccines that could eventually end the pandemic.
The surging virus has already allowed Pfizer and Moderna to accelerate the testing of their vaccines, which appear to be very effective at preventing Covid-19.
And if, as seems inevitable, the virus continues to proliferate — it is spreading faster than ever in the United States and some other countries — it is likely to speed the evaluations of promising vaccine candidates from other pharmaceutical companies.
“We are seeing something apocalyptic play out in terms of the level of transmission in the country right now,” said Dr. Peter Hotez, a vaccine scientist at the National School of Tropical Medicine at Baylor College of Medicine. “Unfortunately, this pandemic is still raging, and that affords lots of opportunities to look at vaccine efficacy.”
Over the last week, an average of more than 158,000 new coronavirus cases have been confirmed each day in the United States. More than 159,000 were reported on Tuesday.
In late-stage vaccine trials, the faster that participants get sick, the faster that drug developers gain enough data to know whether their vaccines are effective.
Researchers determine how well a vaccine works by comparing the rate at which volunteers who receive a placebo get sick versus the rate for those who receive a vaccine. If the vaccine offers strong protection, the number of people who get the placebo and then fall ill will far exceed the number of vaccinated people who get sick.
The trials are designed so that once a certain number of participants contract Covid-19, an independent panel of experts will conduct a preliminary examination of the data. (Other factors, such as how much time has passed since participants have been vaccinated, can factor into that timing, too.) The trial ends after a certain number of cases — around 150 to 170 — have accrued. That number is chosen to make sure the results have sufficient statistical power to tell how well the vaccine works.
Pfizer announced on Wednesday that its vaccine was 95 percent effective and had no serious side effects. The company, along with its German partner BioNTech, reached those findings after 170 participants in its trials — the vast majority having received a placebo — contracted Covid-19.
The news came barely a week after a preliminary analysis found Pfizer’s vaccine to be more than 90 percent effective. That data was analyzed after 94 participants caught Covid-19, nearly three times the number that the company had originally planned would set off an early look to gauge the vaccine’s efficacy.
The same phenomenon aided Moderna, which announced on Monday that an early analysis had found its vaccine to be 94.5 percent effective. The company had planned on needing only 53 cases of Covid-19 to turn up in its trial before experts would take a first look at the data. But the nationwide surge in infections helped Moderna blow past that number: The results were based on 95 sick participants.
The relatively large numbers of sick people in the trials — coupled with the vaccines’ apparent effectiveness — could help bolster public trust.
“It’s going to be hard enough to convince people to take this vaccine as it is,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink. “So the more confidence you can have, by virtue of having higher statistical power, by virtue of having more events — then that should go somewhere.”
In the coming weeks and months, the worsening pandemic could make results from other closely watched trials, such as one for a vaccine developed by Johnson & Johnson and another by AstraZeneca and the University of Oxford, available sooner and with greater statistical power.
The fast-growing pandemic could also speed up trials of treatments for Covid-19.
The drug company Regeneron, for example, is testing the antibody treatment that President Trump received after he caught Covid-19. A company spokeswoman said enrollment in its trial — participants are Covid-19 patients who have not been hospitalized — had accelerated slightly this month.
Even if the grim situation in the United States ultimately helps vaccines and treatments become available sooner, the country would have been much better off if it had kept the pandemic under control, public health experts said.
“This is not how anyone would want it to play out,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. “I’d rather be South Korea,” which has kept the virus at bay since early in the year, she said.
Vaccines are unlikely to be widely available for months. By then, tens of thousands of additional Americans will probably have perished.
Pfizer and Moderna, whose vaccines appear effective, have been waiting to see if side effects pop up in participants before the companies submit their data to the Food and Drug Administration for authorization to distribute the vaccines. Once the F.D.A. gives them the green light, manufacturers will have to ramp up production and work with governments to distribute the vaccines. Shots will initially be available only for health care workers and other vulnerable groups. When vaccines do become widely available, it is not clear if their protection will last for months, years or decades.
Hoping to fast-track their testing, drug makers have been setting up trials in Covid-19 hot spots all over the world — not just in the United States.
In China, where the virus was rampant early this year, new cases have slowed to a trickle. As a result, Chinese vaccine makers are running late-stage trials of their candidates in countries like the United Arab Emirates, Morocco, Argentina and Peru.
Novavax, based in Maryland, which is developing one of the 12 vaccines that are in the final phase of clinical testing, has enrolled more than 9,000 participants in Britain since beginning a Phase 3 trial there in September. Novavax’s president for research and development, Dr. Gregory Glenn, told analysts last week that he was “feeling very good about our ability to collect cases.”
Britain reported more than 20,000 new cases on Tuesday, part of a surge that picked up around the start of October.
Dr. Glenn added: “If you’re in the right spot at the right time, you can very quickly accumulate cases. I think we are in the right spot at the right time in the U.K.” Novavax plans to start a Phase 3 trial in the United States this month.
Vaccine developers select different parts of the world to conduct their trials for several reasons. They need to ensure that the vaccine has been tested on populations that reflect the world’s diversity. They also must make sure they can enroll participants in regions where the virus is spreading.
“What is a hot spot initially will not necessarily stay a hot spot,” said Dr. Dean of the University of Florida, who has studied how to make clinical trials flexible enough to work during epidemics.
That’s why developers testing Covid-19 vaccines have been carefully watching where the virus is surging to make decisions about where to set up sites to enroll participants.
Johnson & Johnson is testing one version of its vaccine in the United States and other countries. The trials — which are set up or planned at more than 200 locations globally, including in 30 states — were chosen in part by modeling the case numbers in different regions, said Jake Sargent, a company spokesman.
Johnson & Johnson announced on Monday that it had started another trial of its vaccine, testing two doses instead of one. The company aims to enroll 30,000 participants in Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, Britain and the United States. Johnson & Johnson said the locations were chosen “in countries and areas with high incidence of Covid-19.”
The drugmaker Moderna announced on Monday that its coronavirus vaccine was 94.5 percent effective, based on an early look at the results from its large, continuing study.
Researchers said the results were better than they had dared to imagine. But the vaccine will not be widely available for months, probably not until spring.
Moderna is the second company to report preliminary data on an apparently successful vaccine, offering hope in a surging pandemic that has infected more than 53 million people worldwide and killed more than 1.2 million. Pfizer, in collaboration with BioNTech, was the first, reporting one week ago that its vaccine was more than 90 percent effective.
The need is urgent. U.S. cases are soaring, setting new records every day. There have been more than 11 million cases and 246,000 deaths. The disease is killing more than 1,100 Americans a day, and the last million cases occurred in just six days. Some states and cities are reinstating lockdowns, restricting gatherings and closing schools once again.
Pfizer and Moderna were the first to announce early data on large studies, but 10 other companies are also conducting big Phase 3 trials in a global race to produce a vaccine, including efforts in Australia, Britain, China, India and Russia. More than 50 other candidates are in earlier stages of testing.
The Food and Drug Administration has said that coronavirus vaccines should be at least 50 percent effective to be approved.
Moderna also reported on Monday that its vaccine has a longer shelf life under refrigeration and at room temperature than previously reported, which should make it easier to store and use.
The financial markets were lifted in early trading on Monday, with shares of Moderna increasing by a little more than 6 percent, to almost $95 a share.
Researchers test vaccines by inoculating some study participants and giving others placebos, and then watching the two groups to see how many people get sick. In Moderna’s study, 95 people contracted the coronavirus: five who were vaccinated, and 90 who received placebo shots of saltwater. Statistically, the difference between the two groups was highly significant. And of the 95 cases, 11 were severe — all in the placebo group.
The 95 cases included 15 people 65 or older and 20 people who were Hispanic, Black, Asian or multiracial. The company said the vaccine appeared equally safe and effective in all the subgroups.
The results were analyzed by an independent data safety monitoring board, appointed by the National Institutes of Health.
Moderna, based in Cambridge, Mass., developed its vaccine in collaboration with researchers from the Vaccine Research Center, part of the National Institute of Allergy and Infectious Diseases.
Dr. Anthony S. Fauci, director of the institute, said in an interview: “I had been saying I would be satisfied with a 75 percent effective vaccine. Aspirationally, you would like to see 90, 95 percent, but I wasn’t expecting it. I thought we’d be good, but 94.5 percent is very impressive.”
At a news briefing on Monday, Dr. Fauci and Dr. Francis Collins, director of the National Institutes of Health, emphasized that the hopeful news did not mean people could let down their guard. On the contrary, they implored the public to “double down” on mask-wearing, distancing, hand-washing and avoiding crowds, and to stay that course until vaccine becomes available.
Stéphane Bancel, the chief executive of Moderna, said in a statement that the results had provided “the first clinical validation that our vaccine can prevent Covid-19 disease, including severe disease.”
Pfizer’s chief executive, Dr. Albert Boula, tweeted congratulations to Moderna.
Pfizer and Moderna each announced the findings in news releases, not in peer-reviewed scientific journals, and the companies have not yet disclosed the detailed data that would allow outside experts to evaluate their claims. Therefore, the results cannot be considered conclusive. The studies are continuing, and the figures on effectiveness may change.
The companies’ products open the door to an entirely new way of creating vaccines — and creating them fast. Both use a synthetic version of coronavirus genetic material, called messenger RNA or mRNA, to program a person’s cells to churn out many copies of a fragment of the virus. That fragment sets off alarms in the immune system and stimulates it to attack, should the real virus try to invade. Although a number of vaccines using this technology are in development for other infections and cancers, none have yet been approved or marketed.
“The fact that two different vaccines made by two different companies with two different kinds of structures, in a new messenger RNA concept, both worked so effectively confirms the concept once and for all that this is a viable strategy not only for Covid but for future infectious disease threats,” said Dr. Barry R. Bloom, a professor of public health at Harvard.
Natalie E. Dean, a biostatistician at the University of Florida, said an important finding was that the vaccine appeared to prevent severe disease. Pfizer did not release information about disease severity when reporting its results.
Researchers say the positive results from Pfizer and Moderna bode well for other vaccines, because all of the candidates being tested aim at the same target — the so-called spike protein on the coronavirus that it uses to invade human cells.
Dr. Bloom said that the success of the two vaccines meant that measures of immunity used in earlier phases of the studies — participants’ antibody levels — were reliable, and that other companies could use those measures as proof of effectiveness to shorten the testing and approval process for their vaccines.
It will be important to determine whether the vaccines work equally well in older and younger people, experts say. Researchers also want to know if the vaccines prevent people from spreading the virus — an ideal result that could help quash the pandemic.
Another big unknown is how long the immunity provided by the vaccines will last.
An additional concern is that both vaccines must be stored and transported at low temperatures — minus 4 degrees Fahrenheit for Moderna, and minus 94 Fahrenheit for Pfizer — which could complicate their distribution, particularly to low-income areas in hot climates. Although both vaccines are made of mRNA, their temperature requirements differ because they use different, proprietary formulations of fat to encase and protect the mRNA, Ray Jordan, a Moderna spokesman, said.
Other coronavirus vaccines being developed will need only refrigeration. If handled improperly, vaccines can become inactive.
But on Monday, Moderna said researchers had found that its vaccine had a longer shelf life in the refrigerator than previously thought: 30 days, not seven. And it will last 12 hours at room temperature, the company said.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said the relative ease of handling the Moderna vaccine would give it a big advantage.
“This vaccine presents the opportunity of using doctors’ offices, clinics and pharmacies as vaccination sites,” he said, adding that he would not be surprised, should both vaccines become available, if vaccination sites requested Moderna’s.
Both companies said they expected to apply within weeks to the F.D.A. for emergency authorization to begin vaccinating the public. In addition to the evidence for effectiveness, the companies must also submit two months of safety data on at least half of the participants.
So far, studies of the two vaccines have not found serious side effects, but participants have reported sore arms, fatigue, fever and joint and muscle aches that last for a day or two.
Moderna’s study did not include children. Dr. Tal Zaks, the company’s chief medical officer, said the company planned to test it in them in the coming months, starting with adolescents.
Moderna said it would have 20 million doses ready by the end of 2020; Pfizer said it would have about 50 million by then. Both vaccines require two shots, so 20 million doses would be enough for 10 million people.
On Friday, Moncef Slaoui, the chief scientist for Operation Warp Speed, the Trump administration’s program to accelerate development of vaccines and treatments for Covid-19, said that if any early vaccine candidates received permission for emergency use, immunization could begin sometime in December. Health experts have said the initial doses would go to high-risk people like health care workers, first responders, other front-line workers and frail people in nursing homes. Dr. Fauci said the vaccines would probably start becoming more widely available by April.
The U.S. government will buy the vaccines and give them to the public free of charge. But both companies expect to profit, and not to provide their products at cost. Moderna said it would charge other governments from $32 to $37 per dose. The charge to the United States, which has already committed about $2.5 billion to help develop Moderna’s vaccine and buy doses, comes out to about $24.80 a shot, according to Mr. Jordan, the company spokesman.
Pfizer did not take any money from the U.S. government to develop or test its vaccine. But Operation Warp Speed has promised Pfizer $1.95 billion to provide 100 million doses, which comes out to $19.50 per dose.
Both of the companies’ vaccine candidates began large human trials on the same date, July 27.
Moderna had planned a first interim analysis of its trial data when the number of Covid-19 cases among participants reached 53. But the recent surge in cases drove the number to 95, and it is likely to speed completion of the study.
The company announced on Oct. 22 that it had completed enrollment of its 30,000-person study, and that 25,650 participants had already received two shots. The company had slowed enrollment in September to ensure diversity among participants, and ultimately included 37 percent from communities of color, and 42 percent from populations considered at high risk because they were over 65 or had conditions like diabetes, obesity or heart disease.
As in Pfizer’s study, half of the participants were given the experimental vaccine and half a placebo shot of saltwater, with neither the patients nor their doctors knowing which one they had received. Moderna’s vaccine requires four weeks between shots, and Pfizer’s needs three weeks.
Dr. Zaks said Moderna’s study results were so strong that the company felt an ethical obligation to offer the vaccine to the placebo group as soon as possible.
Moderna said it could produce 500 million to one billion doses in 2021.
The company is working with the Swiss company Lonza and Laboratorios Farmacéuticos Rovi of Spain to make doses of the vaccine outside the United States.
Dr. Bloom noted that Moderna had never marketed a vaccine before, and he questioned whether the company had the capacity to manufacture hundreds of millions of doses.
Moderna has received a commitment of $955 million from the U.S. government’s Biomedical Advanced Research and Development Authority for research and development of its vaccine, and the United States has committed up to $1.525 billion to buy 100 million doses.
Moderna has already taken the early steps needed to apply to government agencies in Britain, Canada and Europe to market its vaccine, and the company has made deals to sell 50 million doses to Japan and unspecified amounts to Qatar and Israel.
Carl Zimmer and Michael de la Merced contributed reporting.
For months, scientists and public health experts have been saying the most crucial part of defusing the Covid-19 pandemic will be developing a safe and effective vaccine. So it was cause for celebration this week when Pfizer announced that an early analysis showed its vaccine candidate was more than 90 percent effective.
Now the drug maker, the government and the public health community face a new challenge: quickly making millions of doses of the vaccine and getting them to the hospitals, clinics and pharmacies where they will be injected, two separate times, into people’s arms.
If Pfizer receives authorization for its vaccine from the Food and Drug Administration in the coming weeks, as expected, the company in theory could vaccinate millions of Americans by the end of the year, taking advantage of months of planning and decades of experience.
“I am very confident. I live and breathe this,” Tanya Alcorn, a Pfizer executive overseeing the supply chain for the vaccine, said in an interview on Wednesday. “We have developed a system that does not waste any precious vaccine.”
But Pfizer — like other manufacturers that may soon be authorized to roll out their vaccines — does not fully control its own destiny. The effort will hinge on collaboration among a network of companies, federal and state agencies, and on-the-ground health workers in the midst of a pandemic that is spreading faster than ever through the United States.
Before Pfizer can begin shipping its vaccine, federal and state governments must tell it where to send how many doses. McKesson, a major medical supplier, will have to provide hospitals and other distribution sites with the syringes, needles and other supplies necessary to administer the vaccine.
Employees at those locations will need to be trained to store and administer the vaccine. They will also have to ensure that, four weeks after people get the vaccine, they return for a second dose. And millions of Americans must be persuaded to get the shots in the first place.
“We have a lot of confusion at the state and the local health departments level, and a lot of concern about the nitty-gritty of deployment,” said Dr. Saad B. Omer, the director of the Yale Institute for Global Health. “Which places, where to vaccinate, how to get the vaccine there, how to identify people in various risk groups, how to document, how to call back people for the second dose.”
Even in normal times, mass-vaccination campaigns involve many moving parts within a vast network of suppliers, transporters and middlemen.
The particulars of Pfizer’s vaccine will make this effort even more complex. The vaccine, developed with the German company BioNTech, has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before it is injected. That is about the temperature of the South Pole on a winter day and colder than any of the other leading vaccines in development.
Pending results from other front-runners in the vaccine race could change the stakes. Moderna Therapeutics said on Wednesday that it had seen enough Covid-19 cases in its late-stage study to do an early analysis of its vaccine, which uses the same “messenger RNA” technology that Pfizer’s does. The technology has never produced an approved vaccine.
Nine other candidates are also in the final stage of testing. If any of those win approval from the F.D.A., that will reduce the importance of Pfizer’s vaccine but also introduce new questions, such as which hospitals and people get the different vaccines.
For now, though, Pfizer is in the spotlight.
If an analysis planned for next week confirms the vaccine’s safety, the company is likely to ask the F.D.A. this month for emergency authorization to distribute its vaccine. In that case, limited doses will most likely be shipped to large hospitals and pharmacies to be provided to health care workers and other vulnerable groups.
But the specifics of how that will work are hazy at best.
Pfizer does not yet know where the government wants the vaccine sent or who will be first in line to receive it, said Ms. Alcorn, the supply-chain executive.
“We’re working very closely, in the U.S., in particular, with Operation Warp Speed to identify those distribution points,” Ms. Alcorn said, referring to the federal initiative to produce and distribute Covid-19 vaccines. “We don’t have them today.”
Pfizer is making the vaccine at facilities in Kalamazoo, Mich., and Puurs, Belgium. The doses distributed in the United States will mostly come from Kalamazoo.
In Kalamazoo, vaccines will go into vials (five doses per vial). Vials will go into trays (195 vials per tray). Trays will go into specially designed cooler-type boxes (up to five trays per box). Pfizer plans to have about 100,000 of the coolers by the end of this month and more than double that total by March.
The reusable boxes, each toting between 1,000 and 5,000 doses and stuffed with dry ice, are equipped with GPS-enabled sensors. Pfizer employees will be able to monitor the boxes’ locations and temperatures as FedEx and UPS transport them to hospitals and clinics nationwide.
The boxes “will have eyes on them at all times,” Ms. Alcorn said.
Representatives of UPS and FedEx said they had been planning to play a major role in distributing vaccines and were ready to go.
Once the Pfizer coolers reach their destinations, hospitals or pharmacies will have a few choices of how to store the vaccine. The easiest option is using ultracold freezers, but not many sites have them. Otherwise, the facilities can stash the trays in conventional freezers for up to five days. Or they can keep the vials in the cooler for up to 15 days, so long as they replenish the dry ice and don’t open it more than twice a day.
Then there is the thorny question of who will receive vaccines first. That will be up to state governments.
Pfizer has said it expects to be able to produce 50 million doses this year. The chief executives of Pfizer and BioNTech have suggested that half of those may go to the United States. Since each person needs two doses, about 12.5 million Americans could be vaccinated.
“If you’re talking about 12.5 million people, you’re going to have to make some very tough-minded decisions about who this goes to,” said J. Stephen Morrison, senior vice president at the Center for Strategic and International Studies, a research firm. “It’s a pretty small number of doses that are going to be distributed.”
One of the biggest early challenges may be distributing the vaccine in rural areas, which may not be able to administer doses quickly enough before they go bad. It isn’t clear how states with large rural populations are going to deal with this.
Industry executives acknowledge another potential hurdle: Will Americans resist the vaccine? The country has long had a noisy minority of people who oppose vaccinations. Safety concerns are only likely to be heightened by the speed with which the coronavirus vaccines have been produced.
“The challenge, of course, that’s out there is: Are people going to go get vaccinated?” Ms. Alcorn said. “It would be a shame that we did all this work, and then we don’t have the public trusting that there’s a safe vaccine.”
For all the difficulties of making and distributing the vaccine, public health experts said the hardest part of the process could soon be complete. Having devised and tested an apparently effective vaccine, figuring out the logistics is more about applying existing know-how, said Dr. Omer of the Yale Institute for Global Health.
“The good news,” he said, “is that these are not insurmountable problems.”