A flu vaccine is administered at a walk-up COVID-19 testing site, in San Fernando, Calif. Emergency use authorization is expected soon for vaccines for COVID-19. Robyn Beck/AFP via Getty Images hide caption
A flu vaccine is administered at a walk-up COVID-19 testing site, in San Fernando, Calif. Emergency use authorization is expected soon for vaccines for COVID-19.
Top officials from Operation Warp Speed, the government's program to fast-track the development and delivery of COVID-19 vaccines, announced they've allocated 6.4 million doses of COVID-19 vaccines to states based on their total populations.
Once a COVID-19 vaccine is authorized by the Food and Drug Administration, allocations will be made based on the total number of adults in the state. "We wanted to keep this simple," Alex Azar, secretary of Health and Human Services, said at a media briefing Tuesday. "We thought it would be the fairest approach, and the most consistent."
The allocation-by-population policy is a departure from earlier distribution plans, and it downplays the role of the Advisory Committee on Immunization Practices. The independent vaccine advisory group for the Centers for Disease Control and Prevention has proposed allocations based on high-risk groups. The CDC advisory committee had previously been central to the government's vaccine distribution plans.
At a briefing on October 23, top HHS official Paul Mango told reporters that Operation Warp Speed would send vaccines out to states based on the number of people in high-risk groups, such as health care workers, nursing home residents and factory workers, who had been identified by the CDC advisory committee.
The committee is currently working on guidelines for prioritizing these groups, which will be finalized once a vaccine is authorized by the FDA. Operation Warp Speed officials had previously said they would wait for these guidelines to be completed.
Now government officials say that's changed. Instead of waiting for the advisory committee's recommendations, they've gone ahead and allocated the first 6.4 million doses to states, based on overall population. "I finally made the decision, late Friday night," said Gen. Gustave Perna, head of logistics for Operation Warp Speed, at the briefing Tuesday. "So states could prioritize based on [their] amount," meaning how many doses of vaccine each state will receive.
HHS Secretary Azar says the way vaccines are allocated will not change once the advisory committee makes its recommendations. "At the end of the day, that is a decision of the U.S. government's to make." He added that states would get the final say in whether to abide by the government's recommendations.
Still, many states intend to follow the committee's guidance on how to prioritize limited doses, according to plans submitted to the CDC. States are currently enrolling local hospitals, doctors offices and pharmacies to be eligible to give COVID-19 shots when they're available and providers are signing agreements saying they will follow the CDC's advisory committee guidelines.
There may be valid reasons why Operation Warp Speed has changed the way it's decided to allocate vaccines and it would be helpful for the public to see how their thinking evolved, says Dr. Grace Lee, an advisory committee member. "Transparency in the process is entwined with public trust," she says, "and that's so critical to the success of a COVID-19 vaccination program, especially in a pandemic." That's why the committee has been holding monthly public meetings where members openly air their considerations and concerns.
At one such meeting Monday, advisory committee members described the importance of prioritizing vaccines for groups that bear the highest risk burdens. "I think if we're serious about valuing equity, we need to have that baked in, early on in the vaccination program," said Dr. Beth Bell, who chairs the committee's COVID-19 vaccines workgroup.
They are weighing the relative benefits and risks of vaccinating specific populations such as health care personnel and essential workers, who are more likely to be exposed to the coronavirus because of jobs requirements; and people who are older and those with underlying health conditions, who are more likely to get severely ill or die from COVID-19.
At the meeting, the committee generally supported prioritizing vaccines for workers who keep our health, food and transport systems running, ahead of those with health issues. "These essential workers are out there putting themselves at risk to allow the rest of us to socially distance," Bell said.
No vaccines have been authorized yet, but the FDA has set a December 10 meeting to consider the first application for a COVID-19 vaccine co-developed by drug companies Pfizer and BioNTech. If the vaccine is given the OK by the FDA, the government expects to begin vaccine distribution in mid-December.
A lab technician sorts blood samples for a COVID-19 vaccination study at the Research Centers of America in Hollywood, Fla., on Aug. 13. Chandan Khanna/AFP via Getty Images hide caption
A lab technician sorts blood samples for a COVID-19 vaccination study at the Research Centers of America in Hollywood, Fla., on Aug. 13.
As coronavirus cases continue to surge both in the U.S. and around the world, there's promising news on the vaccine front. Pharmaceutical companies Pfizer, Moderna and, more recently, AstraZeneca have all announced that their vaccines have shown better-than-expected results.
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital, says that a vaccine release could begin for selected populations by the middle of December and that a broader vaccination effort could soon follow.
"By the early part of next year, we're going to move pretty quickly, I think, in vaccinating a significant percentage of the [U.S.] population," Hotez says.
Hotez says that at present, all the vaccines in development work similarly, by inducing an immune response to the spike protein of the virus.
"One of the questions that I'm asked all the time is, 'Hey, doc, which vaccine are you waiting for?' And the answer is ... I'm going to take any of those vaccines that's made available to me that's authorized by the U.S. Food and Drug Administration," he says. "Don't overthink it. Don't wait. Get what vaccine you can."
Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital. Some people in the global health sector call him "Bono with a bow tie." Katie Hayes Luke for NPR hide caption
Dr. Peter Hotez is co-director of the Center for Vaccine Development at Texas Children's Hospital. Some people in the global health sector call him "Bono with a bow tie."
For two decades, Hotez and his team have worked to develop low-cost global health vaccines. Now, with COVID-19, they're working on developing a vaccine that he hopes could be produced locally, so low- and middle-income countries aren't reliant on the U.S. or Europe for production.
"We signed an agreement with Biological E., based in India, in Hyderabad, and they are now scaling this up to 1.2 billion doses, testing it across India," Hotez says. "It's very exciting for us to make a contribution. We've never made a billion of anything before so that's pretty exciting also."
Despite this good news, Hotez urges people to continue physical distancing and wearing masks.
"Don't be lax with it now, especially with the holidays," he says. "It's especially tragic if one of your loved one loses their life or has permanent, long-lasting injury during this period because it's just a matter of staying disciplined for the next couple of months and getting them to the other side."
Hotez's forthcoming book is Preventing the Next Pandemic: Vaccine Diplomacy in a Time of Anti-Science.
On his advice for the holidays: telling loved ones that visiting isn't safe this year
It's not worth that short-term event, getting family together, in order to put them at risk and put yourselves at risk. Vaccines are coming.
Dr. Peter Hotez, co-director of the Center for Vaccine Development at Texas Children's Hospital
Remember, this is a true gesture of love telling people not to come because right now ... COVID-19 [is] accelerating across the United States at this screaming-high level of approaching 200,000 confirmed cases per day, which really means about probably at least half a million new cases a day. Any airport right now, any bus terminal, any train station has lots of COVID-infected people in those venues. It's not worth it. It's not worth that short-term event, getting family together, in order to put them at risk and put yourselves at risk. Vaccines are coming. It's just a matter of recognizing we have to get everybody through to the other side.
On the U.S. pulling out of the World Health Organization and how vaccines have become nationalized
I think the scientists are still sharing information and communicating at an international level, so I don't think that's been too affected. The thing that I worry about now is people have tied national identities to vaccines. In fact, there's a new term that's been coined called "vaccinationalism." We talk about the Chinese vaccine, the Russian vaccine, the British vaccine, the American vaccine. We've never had that before. I think it's counterproductive. And so by the U.S. pulling out of the World Health Organization and refusing to be a part of the COVAX sharing facility, which is our new mechanism that's been put in place to provide global equity for vaccines, I think this has been counterproductive and could hold us back.
We also now have this unfortunate situation where countries that don't have full access to vaccines are now making one-off deals with the Russians, the Chinese, and [it] has kind of a Cold War smell to it. We have to fix that as well. I've been devoted my whole life to this concept of vaccine diplomacy, sharing vaccine development practices between countries. And I served that role as U.S. science envoy in the Obama administration. I think we have to get back to that.
On the vaccine development he's working on and why he hopes it will reach low- and middle-income countries
Medical staff along with volunteers from the Hindu hard-line group Rashtriya Swayamsevak Sangh walk through a market for a door-to-door medical screening in Mumbai, India, on June 17. Indranil Mukherjee/AFP via Getty Images hide caption
Medical staff along with volunteers from the Hindu hard-line group Rashtriya Swayamsevak Sangh walk through a market for a door-to-door medical screening in Mumbai, India, on June 17.
This is a very traditional technology. The same technology used to make the recombinant hepatitis B vaccine used all over the world. And that's important for two reasons. One, many countries have the ability to make their own hepatitis B vaccine that includes Brazil and Cuba and Bangladesh and India and Indonesia so that potentially our vaccine could be made locally. It doesn't depend on it being made in Europe or the U.S. and then filtering to the low- and middle-income countries. And it could be made pretty inexpensively, we think. So the hepatitis B vaccine, in many cases, is made for under a dollar a dose, so we think our vaccine could come along in a similar cost structure. So we're looking potentially at using this to help fill the gaps where low- and middle-income countries don't have access to COVID-19 vaccines, and possibly even a strategy for the U.S. and Europe.
On the lack of communication among Operation Warp Speed, the pharmaceutical companies and the American public
I would have liked to see more of ... a communication strategy coming out of Operation Warp Speed. The communication has been very much left to the pharma CEOs, and I think overall they've not done a good job communicating to the American people. First of all, too much reliance on press releases that over this past year have been sometimes hard to decipher or understand. Too many leaked phone calls, too much weirdness about the stock trading and options. And I think that has undermined some confidence.
I would have liked to have seen government scientists out there communicating on a frequent, regular basis about Operation Warp Speed, very much like the way [New York Gov.] Andrew Cuomo did in March and April. It doesn't have to be every day, but on a regular basis. I've done what I can to fill in those gaps, being on the various cable news networks and podcasts, but at the end of the day, I'm not a government scientist.
On how 95% mask-wearing could prevent hundreds of thousands of deaths
We have new estimates now from the Institute for Health Metrics and Evaluation at the University of Washington, really looking at the number of deaths that are going to be projected to result from COVID-19. And they're pretty chilling numbers. And that says that unless we can get to 95% mask-wearing, we're looking at another 150,000 Americans who will lose their lives between now and a week or two after the inauguration. So we have the stunning number in a terrible way of 400,000 Americans losing their lives ... by a week or so after the inauguration. That's basically the number of American GIs who died in World War II. We're looking at those kinds of numbers.
For me, the tragedy is none of those people have to die if we adhere to 95% mask-wearing No.1. No. 2: social distancing, especially in times when there's a threat of a big surge on intensive care units, because, remember, that's when the mortality figures go way up. We saw this in New York in March and April. We saw it in southern Europe and Italy and Spain in March and April. The death rates really accelerate as ICU staff starts to get overwhelmed. And that's already starting to happen now in the northern Midwest and in Lubbock and El Paso here in Texas. So just by those straightforward measures, social distancing, being responsible, wearing masks, we can save tens of thousands of American lives between now and the time of the inauguration. And that has to be our big emphasis.
On the importance of a coordinated federal government response to the pandemic
What we saw all this year in the Trump administration was putting the states in the lead and the U.S. government would be responsible for backup supply-chain management and FEMA support and manufacturing ventilators and that sort of thing. And it didn't work. And this is why the U.S. has led the world in terms of COVID-19 deaths. And the reason it didn't work is the states never had the epidemiologic horsepower to even know how to conduct COVID control measures. And they also needed the political cover of the federal government to deflect from the attacks that they were getting from their own internal political opposition. I think having the federally coordinated response, which the Biden administration seems committed to, will make a big difference.
On the difficulty of achieving herd immunity when so many people believe anti-vaccine conspiracies
If we're going to really achieve that 70% herd immunity, which is what our estimates that we came up with, together with our colleagues at City University of New York ... we need to figure out ways to better communicate about vaccines and the importance of vaccines and really start doing something about this very aggressive anti-vaccine movement that's now morphed into a wide-scale anti-science machine or empire or confederacy that really dominates the Internet and dominates American life right now. We've got to figure out a way to begin dismantling that.
On going back to "normal" life
It's not going to be a light switch. It's going to be an evolving process. We will be in a much better place by the spring, and then by the summer we'll even be in a better place, and by a year from now, life, I don't know that will entirely return to normal, but it's going to be much better than it is now.
Peter Hotez
It's not going to be a light switch. It's going to be an evolving process. We will be in a much better place by the spring, and then by the summer we'll even be in a better place, and by a year from now, life, I don't know that will entirely return to normal, but it's going to be much better than it is now. And the reason I say [life] may not entirely return to normal is we don't exactly know the performance of these vaccines in terms of reducing the amount of virus shed from our nose and mouth. ... So there still could be a fair bit of virus circulating. And that means there could be still some need for masks and social distancing and contact tracing. But, no question, life will be so much better in the next few months than it is right now.
Lauren Krenzel and Seth Kelley produced and edited this interview for broadcast. Bridget Bentz, Molly Seavy-Nesper and Marc Silver adapted it for the Web.
With three vaccine makers saying that their COVID-19 vaccines are at least 90% effective, the U.S. government is gearing up plans to distribute the shots across the country.
In a Nov. 24 briefing, members of the Department of Health and Human Services (HHS)which oversees the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)and Operation Warp Speed provided the latest information on the vaccine rollout. Most importantly, HHS Secretary Alex Azar said hes ready to work with the incoming Biden administrations transition team on vaccine rollout plans, following a decision by the General Services Administration to begin the handoff process.
I reiterated my firm commitment that the transition planning and execution will be professional, cooperative and collaborative in the best spirit of looking out for the health and wellbeing of the American people, Azar said during the briefing. He previously said that he would not initiate transition communications until the GSA decision.
Heres what the Operation Warp Speed team, which is tasked with supporting development, manufacturing and distribution of COVID-19 vaccines, revealed during the briefing:
A panel of independent experts convened by the FDA will review studies from each vaccine to determine if they are safe and effective enough to distribute to the public. First up are Pfizer and German biotech firm BioNTech, which filed an emergency use authorization (EUA) request for their COVID-19 vaccine on Nov. 20. The FDA group will meet to evaluate the shot, which the companies say is 95% effective in protecting against COVID-19, on Dec. 10.
Moderna is expected to submit a similar request to the FDA soon, and the committee will meet again to evaluate the Massachusetts-based companys application. AstraZeneca will likely follow as well.
Gen. Gus Perna, chief operating officer of Operation Warp Speed, said that he told state health departments on Nov. 20 that 6.4 million doses of vaccine will be available once the FDA issues the first EUA (at this point, Pfizers shots will most likely be the first to get the green light). What will happen if more becomes available after the initial push is, we will go out following a weekly cadence to distribute [doses] accordingly, with 40 million [doses] by the end of the year.
How much vaccine each state initially receives will be based on a rough per capita calculation.
Pfizers and BioNTechs vaccine, which is based on a new mRNA technology, needs to be kept at -70 C to -80 C. In the U.S., Pfizer has designed special thermal packaging to ship its doses. If replenished with dry ice, the doses can remain in those containers for 15 to 20 days. Once removed, the vials can be stored in a refrigerator for up to five days.
In order to train workers who are receiving the doses, Pfizer has conducted dry runs of shipping its vaccine to 10 locations. Perna said such trials would be done with all 64 public health jurisdictions receiving vaccines from the CDCmost of which are state health departmentsto make sure those administering the vaccine are comfortable handling it.
Ive personally gone through the process, put my hand in the box, pulled out trays, and timed myself in the execution, and its a very, very doable process, he said. The Pfizer containers will include 975 doses. We feel confident that if states plan dosages in the right locations, with the drumbeat and cadence of [regular manufacturing], administration of the vaccine to a minimum amount of 975 doses is very doable within 20 days, he added.
Once the first batch of vaccines are shipped, the next batch will be dispatched within 21 days for the Pfizer vaccine and 28 days for the Moderna vaccine, so people who received their first dose will be able to get their second shot. Once the manufacturing reaches a regular cadence, shipments will be distributed weekly. States will be able to order vaccines through a 24/7 system, and the doses will be shipped the following day.
Vaccine manufacturing will gradually increase as more shots are authorized by the FDA, and people will be vaccinated according to guidelines set by the CDCs Advisory Committee on Immunization Practices (ACIP), among others. The ACIP recently released principles that it says should guide who gets vaccinated first; these factors include risk as well as equity. Health care workers, first responders and others with essential jobs will be first in line, with the elderly and those with chronic health conditions next. It likely wont be until next spring or summer that the majority of the American public will be eligible to get vaccinated.
We are bridging to when we have vaccines first for the most vulnerable like health care workers, first responders and eventually the broad American population, Azar said. [Until then] wash your hands, watch your distance and wear face coverings when you cant watch your distance, and stay out of settings where you cant do those things.
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Tennessee's first shipment of highly anticipated coronavirus vaccine is expected to arrive in about three weeks, according to the state's top health official.
Pfizer's COVID-19 vaccine will be the first shipped out across the United States and should reach Tennessee around Dec. 15. Dr. Lisa Piercey, commissioner of the Tennessee Department of Health, shared the news during a briefing Tuesday.
How many doses the state will receive is fluid, but Piercey said the ballpark for the initial shipment is between 80,000 and 100,000 doses. Each person will need two doses of vaccine spaced several weeks apart, meaning the first allotment will cover between 40,000 and 50,000 people.
"This is the one ray of hope that we've got, and so we are putting a ton of effort forth to make sure we get it to you as fast and as safely as possible," Piercey said, adding that all vaccine distribution plans are subject to change.
Pfizer's vaccine is reported to be 95% effective based on late-stage clinical trials. The U.S. Food and Drug Administration is scheduled to meet Dec. 10 to discuss Pfizer's trial data and will ultimately decide whether it receives emergency use authorization, according to The New York Times.
More vaccine from another leading drug manufacturer Moderna is expected to arrive a week after Pfizer's, Piercey said.
Although the initial shipments may seem small in the context of 6.8 million Tennesseans, she said, "We're going to start to see some measurable improvement in our case trends when we get some vaccines in arms."
The welcome news comes as Tennessee and the country continue to face record numbers of new COVID-19 cases and hospitalizations.
On Tuesday, the Hamilton County Health Department reported 264 new infections and five additional COVID-19 deaths, making November the deadliest month for the virus in the county, with 29 deaths so far and six days still remaining in the month.
Hamilton County is averaging 227 new COVID-19 cases in the past week, a record, and a positivity rate of 22% for new tests in the past week, another record. As of Tuesday there were 136 people hospitalized with the virus and 30 people in intensive care units, according to health department data.
Gov. Bill Lee said during Tuesday's news conference that vaccines will be "very important for us in this state to curb the spread of the virus and to ultimately really be able to handle it."
The state will follow its draft plan to determine vaccine distribution to at-risk groups first based on supply.
Front-line health care workers and first responders those most likely to come into contact with infected people or materials will be vaccinated first. Examples include emergency department and intensive care unit staff, people conducting mass testing events and first responders who arrive at scenes without knowing the status of those they're treating.
"We need to make sure that those folks are protected so we can keep our health care workers on the front lines," Piercey said, adding that she anticipates widespread vaccine availability sometime in summer 2021.
(READ MORE: What Chattanooga area nurses treating COVID-19 patients had to say after work)
Pfizer's vaccine must be stored at an ultra-low temperature, so the state will use special coolers filled with dry ice called "thermal shippers" that hold 975 vials each in order to distribute shipments faster, rather than relying on a large stationary freezer for storage.
Contact Elizabeth Fite at efite@timesfreepress.com or follow her on Twitter @ecfite.
A volunteer participating in the AstraZeneca vaccine trial having blood drawn in Oxford, England, Nov. 19, 2020. AstraZeneca's new clinical trial results are positive but confusing, leaving many experts wanting to see more data before passing final judgment on how well the coronavirus vaccine will work. (Andrew Testa/The New York Times)
While everyone celebrated this months news that not one but two experimental vaccines against Covid-19 have proved at least 90% effective at preventing disease in late-stage clinical trials, research into understanding how the Sars-CoV-2 virus, which causes Covid-19, interacts with the human immune system never paused.
There are plenty of questions still to answer about the Pfizer/BioNTech and Moderna vaccines: how well will they protect the elderly, for example, and how long for? Which aspects of the immune response that they elicit are protective and which arent? Can even better results be achieved, with vaccines that target different parts of the immune system?
We are likely to need several Covid-19 vaccines to cover everyone and as a contingency, in case the virus mutates and escapes the ability of one vaccine to neutralise it, a real possibility in light of the discovery of an altered form of Sars-CoV-2 infecting European mink. But we also need better methods of diagnosing and treating the disease. The recent suspension of two major vaccine trials due to serious adverse events is a salutary reminder that theres much still to learn and a pandemic, while no one would wish for one, provides scientists with a golden opportunity for learning.
Like most Covid-19 vaccine candidates, the Pfizer and Moderna vaccines are injected into the muscle, from where they enter the bloodstream and stimulate the production of antibodies to Sars-CoV-2 (specifically to the protein that forms the spikes covering its surface). But antibodies are only one component of the bodys adaptive immune response, which develops over time, in response to invasion by a virus or other pathogen. There is also innate immunity, which we are born with and that is mobilised instantly upon infection, but is not tailored to any specific pathogen. There are a lot of moving parts to this, says immunopharmacologist Stephen Holgate, of the University of Southampton in the UK, who wonders why scientists have focused on so few of them.
The UK governments joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:
1 All those 80 years of age and over and health and social care workers.
2 All those 75 and over.
3 All those 70 and over.
4 All those 65 and over.
5 Adults under 65 at high at risk of serious disease and mortality from Covid-19.
6 Adults under 65 at moderate risk of at risk of serious disease and mortality from Covid-19.
7 All those 60 and over.
8 All those 55 and over.
9 All those 50 and over.
10 Rest of the population.
Holgate is one of the founders of Synairgen, a University of Southampton spin-off company that has been testing inhaled interferon-beta, an important innate defence that works by shutting down viral replication, as a treatment for Covid-19. A major international study backed by the World Health Organization, called Solidarity, showed that interferon-beta was not effective in treating hospitalised patients, but more recently Synairgen has published the results of a small pilot study suggesting that given in patients with milder disease and inhaled rather than injected under the skin it enhanced recovery.
The reason bats are able to harbour these viruses in such large numbers is that they have such a strong interferon response, Holgate says. That is why they dont develop disease. Synairgen is now testing whether interferon-beta can prevent hospitalisation in patients who inhale it soon after testing positive, at home. If the approach works, he says, the advantage is that it will continue to do so even if the virus mutates, since interferons action does not depend on the structure of the virus.
Another immune response that has received a lot of attention in the context of Covid-19 is that of T-cells. Along with B-cells, which generate antibodies, T-cells form part of the adaptive immune system and they perform two main functions: they help B-cells do their job and they kill infected cells. Both B- and T-cells retain a memory of past infections, meaning they are mobilised more quickly when a pathogen appears for a second or subsequent time.
In May, US researchers reported that T-cells extracted from human blood samples taken before 2019, and exposed to Sars-CoV-2, showed a memory for coronavirus infection. This suggested that previous exposure to different coronaviruses, such as those that cause the common cold, might be sufficient to prime T-cells and raised hopes that they could protect against Covid-19. Those hopes were bolstered by a report of people fighting off infection even though they developed only a T-cell response and no antibodies, though the number of patients in that study was small and the evidence therefore hard to interpret. Lockdown sceptics pointed to these studies as evidence that more of the population was protected against Covid-19 than was thought, but some immunologists say they did so prematurely.
As Akiko Iwasaki of Yale University in the US explains: T-cells cannot prevent infection, they can only respond when there is an infection. So although they could potentially reduce the severity of the disease, they cant stop its transmission between people. Also, there is still no proof that the T-cell response is helpful. Its likely that both antibodies and T-cells are important in protection, but we have zero evidence so far for protection of any kind, says immunologist Zania Stamataki of the University of Birmingham in the UK.
Obtaining that evidence will involve seeing how people either exposed to the virus naturally or vaccinated against it respond upon reinfection. Vaccine trials could provide such evidence, as could a number of studies of the correlates of protection in natural infection. Iwasakis group, for example, is comparing the immune responses of unexposed, sick and recovered individuals, while virologist Florian Krammer of the Icahn School of Medicine at Mount Sinai, New York City, and colleagues are tracking those responses longitudinally, in thousands of people exposed naturally over time. Then there are the so-called challenge trials that are due to be launched by Chris Chiu of Imperial College London and colleagues in January.
In the first stage of these trials, about 30 young, healthy individuals will have their immune status measured before and after deliberate exposure to Sars-CoV-2. The trials will generate data on immune responses in the blood, but also, because the virus will be delivered via the nose, on any local immune response that develops there. Both antibodies and T-cells are made at the bodys mucosal membranes, including those lining the airways, as well as in the blood, and this mucosal immunity is causing excitement among some scientists, though vaccine makers have so far paid it scant attention.
The virus comes in and it lands on your mucosal surfaces, explains Krammer. If its neutralised right there, its game over. Unable to replicate and penetrate deeper into the bodys tissues, the virus is prevented from causing not only disease but also infection, meaning the person can transmit it no further. Its not yet clear if the Pfizer and Moderna vaccines block transmission, as well as preventing disease, but a vaccine that did so could bring the pandemic to an end sooner. And it could do it without the need for an injection just by using a nasal spray or inhaler.
Antibodies come in different forms that vary according to their biological properties and the tissues in which they are expressed. Like the Pfizer and Moderna vaccines, most Covid-19 vaccines in development elicit IgG antibodies in the blood, but the main antibody secreted in the upper respiratory tract, essentially the nose and throat, is IgA.
In June, in a study that has now been accepted for publication in a peer-reviewed journal, a French group detected IgA antibodies in the blood of Covid-19 patients as early as a day after the onset of their symptoms. IgA levels peaked three weeks later, a week before IgG peaked. Then in August, a Canadian group reported the same finding in saliva. The IgA response comes up early and dissipates quickly, whereas the IgG response persists, says immunologist Jennifer Gommerman of the University of Toronto, one of the lead authors on that study.
The short duration of that IgA response might not matter as much as the fact that it peaks early within a day or two of the innate response. The adaptive immune system kicks in if that innate response fails its the second line of defence but if you could enhance that early IgA response you could still block infection and prevent the person from feeling ill at all. Researchers have some reason to hope this may be possible.
IgA occurs in different forms at the mucosal membranes and in the blood. In the blood, it circulates singly, while at the membranes lining the airways it is secreted in pairs or even clusters. There is some evidence that doubled up, IgA antibodies capacity to neutralise the virus increases significantly, probably because each pair has twice as many binding sites at which to capture the invader. If you have an antibody on its own, it works pretty well, says Guy Gorochov of the Sorbonne University in Paris, who led the French study of IgA. If you have a pair of them, it is far more effective.
An inhaled vaccine against flu that elicits a local immune response in the airways already exists and there are Covid-19 vaccines in development that do the same, though they are a long way from clinical trials. Researchers are intrigued by the possibility that, besides antibodies, such a vaccine could also stimulate a kind of T-cell that is produced in the lining of the respiratory tract, called tissue-resident memory T-cells, and that these could contribute to shutting down infection rapidly. Whats more, measuring this local response could give an early and accurate indication of a persons capacity to fight off the disease. The work weve done in the past, with other respiratory viruses, suggests that IgA in the nose is often a much better correlate of protection than circulating antibodies, says Chiu.
Theres a lot more work to be done before the human immune response is fully leveraged to fight Covid-19 and what is learned in the context of this disease could be applied to others, especially when it comes to therapies that modify the human immune response rather than the virus. For now, though, most experimental vaccines and therapies target antibodies, which are virus-specific and one type of antibody, IgG, in particular. One piece of good news, where these are concerned, is that several studies, including Gommermans and Krammers, have now demonstrated that IgG levels remain high for up to eight months after infection. The same durability of antibody response has yet to be demonstrated for any vaccine, but these findings bode well.
The best news of all is that at least two vaccines now exist that seem to protect us against Covid-19 and that the chances are high that some of the most vulnerable people in the world will benefit from them within months. It remains an extraordinary and unprecedented feat to have built such a vaccine, and shown it to be safe and effective, before the disease they protect against is one year old and before the pandemic is over.
There were more than 144,000 new cases of Covid-19 reported among children last week, the American Academy of Pediatrics (AAP) said Monday.
Over the last two weeks, there has been a 28% increase in child Covid-19 cases and children now account for more than 11% of all confirmed coronavirus cases in the US, according to the AAP.
About 144,145 new cases among children 17 and under were reported from November 5 to 19, AAP said.
Now doctors are pleading for Americans to stay home to avoid a similar fate next year.
"What most concerns me now is, you know, the immediate situation with people traveling from different places, coming home for Thanksgiving," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said during an interview with the PBS Newshour.
"When you leave a location and have to go to an airport or wherever it is, a train station, etc., the possibility of exposing yourself and then going home to your home community for a wonderful traditional Thanksgiving holiday might actually, unfortunately, be a source of, or even amplification of, the surge."
Nationwide, new Covid-19 hospitalizations are soaring at unprecedented rates -- threatening reduced care for even those who don't have coronavirus.
"Look, the virus doesn't care how much you love people," said Dr. Jonathan Reiner, a professor at George Washington University School of Medicine. "So let's stay safe this year."
"This Thanksgiving is going to suck a bit. We need to be careful, and we need to take care of each other, which means we should really have Thanksgiving for people that we live with."
Millions of travelers ignore CDC's guidance
"What is at stake is the increased chance of one of your loved ones becoming sick and then being hospitalized and dying around the holidays," said Dr. Henry Walke, Covid-19 incident manager for the CDC.
Yet more than 1 million travelers passed through security at America's airports on Sunday, according to the Transportation Security Administration.
That's the second day since Friday that more than 1 million passengers traveled through airports.
"These people are infecting each other, and they're going to infect the people that they're having Thanksgiving with. And there will be consequences in terms of disease and death as a result of what you're seeing today."
Testing can be very helpful for finding positive cases, so the infected person knows to stay home and isolate.
People who recover still have 'post-Covid syndrome,' Fauci says
A percentage of people who recover from Covid-19 experience a set of symptoms -- a post-Covid syndrome -- that is raising concern, said Fauci.
Fauci was especially concerned for those who got seriously ill and were admitted into an ICU, even if it wasn't for Covid-19.
"Anyone that goes through that is not going to feel perfectly normal for a considerable period of time," Fauci said during a live video interview with The Washington Post national political reporter Robert Costa on Monday.
Health experts are finding anywhere from 20% to 30% of people who have had symptomatic disease "have what's called a post-Covid syndrome," Fauci said. The exact percentage isn't known yet, but a larger cohort study is being done, he said.
"Namely, they no longer have virus in them, they can't infect anybody, but it takes them anywhere from weeks to months -- and maybe even beyond -- to feel perfectly normal," he said. "They have a constellation of symptoms and signs that seem to be consistent when you talk to different people."
These symptoms can include extreme fatigue, shortness of breath -- even among people who are athletes -- temperature control problems, sleep disturbances and sometimes what is described as brain fog, or difficulty focusing or concentrating.
Fauci also told the Post he doesn't necessarily agree with states like New York and California reviewing Covid-19 vaccine data separately for themselves.
"I can understand, though I don't agree with they're doing that," Fauci told the Post. "I would hope that if they do that, they do it in an expeditious manner that doesn't delay anything."
States crack down after nationwide surge
Unlike previous surges that pummeled certain hot spots in the US, "Covid-19 is everywhere" now, emergency medicine physician Dr. Leana Wen said.
"It's out of control. It's running rampant in communities around the country," she said Monday.
And the rate of new infections has consistently outpaced the rate of new testing, according to data from the Covid Tracking Project.
In Nevada, cases are rising at "wildfire level," Gov. Steve Sisolak said. He announced new restrictions that will begin Tuesday, including a mask mandate indoors and outdoors, limiting private gatherings to 10 people or less and requiring restaurants seat no more than four people at each table.
In North Carolina, Gov. Roy Cooper tightened mask requirements as the state adds 10 more counties to its "critical" list for Covid-19 spread, according to a news release from Cooper's office. The new requirements make it clear that everyone needs to wear a mask whenever they are with someone who is not from the same household, the release said.
The new requirements will also add the mask requirement to several additional settings including any public indoor space even when maintaining 6 feet of distance, gyms even when exercising, all schools public and private and all public or private transportation when taveling with people outside of the household.
The new guidelines in North Carolina will go into effect Wednesday, and remain in place until December 11.
Maryland Gov. Larry Hogan announced Monday that the Maryland State Police is expanding its Covid-19 compliance and coordination center and deploying high visibility compliance units across the state.
"Additional state troopers will be assigned in every single county to work in partnership with county leaders, county health departments, liquor boards, licensing and permitting departments, as well as municipal and county law enforcement agencies to investigate any reports of violations of state law," Hogan said.
Beginning on Thanksgiving Eve, the high visibility compliance units "will be detailed to popular downtown areas, main street areas, in places including Bel Air, Towson, Salisbury, Silver Spring, Baltimore City, and two other spots around the state," Hogan said.
And in California, Los Angeles County officials are preparing to announce a "targeted safer-at-home order" this week that would only allow residents to leave their homes for essential work and services for a three-week period, County Health Director Barbara Ferrer said.
The new restrictions come after the county surpassed a daily average of more than 4,500 cases over a five-day period.
Brooklyn pier stores hundreds of dead bodies of Covid-19 victims
Many of the bodies are those whose families have not been located, or whose families cannot afford to pay for burial or funeral services, according to the WSJ article. The Office of the Chief Medical Examiner's office in New York confirmed the details of the Journal report to CNN.
"Supporting families and helping facilitate respectful final arrangements for individuals who passed at the height of the pandemic reflects the core mission of the Office of Chief Medical Examiner," Chief Medical Examiner Dr. Barbara Sampson said in a statement to CNN.
WSJ, citing the New York State Funeral Directors Association, reported that the average cost of funeral arrangements in New York is between $6,500 and $9,000. New York City only provides $1,700 in burial assistance to residents, an increase of $800 since May.
"Those who we lost, their families are still trying to determine the best way to provide services for them, and just have been struggling because of the pandemic challenges," Mayor Bill de Blasio said Monday. "We're trying to work with each and every family of those we lost during that situation to make sure that they can have the kind of services they want at the right time."
More good news on the vaccine front
Doctors say Americans won't need to hunker down forever -- just for the coming months, until vaccines help the country get closer to normal.
The US Food and Drug Administration set a December 10 meeting for the Vaccines and Related Biological Products Advisory Committee to discuss possible emergency use authorization, FDA Commissioner Dr. Stephen Hahn tweeted on Sunday.
"Measures that include wearing masks, frequent hand washing, maintaining physical distance and restricting the size of gatherings will remain crucial," the Infectious Diseases Society of America said.
Reiner said he normally celebrates Thanksgiving with people from different households, but "we're not doing that this year."
"It's just my family, hunkered down, because the stakes are simply too high," he said.
With promising news about vaccines, "there is a bright light coming," he said.
"But for now, we need to get to that point. So let's stay safe. Let's try and push the curve down a little bit. Protect our health care workers and protect each other, so that we can really have a great celebration next year."
CNN's Jenn Selva, Hollie Silverman, Naomi Thomas, Maggie Fox and Pete Muntean contributed to this report.
In the past 7 days, the state has reported more than 53,000 -- meaning three times more Floridians have tested positive in the past week than in the week before the reopening.
As the US grapples with the worst month yet in the pandemic for coronavirus infections and hospitalizations, Florida is nearing 1 million cases. As of Monday morning, the state had reported 938,414 infections, according to data from Johns Hopkins University.
In an effort to curb the spread of the virus, a bipartisan group of mayors from across the state asked DeSantis last week to issue a mask mandate, bolster contact tracing, increase funding for Covid-19 testing, and give mayors more local control.
While DeSantis issued a video message sharing "promising news" about therapeutics and vaccines, he did not address the increase in cases in his state.
When the governor reopened the state, many of the local leaders raised objections.
Miami-Dade County Mayor Carlos Gimenez said he intended to keep restrictions in place despite the order, and Orange County Mayor Jerry Demings said he was disappointed he did not know about DeSantis' executive order until the news conference.
"As we deal with this pandemic, everything happens at a local level, this is where the rubber meets the road. And in order for us to be effective at dealing with the virus, we have to have good communications across the state," Demings said, adding that his office received calls from "numerous businesses" seeking clarity following the governor's statement.
"What they've done is opened up everything as if nothing had ever happened there and you and I could be talking probably in eight to 10 weeks, and I will likely bet that Florida will be a house on fire," Osterholm told CNN's Jake Tapper.
CNN's Sara Weisfeldt contributed to this report.
This free webinar will be held at 6 p.m. ET on Dec. 1.
The experts at the MJH Life Sciences COVID-19 Coalition will turn their attention to the question of coronavirus testing in a new free webinar.
At 6 p.m. ET on Dec. 1, the coalition will discuss the questions of diagnostic vs. antibody tests, at-home vs. point-of-care, sensitivity vs. specificity, and all other facets of testing past or current COVID-19 infection.
Sign up for the free webinar, Innovative Testing Strategies for COVID-19, here.
The coalition sprang from MJHs mission to improve quality of life through healthcare communications, education, and research, the MJH Life Sciences COVID-19 Coalition was formed to help keep healthcare professionals up-to-date and informed on the science and latest learnings on COVID-19.Leveraging relationships with top thought leaders across a variety of key specialties, the Coalition generates the most accurate, up-to-the-minute information on the pandemics ever-evolving impact on healthcare professionals and the patients they treat. For more information on the MJH Life Sciences COVID-19 Coalition, visitmjhlifesciences.com/covid19-coalition.The speakers at this webinar will be:
Updated: 7:30 a.m.
Pharmaceutical company AstraZeneca said Monday that late-stage trials showed its coronavirus vaccine was up to 90 percent effective, giving public health officials hope they may soon have access to a vaccine that is cheaper and easier to distribute than some of its rivals.
The results are based on interim analysis of trials in the U.K. and Brazil of a vaccine developed by Oxford University and manufactured by AstraZeneca. No hospitalizations or severe cases of COVID-19 were reported in those receiving the vaccine.
AstraZeneca is the third major drug company to report late-stage results for a potential COVID-19 vaccine as the world anxiously waits for scientific breakthroughs that will bring an end to a pandemic that has wrought economic devastation and resulted in nearly 1.4 million confirmed deaths.
Pfizer and Moderna last week reported preliminary results from late-stage trials showing their vaccines were almost 95 percent effective. But, unlike its rivals, the AstraZeneca vaccine doesn't have to be stored at ultra-cold temperatures, making it easier to distribute, especially in developing countries.
I think these are really exciting results, Dr. Andrew Pollard, chief investigator for the trial, said during a news conference. Because the vaccine can be stored at fridge temperatures, it can be distributed around the world using the normal immunization distribution system. And so our goal to make sure that we have a vaccine that was accessible everywhere, I think weve actually managed to do that.
The Oxford-AstraZeneca vaccine is also cheaper. AstraZeneca, which has pledged it wont make a profit on the vaccine during the pandemic, has reached agreements with governments and international health organizations that put its cost at about $2.50 a dose. Pfizers vaccine costs about $20 a dose, while Moderna's is $15 to $25, based on agreements the companies have struck to supply their vaccines to the U.S. government.
All three vaccines must be approved by regulators before they can be widely distributed.
Oxford researchers and AstraZeneca stressed that they aren't competing with other projects, and that multiple vaccines will be needed to reach enough of the world's population and end the pandemic.
Were not thinking about vaccinations working in terms of one person at a time. We have to think about vaccinating communities, populations, reducing transmission within those populations, so that we really get on top of this pandemic, said Sarah Gilbert, a leader of the Oxford research team. And thats what it now looks like were going to have the ability to contribute to in a really big way.
AstraZeneca offices and the corporate logo in Cambridge, England, in July.
Alastair Grant | AP Photo file
The results come as a second wave of COVID-19 hits many countries, once again shutting businesses, restricting social interaction and pummeling the world economy.
AstraZeneca said it will immediately apply for early approval of the vaccine where possible, and it will seek an emergency use listing from the World Health Organization, so it can make the vaccine available in low-income countries.
The AstraZeneca trial looked at two different dosing regimens. A half-dose of the vaccine followed by a full dose at least one month later was 90 percent effective. Another approach, giving patients two full doses one month apart, was 62 percent effective. The combined results showed an average efficacy rate of 70 percent.
The vaccine uses a weakened version of a common cold virus that is combined with genetic material for the characteristic spike protein of the virus that causes COVID-19. After vaccination, the spike protein primes the immune system to attack the virus if it later infects the body.
The vaccine can be transported under normal refrigerated conditions of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit), AstraZeneca said. By comparison, Pfizer plans to distribute its vaccine using specially designed thermal shippers that use dry ice to maintain temperatures of minus-70 degrees Celsius (minus-94 degrees Fahrenheit).
Peter Openshaw, professor of experimental medicine at Imperial College London, said the finding that a smaller initial dose is more effective than a larger one is good news because it may reduce costs and mean more people can be vaccinated.
The report that an initial half-dose is better than a full dose seems counterintuitive for those of us thinking of vaccines as normal drugs: With drugs, we expect that higher doses have bigger effects, and more side-effects, he said. But the immune system does not work like that.
The results reported Monday come from trials in the U.K. and Brazil that involved 23,000 people. Late-stage trials are also underway in the U.S., Japan, Russia, South Africa, Kenya and Latin America, with further trials planned for other European and Asian countries.
AstraZeneca has been ramping up manufacturing capacity, so it can supply hundreds of millions of doses of the vaccine starting in January, Chief Executive Pascal Soriot said earlier this month.
Soriot said Monday that the Oxford vaccines simpler supply chain and AstraZenecas commitment to provide it on a nonprofit basis during the pandemic mean it will be affordable and available to people around the world.
This vaccines efficacy and safety confirm that it will be highly effective against COVID-19 and will have an immediate impact on this public health emergency, Soriot said.
British Health Secretary Matt Hancock said he felt a great sense of relief at the news from AstraZeneca.
Britain has ordered 100 million doses of the Oxford vaccine, and the government says several million doses can be produced before the end of the year if it is approved by regulators.
Just months ago, the idea that by November we would have three vaccines, all of which have got high effectiveness I would have given my eye teeth for, Hancock said.
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