Pfizer dose provokes ‘strong’ immune response in previously infected Nearly 3.7 million Israelis have received at least one dose of the coronavirus vaccine. https://www.jpost.com/health-scienc...-response-in-those-previously-infected-658669 People previously infected with coronavirus had a strong immune response after receiving only one dose of the Pfizer vaccine, opening the debate as to whether one dose may provide enough protection for this group It also shows that not having detectable antibodies after recovering from the virus does not necessarily mean that protection is lost. The study, conducted by Bar-Ilan University and Ziv Medical Center was published Thursday in the journal Eurosurveillance. It showed that 17 Ziv staff members who were infected with the coronavirus anytime between one and 10 months prior to vaccination developed or showed increased antibodies regardless of whether or not they had detectable antibodies against the virus before. In total, 514 Ziv staff members participated in the study, though the majority of them had not been diagnosed with the virus. Antibody levels of all participants were measured before and after vaccination. “This finding can help countries make informed decisions regarding vaccine policy,” said Prof. Michael Edelstein of the Azrieli Faculty of Medicine at Bar-Ilan, who led the study. He also said that it opens the debate as to whether one dose of the vaccine may suffice – at least for the 107 million people worldwide who were previously infected. “In some countries, this will be a very important question,” Edelstein added. “In countries where they don’t have enough vaccines, they could vaccinate more people with just one dose.” Edelstein stressed that he is not advocating one dose for people who never had coronavirus. The United Kingdom has been working to inoculate everyone over 70 as well as frontline healthcare workers with at least one dose of the Pfizer vaccine by sometime this month. Britain also chose to stretch out the time between vaccine doses from the 21 days recommended by Pfizer to up to 12 weeks with the goal of giving at least one dose to more people, more quickly. Edelstein said that Britain is also not advocating only one dose, but for delaying the second dose. Israel has continued to follow the Pfizer protocol. Israel has had more than 710,000 Covid-19 cases. So far, nearly 3.7 million Israelis have received at least one dose of the vaccine. The Bar-Ilan/Ziv study included Jews, Arabs and Druze. The immune response was similar across ethnicities. Edelstein did emphasize that this is only a preliminary study of a small group and that more research would need to be done before drawing definitive conclusions. “It is too small to bring definitive answers,” Edelstein said, “but it raises interesting questions that need to be answered with bigger studies.”
Pfizer vaccine found to give strong immune response to new Covid variants Study finds patients have strong T-cell response after one jab, and second boosts antibody response https://www.theguardian.com/world/2021/feb/11/pfizer-vaccine-strong-response-new-covid-variants People who have received two doses of the Pfizer vaccine have been found to have strong T-cell responses against the Kent and South African variants of Covid, suggesting that the vaccine will continue to protect against serious disease in the coming months. In the first study to test immune responses against the variants circulating in populations, researchers found that although antibody responses against the new variants were blunted, they may still be high enough to protect most people from becoming infected, after a second dose of vaccine has been given. Although previous studies had suggested that antibodies from those vaccinated with the Pfizer/BioNTech jab could recognise and neutralise viruses carrying some of the individual mutations found in the South African and Kent variants – albeit at slightly lower levels compared with previous variants – these were tested on engineered viruses rather than ones isolated from real patients. These studies also did not look at T cells, which annihilate virus-infected cells and support the production of antibodies. Both immune responses help provide lasting protection after vaccination, but antibody responses are easier to measure. William James, a professor of virology at the University of Oxford, and his colleagues took blood samples from people who had recovered from Covid-19, and health workers who had received either one or two doses of the Pfizer/BioNTech vaccine. They also obtained isolates of the B117 and B1.351 virus variants first identified in Kent and South Africa, and of an older variant similar to those circulating a year ago. Antibodies and T cells from the individuals were then tested against these viruses to see how well they performed. The study, which has not yet been reviewed by other scientists, found that people’s antibodies were moderately effective against the original virus after their first dose of vaccine, less effective against the Kent variant, and were unable to neutralise the South African variant. However, they had strong T-cell responses against all known variants after the first jab. “It may not necessarily protect you against infection, but it’s very likely that this first dose will make it much easier for your immune system to make a good response the next time around,” said James. “We think this is why that second dose produces such a good strong antibody response, because the T cells are already there, ready to react.” The discovery that people who have recovered from Covid-19 and those who have received at least one dose of vaccine possess T cells capable of responding to the new variants is encouraging, because it suggests the T cells are recognising different regions of the spike protein to the antibodies. It could imply they will be more resilient to future variants. “It doesn’t promise you won’t get ill from the new variants, but it does suggest there’s something to work from and that your immune system can respond to them,” said James. People’s antibody responses were also boosted by the second Pfizer jab. “In more than 90% of cases, the antibodies that people are generating after the second dose are up at the sort of level that neutralises the virus and which we would expect to protect them from infection,” said James. “We’re pretty confident that they’ll be protected from infection by the South African strain and the Kent strain, as well as the [original] strain of the virus. “This virus hasn’t finished evolving, but I think that as long as the vaccines get rolled out, and people get those second doses, we’re going to be in a much better position by the summer than we are now,” said James. Deborah Dunn-Walters, a professor of immunology at the University of Surrey, said: “It does look like good news and suggests it is really important that people go back for their second dose of vaccine.” Prof Paul Morgan, the director of the Systems Immunity Research Institute at Cardiff University, said: “I was supportive of the pragmatic decision to delay second doses to get more people immunised as quickly as possible and I still am. However, this work shows that the broad immune response needed to deal with current and future variants of concern is really dependent on boosting. “I think that the message is to get the second doses going as soon as possible – perhaps as soon as the high-risk groups have all had first doses, which means pretty soon.” The findings also shed light on the risk of reinfection with new variants for people who have already recovered from Covid-19. T-cell activity was detected in all of them, but there was widespread variation in their antibody responses. “In the best responders, you could still measure some neutralisation against even the South African strain, but those who had rather weaker responses had no neutralisation activity,” said James. “It shows it’s really important to get vaccinated, even if you’ve think you’ve recovered from the virus.” Although they did not look at immune responses from people injected with other types of Covid-19 vaccines, James suspects they will generate similar immune responses. Morgan said: “The findings add to the growing confidence that the current vaccines will have a large impact on the course of the pandemic, whether by completely protecting from or markedly ameliorating disease.”
Fauci: Vaccines for kids as young as first graders could be authorized by September https://www.mprnews.org/story/2021/...irst-graders-could-be-authorized-by-september This story was originally published by ProPublica, a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox. Children as young as first graders may be able to get the coronavirus vaccine by the time school starts in September, presuming trials are successful in those age groups, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in an interview with ProPublica. “We’re in the process of starting clinical trials in what we call age de-escalation, where you do a clinical trial with people 16 to 12, then 12 to 9, then 9 to 6,” Fauci said. When asked what was the youngest age group that might be authorized for the vaccine by September, he said, “I would think by the time we get to school opening, we likely will be able to get people who come into the first grade.” As optimistic as Fauci is, several pediatricians and infectious disease experts said they wish the pediatric trials would move more quickly. In addition to restoring stability to the education system and parents’ work schedules and keeping kids and those around them safe, vaccinating children is essential to helping the country, as a whole, reach herd immunity and decrease the threat of new variants. Otherwise, “we’re going to have tens of millions of individuals in our communities that are able to maintain the virus. And when that happens, what that allows is for these unusual variants to emerge that may have the ability to evade our immunity,” said Dr. Buddy Creech, associate professor of pediatrics and director of the Vanderbilt Vaccine Research Program. Despite the need, Pfizer is the only manufacturer whose pediatric vaccine trials are far enough along to potentially have data on elementary-school age children by the end of the summer. Pfizer has finished enrolling participants in its study of 12- to 15-year-olds and anticipates having data in “the early part of 2021,” according to a spokesperson. “From there, we will plan to finalize our study in 5-11-year-olds,” she added. As Pfizer completes its trials in adolescents, then 5- to 11-year-olds, it’ll need to submit the data to the Food and Drug Administration for review and get authorization for the vaccine’s use in those age groups before it’s available; currently in the U.S., the vaccine is indicated only for those ages 16 and up. Moderna is still enrolling participants in its trial for adolescents ages 12 to 18, and it is “on track to provide updated data around mid-year 2021,” the company said in an emailed statement. Stéphane Bancel, Moderna’s chief executive officer, has said that the company’s goal is to have data from the adolescent study in advance of the 2021 school year. Moderna said it’ll begin an age de-escalation study in children ages 11 years to 6 months this year, but Bancel has said that the company doesn’t expect clinical data until 2022. Johnson & Johnson hasn’t started any pediatric studies yet. “We are in discussions with regulators and partners regarding the inclusion of pediatric populations in our development plan,” a spokesperson said. Novavax, similarly, hasn’t begun any trials in children, and a company spokesperson said it couldn’t share any details at this time. The University of Oxford, which partnered with AstraZeneca in developing a vaccine, will begin tests in 12- to 18-year-olds next month, according to Bloomberg News. The American Academy of Pediatrics has been “really advocating to try and make these trials happen with the same urgency that they happen for adults,” said Dr. Sean O’Leary, who is vice chair of its committee on infectious diseases. The manufacturers will need to prove vaccines are safe and effective in younger bodies. The adult trials paved much of the way, but researchers still need to study how kids’ immune systems react and to confirm the optimal dosage. And even if the shots are authorized by September, there will need to be enough supply on hand in order to get school children immunized before school doors open. It’s essential to act expeditiously, O’Leary said. “I would love to see a vaccine available for all children in time for the next school year.” Why it’s important to vaccinate kids against COVID-19 Early on in the pandemic, some thought that children might be entirely immune. That’s clearly been disproven. Out of more than 20 million U.S. cases where age information is available about 2.2 million, or 11 percent, have been in children under 18. Some get very ill, though this is rare. As of Feb. 8, the Centers for Disease Control and Prevention has tracked more than 2,000 cases of what’s known as multisystem inflammatory syndrome in children (MIS-C), a serious condition associated with COVID-19 that can result in cardiac dysfunction and kidney injury; 37 percent of the cases recorded were in Latino children and 32 percent in Black children. It’s also become evident that children are capable of transmitting the virus to some extent. On one hand, kids aren’t superspreaders: COVID-19 is clearly dissimilar to influenza or the common cold virus, Vanderbilt’s Creech pointed out. “You put one of those in a classroom, then in a few days, it’s overrun,” he said. “That’s not what we see with COVID.” But exactly how infectious children are remains somewhat unclear, in part because schools have not been fully open, making it hard to gather data, said Dr. Yvonne Maldonado, a pediatrician and professor of global health and infectious diseases at Stanford University. Studies from other countries, while informative, may not always extrapolate well to the U.S., she added. So while the “preponderance of data” points to children being less likely to infect people when compared with adults, “they certainly do,” said O’Leary, who is also a professor of pediatrics at the University of Colorado School of Medicine. “So, if you’ve got vulnerable people in the household and your 7-year-old comes home with COVID, it’s not to say they can’t give it to anybody else. They absolutely can. It’s just a bit less likely.” It’s important to note that the vaccines have only been proven — so far — to prevent disease and not infection (data on that is harder to gather and takes longer to prove), which means it’s not guaranteed yet that vaccinated individuals can’t spread the coronavirus. But there are some inklings of hope that vaccination can at least reduce onward transmission. So if this bears out, the more people who are vaccinated in a community, including children, the more likely transmission will drop overall. “Our current chaos about children not being in schools is just terrible for children, and I think a lot of the concern would be assuaged if children were immunized,” said Dr. Sarah Long, professor of pediatrics at the Drexel University College of Medicine. “That doesn’t mean to me that they can’t get the infection or transmit it every once in a while, but it would reduce those possibilities tremendously.” Long is also a member of the CDC’s Advisory Committee on Immunization Practices, where she has been reviewing the trial data and helping to make recommendations on how the vaccines should be used. She continued: “There are real virus control reasons, there are real societal reasons and there are economic reasons, because if children can’t go to school, people can’t work.” O’Leary said children as young as 6 months, which is the youngest age that Moderna plans to test, can get vaccinated so long as trial data shows the vaccines to be safe and effective. Infants under 6 months are likely to be protected by antibodies transferred through the placenta if the pregnant mother is vaccinated, he added. How the vaccine will be studied in kids The pediatric vaccine trials will not be as large as the final stage adult trials, which enrolled 30,000 or more participants, giving a placebo to half and the vaccine to half. Pfizer’s 12- to 15-year-old study has enrolled 2,259 participants and Moderna’s adolescent trial is a similar size, aiming for about 3,000 participants. In both trials, some teens will receive a placebo. That’s enough to prove safety and benefit, experts said, in part, because the adult trials have already paved the way. To show the vaccine is safe, among the many things that Pfizer is tracking includes the percentage of participants reporting “local” reactions such as pain at the injection site, redness and swelling, as well as the percentage of participants reporting systemic reactions such as fever, headache, chills, vomiting, diarrhea, muscle pain and joint pain. After the trials are completed, tracking for any safety issues will continue in the real world as physicians and patients will be encouraged to report to the FDA and CDC any side effects they think may be due to the vaccine. Doctors said they’d want to make sure that there are no signs that the vaccine overinflames the immune system or causes any allergic or autoimmune responses. “I think most people that are developing these vaccines feel like the vaccine is not going to trigger MIS-C, but it’s something that will be monitored for very closely both in the trials and more importantly, post-licensure,” added O’Leary, from the University of Colorado. Maldonado said she’ll also be on the lookout for any cases of Guillain-Barré syndrome, which is often a concern when it comes to vaccines, but she noted that no significant increases in cases were seen in any of the adult trials. When it comes to proving benefit, the pediatric trials will focus on a different metric than the adult trials. The adult trials’ primary efficacy measure was to compare how many vaccinated people wound up sick with COVID-19 symptoms compared with those who received the placebo and whether the vaccine impacted the severity of illness. Since children rarely are hospitalized due to COVID-19, the vaccine’s ability to reduce severe cases would be hard to measure unless the trials enrolled an enormous number of children. Instead, Pfizer’s and Moderna’s adolescent trials will focus on evaluating participants’ immune response by measuring antibodies, according to Pfizer’s spokesperson and Moderna’s clinical trial website. Scientists haven’t yet identified an “immune correlate of protection,” which is usually defined to be the level of antibodies in the blood at which they can feel confident that a person is going to be protected from infection. Some vaccines that have been approved, like the one for measles, have an immune correlate of protection identified, while others don’t. In the absence of a definitive immune correlate of protection, the trials would compare antibody levels in children with those found in adults and extrapolate that the efficacy should then be similar. The FDA and advisory groups like the CDC’s Advisory Committee on Immunization Practices would then need to discuss whether the evidence is compelling. If scientists are able to identify an immune correlate of protection, however, “and you can demonstrate that kids get that with the vaccine, that’s even more satisfying,” O’Leary said. One final difference in pediatric studies is the potential for lower doses. Moderna has said that it will run its studies of children under 12 testing lower doses first. “As we go down in age, we give the smallest possible dose of vaccine that we think is reasonable, and then we steadily increase until that point when we get that magic ‘Goldilocks’ level at which it works great and the side effects are tolerable,” Vanderbilt’s Creech explained. “I don’t think one dose fits all.” A call to speed pediatric trials Some pediatricians and infectious disease experts said they were eager for pediatric studies to move faster. “My understanding is that the entity formerly known as Operation Warp Speed had a lot of involvement with those adult trials, but with pediatric clinical trials, they’re not having the same degree of involvement,” O’Leary said. “So it’s more up to the manufacturers, and from my perspective, these manufacturers don’t have the financial incentive to conduct these trials with the same urgency that they did with the adult trials.” Stanford’s Maldonado added that she’s concerned that there’s not as much pressure on the manufacturers to recruit children of diverse backgrounds as there was for the adult trials. “I think it’s important to get those kids in to understand factors around the actual vaccine and also to get buy-in of those communities where we’re seeing more hesitancy. We want to make sure they are feeling comfortable about being represented,” she said. While O’Leary is not as confident as Fauci that we’ll see Pfizer’s data on younger kids by September, he feels very optimistic about the availability of a vaccine in the coming months for kids as young as 12, who tend to get sicker than the younger age group. “I think that’s a really big deal,” he said.
COVID-19: Vaccines giving 67% protection after three weeks, large-scale research shows The findings from an app for reporting COVID symptoms suggest one jab gives higher protection than previously thought. https://news.sky.com/story/covid-19...ree-weeks-large-scale-research-shows-12217943 One dose of a COVID-19 vaccine gives 67% protection after three weeks, a leading epidemiologist has said. Professor Tim Spector of King's College London, who runs the ZOE COVID-19 surveillance app, said data collected from 50,000 users vaccinated with either the Pfizer or Oxford/AstraZeneca jab showed one dose gave 46% protection after two weeks, rising to 67% after three to six weeks. The app uses information submitted by more than four million users across the world to predict and track coronavirus infections across the UK and other countries. "We have now got about a third of a million people who have logged their first dose of the vaccine with us on the ZOE app," Prof Spector told Sky's Sophy Ridge on Sunday. "We are showing very low levels of side effects and we've showed that after three weeks we're getting a 67% protection against the virus, so three times less risk than you'd be getting otherwise compared to an unprotected control. "That is a better rate than people had thought just on a single jab so I think that, combined with the data we're seeing, has given me a lot of reason to be optimistic that we are going to be in a much better place in two to four weeks' time and can start to reduce some of these restrictions." Asked about the sample size, he said: "We have analysed around the first 50,000 people so it is a large sample and these are healthcare workers who are at high risk, so they are the ones you would see changes in most and we're seeing a consistent fall, with no protection at all in the first two weeks… but after two weeks it drops to around 46% and after three to six weeks it is 67%, which is really great.
Israel 70% vaccinated and the daily new cases took a big dive https://www.google.com/search?client=firefox-b-1-d&q=israel+covid+cases UAE 50% vaccinated and the daily new cases also started to drop a stone https://www.google.com/search?client=firefox-b-1-d&q=uae+covid+cases
CDC says no safety problems with Pfizer, Moderna Covid vaccines after first month https://www.nbcnews.com/health/heal...-pfizer-moderna-vaccines-after-first-n1258367 The two Covid-19 vaccines approved for use in the United States have reassuring safety profiles with no concerning new issues found in data collected from the first month of vaccinations, the Centers for Disease Control and Prevention said on Friday. After administration of 13.8 million doses of the Pfizer-BioNTech and Moderna vaccines to the U.S. population, most reports indicated non-serious side effects of the type that had been expected, such as headaches and fatigue. No deaths have been attributed to the vaccines, the data showed. The CDC collected data between Dec. 14, 2020 and Jan. 13, 2021 from both an existing national surveillance system for adverse events and its own safety monitoring system established for Covid-19 vaccines. During that time, 6,994 reports of adverse events after vaccination were recorded in the national surveillance system with 90.8 percent of them classified as non-serious and 9.2 percent as serious. Rare cases of anaphylaxis, a severe allergic reaction requiring medical attention, were reported with both vaccines at a rate of 4.5 cases per million doses administered, down from the agency's previously reported rate of 5 per million doses administered. The rate of anaphylaxis linked to Covid shots is similar to other vaccines, CDC director Dr. Rochelle Walensky said Friday during the White House Covid-19 Response Team briefing. "Healthcare providers and vaccine recipients can be reassured about the safety of Pfizer and Moderna Covid-19 vaccines," the CDC said in its Morbidity and Mortality Weekly Report. A total of 113 deaths were reported, including from death certificates and autopsy reports. No causal link between Covid-19 vaccination and fatalities was found, according to the CDC report.
Pfizer to ship 13 million COVID-19 vaccine doses per week to U.S. by mid-March, says executive https://www.reuters.com/article/us-health-coronavirus-usa-vaccines-idUSKBN2AM2LW Pfizer Inc expects to deliver more than 13 million doses of its COVID-19 vaccine per week to the United States by the middle of March, more than doubling its shipments from early February, a top Pfizer executive said in prepared testimony ahead of a Tuesday congressional hearing. Pfizer is on track to deliver 120 million doses of its two-dose regimen by the end of March, said John Young, Pfizer’s chief business officer. Pfizer is also prepared to provide a total of 300 million shots to the United States by the end of July and has raised global production expectations for 2021 to at least 2 billion doses, he said. In his own prepared remarks, Moderna Inc President Stephen Hoge said the drugmaker plans to deliver 100 million doses of its two-dose shot by the end of March, and 300 million by the end of July. Johnson & Johnson believes it will be able to ship at least 20 million doses of its single-dose shot to the United States by the end of March after receiving U.S. regulatory authorization and 100 million doses by mid-year 2021, said Vice President of Medical Affairs Richard Nettles. The comments were prepared ahead of a U.S. congressional hearing on vaccine availability to be held by the House Committee on Energy and Commerce on Tuesday as the United States crossed the staggering milestone of 500,000 COVID-19 deaths. The remarks put the United States on track to receive 240 million doses by the end of March, enough to inoculate 130 million Americans, and 700 million doses by mid-year. AstraZeneca Plc, which is running a U.S. trial for its coronavirus vaccine, believes it can quickly adapt its shot to new variants of the virus in its laboratory, said Ruud Dobber, company president, North America. A highly contagious COVID-19 variant has become prevalent in South Africa and has turned up in several U.S. states.
Why The Johnson & Johnson Vaccine Has Gotten A Bad Rap — And Why That's Not Fair https://www.npr.org/sections/corona...e-has-gotten-a-bad-rap-and-why-thats-not-fair Two COVID-19 vaccines are being distributed in the U.S. right now, and this week an FDA advisory committee will vote on whether a third should join them. If granted emergency use authorization, Johnson & Johnson's one-dose vaccine would become available in the U.S., along with those from Pfizer and Moderna. In clinical trials, the Johnson & Johnson vaccine appears to be 66% effective at preventing moderate to severe cases of COVID-19 — compared to about 95% for Moderna and Pfizer. That has some people wondering if they should avoid the Johnson & Johnson vaccine. Absolutely not, says Dr. Ashish Jha, dean of the Brown University School of Public Health. "What I've been saying to my family is, as soon as the J&J vaccine is authorized, if that's what you can get, you should get it as soon as it's your turn in line," says Jha. He points out that the 66% vs. 95% effectiveness isn't the right comparison for several reasons. He notes that the Johnson & Johnson vaccine was tested in different settings — the U.S., several Latin American countries and South Africa, where some worrisome variants of the virus were first seen. "So that 66% number really represents an amalgamation of a variety of different clinical trials. Moderna and Pfizer were not tested in those circumstances," Jha tells All Things Considered. "And even if you just look at the U.S. data, the Johnson & Johnson number then starts getting much closer to the Moderna and Pfizer numbers." But all of that misses what Jha says is the most important point. "What you care about is hospitalizations and deaths," he says. "And Johnson & Johnson appears to be just as good as Moderna and Pfizer at preventing those." Jha notes that among the vaccines that have reported results, almost all of them — including the Johnson & Johnson vaccine — have shown to be close to 100% effectiveat preventing hospitalizations and deaths. In excerpts from his interview, Jha discusses the advantages of the Johnson & Johnson vaccine and how that might affect distribution. Are there other significant differences among the vaccines? Johnson & Johnson has the huge advantage of being one shot. So that's, of course, really helpful. There are a lot of differences in storage. The Johnson & Johnson vaccine can be stored basically in any refrigerator. [The Pfizer vaccine is shipped and stored at ultracold temperatures.] So transportation, widespread availability, much easier. But I certainly think for most people, the idea of a single-shot vaccine should be attractive for a lot of folks. And that also makes it easier for people to get. As people organizing this vaccination effort look at which vaccine should go where, does the ease of administering a one-shot vaccine that can be kept in a refrigerator determine where the Johnson & Johnson vaccine is going to go? I think you're going to see that play out. The two-shot Pfizer vaccine is particularly hard to manage in, let's say, rural settings, hard-to-reach places. Doable, but harder. J&J vaccine — much, much easier on that front. There are also certain people who may just decide they'd rather get a single shot than two shots. And, you know, and that may also influence who ends up getting what. Some people are expressing concern that the vaccines that appear to be more effective — Moderna, Pfizer — are going to go to constituencies that have more political power, more clout, a louder voice, and that the so-called less effective vaccine, Johnson and Johnson, is going to go to more disenfranchised groups. What's your response to that? First of all, I want to make the case that the J&J vaccine is not a lesser vaccine. And second is we absolutely should not be distributing these things based on socioeconomic status or any of those things. We should really be getting all these vaccines out everywhere, we should be focused on disenfranchised groups, actually, for priority because they've been hit so hard.
America First, Biatches! And by the way have you forgotten that Russia, China, and India are producing billions of doses. Why don't you whine about them making it hard to get doses? The U.S. Is Making It Harder for the Rest of the World to Get COVID Vaccines https://slate.com/technology/2021/02/us-covid-vaccines-covax-global-south.html As we enter the second year of the pandemic, all eyes are on the COVID-19 vaccination effort. In the U.S., the vaccine rollout has been plagued with logistical issues as states have been left to create their own distribution plans without adequate resources. Despite former President Donald Trump’s promise to vaccinate 20 million people by the end of 2020, only about 2.8 million Americans received the vaccine before the turn of the year. Upon taking office, President Joe Biden announced his goal to vaccinate 100 million people within his first 100 days of office, and last week, the U.S. government secured another 200 million doses to be delivered by the end of July. In discussions of U.S. vaccine rollout, scarcity has been the major theme: There aren’t enough vaccines to meet demand, and people who need them most—health care workers, people of color, front-line workers, those over 65—can’t get access. But compared with much of the world, the U.S. is doing quite well. We’ve administered the most doses of any country, and are fifth when it comes to doses per capita. Meanwhile, many countries haven’t even begun their vaccinations, and the U.S. is making it harder for them. That additional 200 million doses the U.S. secured brings the country’s reserved vaccine dose count to 1.2 billion doses, according to data compiled by the Duke Global Health Innovation Center’s Launch and Scale Speedometer. There are currently 60 countries and multinational coalitions with confirmed reservations for vaccine doses; the U.S.’s share is greater than the combined reservation of 45 of those entities. For comparison’s sake, Pakistan’s population is roughly 68 percent of the U.S.’s, but its vaccine reservation is 17.5 percent of the U.S.’s. “The [vaccine] scene globally is one of inequity, which is what we’ve been worried about for some time now,” says Krishna Udayakumar, founding director of Duke Global Health Innovation Center. When it comes to vaccine doses, it seems rich countries are only getting richer, squashing opportunities for less wealthy countries to access the vaccine. According to the Economist Intelligence Unit, some countries may not see a significant portion of their population vaccinated until 2024. Like Udayakumar alluded to, global health experts have been anticipating this possibility since the beginning of the pandemic. In June, the World Health Organization, along with partners the Coalition for Epidemic Preparedness Innovations and Gavi, the Vaccine Alliance, released a plan called COVAX to pool nations’ resources for developing and purchasing COVID-19 vaccines. At the time, investing in vaccine development was a risky proposition; it was a gamble whether any of the more than 100 vaccines in development would be safe, effective, and make it to market. COVAX allowed countries to pool resources and buy into a “portfolio approach”—their contribution bought into a pool of vaccine investments. “You could aggregate demand and use market power to get better prices for vaccines,” says Udayakumar. Once a vaccine was available, doses would be distributed to all participating countries at the same rate, based on their total population, according to a Gavi explainer written in September. But as soon as promising vaccine trial results were released, rich countries directed their resources away from COVAX and toward pharmaceutical companies directly. “Rather than COVAX being the major platform purchasing vaccines, what we saw instead was that most countries in the world decided to go out and buy or reserve vaccine doses on their own bilateral deals,” says Udayakumar. Wealthier countries had the political and financial power to negotiate deals directly with Pfizer, Moderna, and AstraZeneca, often issuing emergency use orders that expedited the procurement process. Of the 8.2 billion confirmed vaccine doses purchased so far, more than 7 billion have come directly from such deals, with just 1.1 billion through COVAX. “There’s only so much capacity in the world to produce those vaccines, and that capacity was tied up by a few rich countries; there was nothing left over for the rest,” says Leena Menghaney, global intellectual property adviser for the Médecins Sans Frontières Access Campaign. To Menghaney’s point, the U.S. has individually secured more doses than COVAX. Our supply is nearly enough to vaccinate the entire U.S. population at least twice over and constitutes nearly 15 percent of the world’s total confirmed purchases. These bilateral deals not only decrease immediate access to vaccine doses but also weaken COVAX’s negotiating and buying power. “Acquisition through bilateral agreements is to the exclusion of others,” says Safura Abdool Karim, a public health lawyer in South Africa and member of the African CDC’s African Vaccine Delivery Alliance. Pharmaceutical companies know they can strike big deals with wealthy countries directly, so they have little incentive to make deals with COVAX. As a result, vaccine doses are now concentrated primarily in North America and Europe. “By the middle of this year, you’ll have high-income countries vaccinating 30 to 40, even half of their population, while developing countries will still not barely reach 3 percent of the population,” says Menghaney. On Friday, the U.S. pledged to donate $4 billion to COVAX and encouraged other wealthy nations to do the same, but this came only after the country had already secured its own direct deals with companies. These wealthy countries are also blocking another potential avenue to improve vaccine access: waiving intellectual property rights on COVID-related technologies. Most vaccine developers are private companies, so the vaccines are their intellectual property. There’s a long-standing debate about intellectual property in general in global health circles—while some point to IP as a way to provide incentives for investment in innovative products, there are downsides to giving companies all the power when it comes to vaccine manufacturing and distribution. IP can be a barrier for manufacturers that want to create generic versions of the vaccine, which could increase supply but, to big companies’ detriment, drive down their prices. Those generics would give buyers—in this case, countries—some leverage in negotiations with companies; they could realistically threaten to import generics or create their own, says Abdool Karim. In October, India and South Africa called on the World Trade Organization’s Council for Trade-Related Aspects of Intellectual Property Rights, or TRIPS, to recommend that the organization issue a waiver freeing WTO member countries from having to implement copyright and patents on COVID-19 technology and products. The two countries cited an article in the Marrakesh Agreement, which established the WTO, that allows for the suspension of intellectual property rights in “exceptional circumstances.” (And what is this pandemic if not exceptional?) A month later, Kenya, Mozambique, Pakistan, and Eswatini signed on to the TRIPS waiver as co-sponsors, and according to Médecins Sans Frontières, 100 countries have “welcomed or fully supported the proposal.” But wealthy nations like the U.S., EU, Japan, and Australia have opposed it. “Countries and pharma companies work together; that’s been the story of Pfizer and the U.S., Bayer in Germany,” says Menghaney. “[Governments] see this as undermining commercial interests of companies.” The waiver proposal will be discussed at the next meeting of the Council on TRIPS on Tuesday. If the WTO does invoke a TRIPS waiver—which some experts, like Udayakumar, are not optimistic about—the change won’t result in more vaccine capacity immediately. Even if IP rights are waived, vaccines won’t be made overnight; investments in manufacturing capacity, like buildings, machinery, and trained workers will take months, if not years, to pay out. The continuing vaccine scarcity has left countries scrambling for any doses they can procure. As countries become more desperate, they’re considering a wider pool of vaccines than before. “Those have varying levels of transparency in the data behind them but have gone through, to date, less regulatory scrutiny than others,” says Udayakumar. (In particular, Russia’s Sputnik V and China’s Sinopharm vaccines have been popular but controversial choices.) In South Africa, for instance, the issue of vaccine supply has become a hugely political issue, says Abdool Karim. As countries like Hungary and Egypt have bought millions of these less-vetted vaccines, the South African public is wondering why its government wasn’t more proactive about buying doses—but such discussions don’t always include the nuances of which vaccines are available and whether those that are would pass regulatory scrutiny. In the midst of this criticism, the South African government pivoted away from using AstraZeneca’s vaccine after evidence emerged that it could be less effective against the 501Y.V2 variant. It has also announced it would begin administering the still-unapproved Johnson & Johnson vaccine to health care workers as part of a study. In addition to an initial batch of 80,000 doses, the country has secured at least 9 million more. But the number of doses available is just one factor in the race to secure vaccines; countries and regional coalitions are also trying to find ways to boost their position in the vaccine distribution queue. “It’s starting to matter less whether you purchased 100 million doses or 10 million doses, and [more] when are you in the queue for delivery relative to others who have purchased,” says Udayakumar. How, exactly, countries are negotiating this is opaque because those terms are laid out in contracts, but details available to the public indicate that the timing of vaccine delivery drives countries’ political moves. “We saw some of this play out publicly in the spat between the EU and the U.K., where AstraZeneca had to reduce supply to the EU because of manufacturing challenges in their EU-based plant,” says Udayakumar. “We’re also starting to see the purchase of vaccines with specific dates in mind,” like the African Union negotiating deals with Pfizer, Johnson & Johnson, and AstraZeneca for delivery of 670 million doses, with distribution to begin in the next few weeks. As the pandemic drags on, questions about equitable vaccine distribution and IP will only become more important. With new variants, it’s possible vaccines will require boosters or the development of a seasonal vaccination, which means we’ll need to hone existing systems for vaccine distribution. “It’s hard enough to say we need to get one round of vaccinations out to almost everyone in the world, but orders of magnitude more difficult to say we need to do that over and over,” says Udayakumar. “We’re going to have to see through these investments in manufacturing and make sure we’re scaling up all our other resources, including supply chain access to train workforce, all the supplies, data systems to track who has received vaccines and who hasn’t.” And to take an even longer lens on vaccine equity, it’s important to remember that resources put toward the issue are finite. For the past year, the world has diverted significant resources toward tackling COVID’s challenges, often to the neglect of other public health challenges. “It’s not just about this pandemic for resource constrained countries; it’s actually about the fragility and protection of their overall health care system and the health and well-being of their entire population,” says Abdool Karim. “What’s the long-term impact of a pandemic when there’s a whole system being strained?”
If only we had an international organization to work on the international needs of poorer countries. We could call it the World Health Organization or something zippy like that. We fund most of it, and Biden just gave them another 2 billion for vaccines, and, as I said at the time, that we would then be accused of doing nothing but America first stuff. I see all the lefties coming to say that Trump withdrew from the WHO. There is a reason for that. They are not supposed to working with the chinese to create and allow worldwide pandemics. No, that is not the goal. Having said that. I support neither Trump's nor Biden's positon. I would not have withdrawn, I would have demanded re-organization. And I would not have done what we knew Joe would do, which was just to give them back their funding and then put another 2 billion on top just to prove that he is not Trump but not demanding any reform of the WHO and dislodging it from Chinese Party control. I also stand by my earlier statements over and over again that WHO will be using American money to buy Chinese vaccines approved under WHO's covax vaccine program. Pretty easy for me to stand by it, considering we are only about two weeks away now. Definitely good to be China these days. Definitely.