With Covid-19 continuing to ravage communities, Americans are anxious to discover a vaccine. This week, President Donald Trump claimed we could have a vaccine as early as mid-October something directly contradicted by Centers for Disease Control and Prevention head Robert Redfield, who predicted we might see something by the end of the year, if that. On Friday, Trump predicted more than 100 million doses of a vaccine will be available by the end of the year.
Theres an obvious political reason why Trump or other lawmakers might wish to get our hopes up about a vaccine before the November election.
Theres an obvious political reason why Trump or other lawmakers might wish to get our hopes up about a vaccine before the November election. But based on my 35 years spent developing drugs for serious medical conditions, including AIDS and sepsis, this is unlikely to happen as quickly as some politicians have told us.
Importantly, creating the vaccine is just one step. We then need to distribute it. Because while vaccinating everyone is impossible, vaccinating enough people to create a protective herd immunity is not. This is really the key when we talk about returning to normal. Youre not hearing much about that from the president because its easier to just allude to a magical vaccination that will immediately fix everything. And there is no magical solution to this problem.
Until now, the federal government has eschewed a leadership role in pandemic response. The crew that tried to derail CDCs venerable Morbidity and Mortality Weekly Report and accused the CDC of sedition has not positioned itself to be a credible force for public health. An administration that has eliminated nonpartisan careerists throughout government in favor of politically favored but professionally naive opportunists is unlikely to pull off the most significant logistical challenge ever undertaken by the government within our borders.
Vaccines are generally safe and effective because to be approved, they must go through rigorous testing. This helps keep people safer and the drug companies that make those vaccines profitable.
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Drug companies dont make money by testing vaccines, but by selling them. When a drug company says vaccines take years to develop, thats because the company wants to get the vaccine right. Some vaccines may make the disease worse, at least in some people, so proper testing is essential to protect public health. If we cut corners on testing, the risk goes up that a vaccine may be unsafe or ineffective.
But before we reach that herd immunity, we will have to clear four hurdles: clinical trials, regulatory review, filling the supply chain and getting enough people to get vaccinated.
To adequately test a vaccine, the sample population must be large enough, which in the case of Covid-19 is about 30,000 people, which may seem like a lot. However, the more people you study, the faster you can get to an answer. Since Covid-19 began in the United States in earnest in March, more than 6 million people have been infected in a nation with 330 million people. Thats about 2 percent of the U.S. population in six months. If we apply this to a study of 30,000 people, that would be about 45 cases per month in the control group and hopefully half of that with the vaccine.
Thats not a lot of people to study.
Still, Pfizer seems to have done a good job, with over 29,000 people enrolled in its study. So far, most of the possible side effects have been mild. This is encouraging and supports the CEOs statement that it could have the results of interim analysis in late October. Moderna is not far behind. However, we must keep in mind that an early report does not guarantee there will be enough data to support even an emergency Food and Drug Administration authorization, much less full approval.
For the sake of discussion, lets imagine there is a positive result announced in late October and the vaccine not only decreases viral infections, but also reduces clinical symptoms like shortness of breath and fever.
While I have great respect for the scientific integrity of Pfizers research and development group, terrible things have happened when a federal agency took a manufacturers word that its product was safe.
Therefore, the FDA will need to get the relevant vaccine trial data (this will take time) and conduct its independent review. One month to review this volume of data would be record-breaking. However, given the novelty of the product (no mRNA vaccine has ever been approved) and the shortcuts being taken for Operation Warp Speed, an independent advisory committee of medical and statistical experts will also need to review the data. If all give up their holidays, a recommendation could be made at the end of December. However, if there are any hold-ups at all, there will be a further delay.
Then the supply chain needs to be filled and the drug delivered to the professionals who will administer it.
It is reported that Pfizers product may require ultra-cold storage at minus 94 degrees Fahrenheit. This type of specialized storage is not available in your typical doctors office; it is found in universities and research centers. If the vaccine thats first out of the gate does require this kind of storage, the logistics of distribution will be daunting. Even if the military is mobilized to distribute the vaccine, the hurdles will be formidable. Suppose a second vaccine is approved rapidly. In that case, the complexity will multiply, since the vaccines are not interchangeable: You must have the same vaccine for both shots.
And how many people will need to be vaccinated? An optimistic model says 43 percent will need to have potent antibodies to achieve herd immunity, and the administration claims it will do it in one year. That is 142 million people. But if the vaccine is only 50 percent effective, it could take many more people to reach immunity. Currently, we cant get that many people to wear a mask. And an NBC News poll showed that more than half of Americans are still wary of a Covid-19 vaccine.
Nonetheless, if the federal government steps up to the job, pharmaceutical companies and the military fill the supply chain and vaccine supply is unlimited and available at every hospital with an ultra-cold freezer, each of the approximately 7,000 hospitals in the U.S. will need to vaccinate 20,000 people, two times. That will be 40,000 visits or nearly 800 per week, on top of continuing to provide their routine care.
If this overwhelming task can be accomplished, then there will only be three things left to worry about: potential rare but serious side effects that were not discovered during testing, the possibility of vaccine-enhanced infections or respiratory disease and the ever-present risk of mutation that could cause us to need to do the whole thing over again.
Dr. Kenneth Gorelick
Kenneth Gorelick, M.D., is a board-certified internal medicine and pulmonary disease specialist and a member of the Committee to Protect Medicare. He has more than 35 years of experience in the development of drugs, biologics, and medical devices in the health care sector. A former vice president of global clinical research and development at Dupont Merck Research Laboratories, Inc, he currently runs biopharmaceutical consulting company Zymo Consulting Group.
Mostly, the protocols are just thick volumes of proceduresthe instruction manuals for the trials. How big a dose of vaccine will participants in the experimental group get, and how many? How will they be monitored, and for what symptoms? For how long? What will count as an infection? How will the data be accounted for? Publishing the protocols in advance is all about accountability. These are the rules the companies plan to abide by, available for criticism but also to ensure that nobody does any shenanigans on the other end, cherry-picking data or changing what counts as success.
The details, though, also give some clues as to how the next few months will go. For one thing, both protocols take so much time to put into action that its next to impossible that a vaccine will be available before Election Day. Everyone has to get two doses, and the studies must allow enough time to monitor their outcomes.
(I emailed representatives of the other six signatories to the vaccine science pledge asking if they, too, planned to release their research protocols. Spokespeople at Johnson & Johnson, Merck, GlaxoSmithKline, BioNTech, Novavax, and Sanofi all declined to comment.)
Still, even public protocols might not be enough to get the scientific community on board. Hotez hopes the companies will release not only their protocols but also their full Phase III data. He also wonders what an EUA might mean for the other vaccine trials. Ordinarily, ethics would dictate that once a vaccine is available, trials of other candidates should stop. By definition, the risks of those trials now outweigh the potential future rewards. Except here, those other candidates might be better, safer, whatever. EUAs dont have any guidelines for that, and neither the FDA nor the president have articulated any. They might be forthcoming, but Hotez says he thinks the president is more interested in reelection than vaccines. He wants a vaccine released under EUA, sort of now, right? Hes never created a national road map or response to Covid-19, this is undermining his candidacy for reelection, and he feels he needs a victory in the area of Covid-19 to be successful, Hotez says. But I dont see a way by which wed know that vaccines were safe and effective if he tries to release a vaccine in October. So were in a bit of a standoff. The scientific community is holding a line.
It has to; theres a lot to be suspicious about. Modernas leadership has been criticized for questionable stock trades and hyping preliminary results. And in early September, AstraZeneca officials announced that they were pausing their vaccine trial due to an adverse eventsome kind of medical issue that forced the researchers to stop and determine whether it was a consequence of taking the vaccine. And it wasnt the first time. A participant got ill in the summer, but they turned out to have a neurological disorder unconnected to the vaccine. This time, an otherwise healthy 37-year-old woman developed a spinal inflammation that looked like a neurological disorder called transverse myelitis, which some scientists think could be an immune issue. Thats disconcerting when it comes to vaccines. But AstraZeneca didnt release those details on purpose; Stat got them via leaks from a presentation the company made to investors, and CNN obtained an internal report. Thats not transparency. (The trial has since restarted in the UK, and a spokesperson told me they expect it to restart in the US soon.)
And all of these political and scientific pressures combine, like separate wildfires cresting the same hill. When they swirl together with general anti-science sentiment and vaccine hesitancy, you get a fire tornado of skepticism. Thats why the trustworthiness of the science will be so important, and so important to communicateto three disparate groups of people beyond the science community. One is antivaxxers and the vaccine-hesitant. Another is the people who have little information, who may even be outside the health care system altogether. But the third group is the one thats the most interesting in this case. Theyre worried about the rush. Theyre worried about the fact that theres political pressure. So theyre going to be a little skeptical until they see pretty good evidence that the vaccine being offered is good, says Christine Grady, chief of the Division of Bioethics at the National Institutes of Health Clinical Center. Yes, you can message it. Its not easy to do, but you can. The way the trial was run, ethically and methodologically and rigorously, will matter a lot. The key is making sure that the trials are run well, and then saying so loudly enough that people believe it.
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The authorization of an effective vaccine will mark perhaps the biggest turning point in the battle against coronavirus, but only if enough people are willing to get vaccinated. There have been substantial declines in public willingness to get vaccinated against COVID-19, despite immense, unprecedented public investments in vaccine development. In one survey, barely half of Americans said they would get the vaccine as soon as it was available, numbers that will undermine the benefits of even a highly effective vaccine.
It is no mystery why trust in a potential vaccine has plummeted. Operation Warp Speed, the Trump Administrations $10 billion vaccine initiative, and other vaccine efforts have compressed processes that usually take years into months. This speed alone can raise concerns, but to date, that pace has been matched with strict adherence to the basic principles of scientific integrity. However, increasing politicization of key regulatory bodies and unexplained decisions in trial procedures threaten to undermine the entire project. We need a lot more transparency in this process to ensure that only a vaccine proven by data to be safe and effective will be approved.
Unlike medical treatments given to the sick, vaccines are given to healthy people. Historically, vaccines have been very safe and highly effective due to the rigor and care of both the scientists conducting the trials, and the regulators deciding whether to approve vaccines for public use. Even rare adverse events are carefully identified and studied. For vaccinations to work, we must be able to trust our doctors when they tell us it is time for a shot.
The coronavirus vaccine approval process has consequences that extend well beyond the pandemic. Driven by misinformation, so-called vaccine hesitancy has been growing for years. But as long as the Food and Drug Administration (FDA) could be trusted to rigorously follow the science, most of us continued to get vaccinated. That has changed in the pandemic. The politicization of the FDAapparent in the handling of the authorization of hydroxychloroquine and convalescent plasma, amongst othershas substantially damaged faith in the FDA. If the FDA again acts politically in approving a vaccine, it will further increase vaccine hesitancy. If safety concerns emerge after the vaccine has been approved, confidence in vaccines could be destroyed for a generation, in a single stroke, undoing a century of public health gains.
But restoring trust in FDA alone will not be enough. We need the companies making the vaccines, and the researchers studying the data, to act differently as well. Recently, one of the major trialsfor the Oxford/AstraZeneca vaccine, supported by more than $1 billion in public funds from Operation Warp Speedwas paused following a possible adverse reaction to the virus in a trial participant. But while the leadership of AstraZeneca mentioned the event in a private phone call with investors, they did not share the details with the public. A few days later, the trials resumed again, with little information of what changed. This will not do. Given that the American taxpayer has invested billions of dollars into these trials, and will foot the bill for billions more when the vaccine is released, the American people have a right to know much more.
Beyond more fully disclosing safety events, the pharmaceutical companies working to develop a vaccine should publish the protocols of their clinical trial protocols, as Moderna did on Thursday, so we understand how the trials are structured, if changes have been made, and why. This is essential. Further, they should publish their analysis plan so the public can see what subgroups of patients the investigators had planned to study, why, and whether their approach is sound. Each time a trial is paused tell the public what happened, how it was investigated, and why the trial was allowed to continue.
Making these critical documents public would be unusualthey usually arent made public until a trial is published. However, these are extraordinary times and failure to secure confidence in a COVID-19 vaccine would have disastrous consequences.
With just weeks until the election, the pressure on the FDA to quickly approve a vaccine will mount. But the more the timeline is politicized, the more vaccine hesitancy will grow. Transparency can stem the tide of skepticism, even if it cannot entirely extinguish the persistent current of misinformation and mistrust of science. We must practice aggressive transparency, and let the FDAs career scientists, not political appointees, make the decisions about approvals and explain those decisions to the American people.
The publics faith in the vaccine development process is a critical component of the vaccine, because vaccines dont save lives, vaccinations do. For a vaccine to help bring this pandemic under control, hundreds of thousands of healthy Americans must undergo vaccination. We need to assure them that the vaccines workand that they are safe. These are unprecedented times. They need unprecedented transparency.
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The headlines arent always kind to the National Security Agency, a spy agency that operates almost entirely in the shadows. But a year ago, the NSA launched its new Cybersecurity Directorate, which in the past year has emerged as one of the more visible divisions of the spy agency.
At its core, the directorate focuses on defending and securing critical national security systems that the government uses for its sensitive and classified communications. But the directorate has become best known for sharing some of the more emerging, large-scale cyber threats from foreign hackers. In the past year the directorate has warned against attacks targeting secure boot features in most modern computers, and doxxed a malware operation linked to Russian intelligence. By going public, NSA aims to make it harder for foreign hackers to reuse their tools and techniques, while helping to defend critical systems at home.
But six months after the directorate started its work, COVID-19 was declared a pandemic and large swathes of the world and the U.S. went into lockdown, prompting hackers to shift gears and change tactics.
The threat landscape has changed, Anne Neuberger, NSAs director of cybersecurity, told TechCrunch at Disrupt 2020. Weve moved to telework, we move to new infrastructure, and weve watched cyber adversaries move to take advantage of that as well, she said.
Publicly, the NSA advised on which videoconferencing and collaboration software was secure, and warned about the risks associated with virtual private networks, of which usage boomed after lockdowns began.
But behind the scenes, the NSA is working with federal partners to help protect the efforts to produce and distribute a vaccine for COVID-19, a feat that the U.S. government called Operation Warp Speed. News of NSAs involvement in the operation was first reported by Cyberscoop. As the world races to develop a working COVID-19 vaccine, which experts say is the only long-term way to end the pandemic, NSA and its U.K. and Canadian partners went public with another Russian intelligence operation aimed at targeting COVID-19 research.
Were part of a partnership across the U.S. government, we each have different roles, said Neuberger. The role we play as part of Team America for Cyber is working to understand foreign actors, who are they, who are seeking to steal COVID-19 vaccine information or more importantly, disrupt vaccine information or shake confidence in a given vaccine.
Neuberger said that protecting the pharma companies developing a vaccine is just one part of the massive supply chain operation that goes into getting a vaccine out to millions of Americans. Ensuring the cybersecurity of the government agencies tasked with approving a vaccine is also a top priority.
Here are more takeaways from the talk, and you can watch the interview in full (embedded above).
TikTok is just days away from an app store ban, after the Trump administration earlier this year accused the Chinese-owned company of posing a threat to national security. But the government has been less than forthcoming about what specific risks the video sharing app poses, only alleging that the app could be compelled to spy for China. Beijing has long been accused of cyberattacks against the U.S., including the massive breach of classified government employee files from the Office of Personnel Management in 2014.
Neuberger said that the scope and scale of TikToks apps data collection makes it easier for Chinese spies to answer all kinds of different intelligence questions on U.S. nationals. Neuberger conceded that U.S. tech companies like Facebook and Google also collect large amounts of user data. But that there are greater concerns on how [China] in particular could use all that information collected against populations other than its own, she said.
The NSA is trying to be more open about the vulnerabilities it finds and discloses, Neuberger said. She told TechCrunch that the agency has shared a number of vulnerabilities with private companies this year, but those companies did not want to give attribution.
One exception was earlier this year when Microsoft confirmed NSA had found and privately reported a major cryptographic flaw in Windows 10, which could have allowed hackers to run malware masquerading as a legitimate file. The bug was so dangerous that NSA reported the vulnerability to Microsoft, which patched the bug.
Only two years earlier, the spy agency was criticized for finding and using a Windows vulnerability to conduct surveillance instead of alerting Microsoft to the flaw. The exploit was later leaked and was used to infect thousands of computers with the WannaCry ransomware, causing millions of dollars worth of damage.
As a spy agency, NSA exploits flaws and vulnerabilities in software to gather intelligence on the enemy. It has to run through a process called the Vulnerabilities Equities Process, which allows the government to retain bugs that it can use for spying.
Without masks and a vaccine, we could reach Herd Immunity from COVID-19, but deaths would skyrocket. We break down the science of it. USA TODAY
I'm USA TODAYeditor-in-chief Nicole Carroll, and this is The Backstory, insights into our biggest stories of the week. If you'd like to get The Backstoryin your inbox every week,sign up here.
Bottom line: "You've got to be patient," said Jennifer Portman, USA TODAY's health editor.
This week, Pfizer, one of the companies developing a vaccine, said its test looks safeand plans to releasedata for approval at the end of October. It is expanding its Phase 3trial from 30,000 to 44,000 people, another sign that things are going well.
USA TODAY patient safety reporter Karen Weintraubexplains the phases, which start after a vaccine has been tested in a labon mice and on monkeys.
Phase 1, she said, "is a very small trial wherethey're trying to make sure they're not killing anybody. There arehints at effectiveness in Phase 1but not a lot of data. Phase 2 is a bigger trial phase. Phase 3 is the big trial."
The vaccine will be approved if on average, it is at least 50% effective in Phase 3. "Then there will be a Phase 4," she said, "which is once it's on the market, they're going to continue these trials for some time andmake sure there are no side effectssix months down the line."
Once the vaccine is approved at the end of Phase 3,there's a regulatory process. The U.S. Food and Drug Administration reviews the data,then the U.S. Centers for Disease Control and Prevention determineshow the vaccine will be distributed. Most vaccine candidates will require two doses to be effective.
"It will first go to health workers in hospitals or clinics who aretreating COVID patients," said Elizabeth Weise, a USA TODAY health and science reporter. "Maybe front-line providers, police, firefighters, the military will probably have its own section. And then it'll start coming down to people, if they got COVID, probably at highest risk of getting very sick or dying. It depends on which vaccine and whoit works best on."
The vaccine can be distributed quickly after approval because companies are already manufacturing iton the assumption theirs will be approved. If they do not get approval,they'll have to destroy all the vials waiting for distribution.
From left, USA TODAY's Karen Weintraub, Jennifer Portman and Elizabeth Weise.(Photo: USA TODAY)
The CDC document released this week says the vaccine might be available by early November but "significantly more COVID-19 vaccine may be available for distribution" beginning in January 2021.
But wide distribution?
"I definitely think that's a huge issue on people's minds," Weintraub said."When can life resume?And I think it's sometime next summer to fall."
A day later, on Wednesday, that'sexactly what CDC DirectorRobert Redfield told the Senate. Any vaccine available in November or December would be very limited and prioritized, he said.If youre asking me,When is it going to be available to the American public so we can begin to take advantage of vaccines to get back to our regular life? I think were probably looking at late second quarter, third quarter 2021.
We ask this question ofour own experts each month as well. USA TODAY created a panel of leaders in medicine, virology, immunology, logistics and supply chain issues to estimate how close we are to a vaccine.We plot their answers on a USA TODAY vaccine clock, on which midnight is the day the pandemic began and noon is the day that a vaccine is freely available to whomever wants it.
Right now, on average, our experts say we're at 7 a.m., up from 4 a.m. in June.Our panel this month was concerned about making sure that data fromthe vaccine trials is transparent, openly released to the scientific community and thoroughlyvetted.
It's a shared concern. On Sept. 3, the Biotechnology Innovation Organization issued a public letter reiterating the strict standards its members follow. Trusting science and the scientific process is the best way out of this pandemic, said Dr. Michelle McMurry-Heath, BIO's president and CEO.
Race to the vaccine:The sprint to create a COVID-19 vaccine started in January. The finish line awaits.
Fighting COVID-19: How the CDC failed public health officials fighting the coronavirus
A USA TODAY/Suffolk Poll released this month showed two-thirds of U.S. voters say they won't try to get a coronavirus vaccine as soon as it becomes available,and one in four say they don't want to ever get it.The poll, taken Aug. 28-31, surveyed registered voters.
"We know what needs to be done. And we'll tell you if it's being done or ifit's not being done," Weise said. "And then when we actually get a vaccine, we should have enough information to saythere's great data, this vaccine is safe and effective, or there was not great data and there are many questions about this vaccine.
We are not political. We'rescience writers who arejust going to say, This is what we know. This is the data we have.
Portman says the most important thing we can do, as journalists and as citizens, is follow the science,"and it's just going to take a little bit longer than any of us want."
The Backstory: Covering the record-setting wildfires that have wracked Western states
The Backstory: Our journalists' top takeaways from the Democratic and Republican conventions
You can reach Nicole Carroll at EIC@usatoday.com orfollow her onTwitterhere.Thank you forsupporting our journalism.You cansubscribe to ourprint edition, ad-free experienceor electronic newspaper replica here.
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Health Matters is a biweekly opinion column. The views expressed are solely the authors.
A vaccine that nobody wants to take is not very useful.
If there were a safe and effective vaccine against COVID, why wouldnt people take it? After all, the virus has claimed 200,000 American lives, shut down schools and businesses and affected almost every aspect of our lives. The fact that scientists have been able to develop vaccine candidates in mere months after sequencing SARS-CoV-2s genetic code is nothing short of a medical marvel. However, our countrys hyper-polarizing climate has thrust the rapid vaccine progress into the political ring, resulting in rising public distrust.
Theres a reason progress on the vaccine has been so fast. The Trump administration implemented Operation Warp Speed (OWS) five months ago, which aims to produce 300 million doses of vaccines by January 2021 with an approved budget of $10 billion.
So far, OWS results seem promising. There are nine vaccines in phase 3 trials, the final phase before submitting for FDA approval. For details on how clinical trial phases work click here. Frontrunners include Moderna and Pfizer, which use inactivated coronavirus fragments to induce an immune response, and AstraZeneca, which uses an adenovirus to carry coronavirus genes into cells, provoking an immune response.
Even with promising results, the public remains nervous. A new Kaiser Family Foundation (KFF) poll showed 62% expressing concern that political pressure from Trump would force the FDA to approve a vaccine without ensuring safety and efficacy. Less than half (46%) would get vaccinated if a vaccine were approved by the FDA before the election. Another poll from STAT echoed the KFF poll, with 78% worried that vaccine approval is driven by politics more than science.
The integrity of the FDA has been put in question, catching the ire of administration, scientists and the American public. On one hand, Trump has claimed an FDA deep state that is committed to thwart his reelection by delaying a vaccine until after the election. On the other hand, scientists and the public are increasingly skeptical of the FDA, as the agency pushed out Emergency Use Authorization (EUA) for hydroxychloroquine after Trump touted it. The EUA was later rescinded.
More recently, the day after Trump called convalescent plasma a medical breakthrough the FDA gave plasma an EUA. It was promptly pointed out that misleading statistics overdramatized plasmas benefit and the statement was later rescinded via Twitter.
The mounting criticism of the FDA being controlled by the White House reached such a fever pitch that last week, in an opinion column in USA Today, eight career scientist at the FDA made a pledge that their work would continue unimpeded and independent of political influence. They stated if the agencys credibility is lost because of real or perceived interference, people will not rely on the agencys safety warnings and later adding We and our career staff do the best by public health when we are the decision makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.
Big Pharma is far from exempt. Many scientists say these vaccine makers need to be more transparent about how vaccine trials are run and reporting adverse events. In normal circumstances, drug companies hold clinical trial results precious in order to guard intellectual property and maintain competitive advantage. However, critics say that American taxpayers are entitled to know the details since the federal government has spent nearly $10 billion as part of OWS.
The most recent example of transparency (or perhaps lack thereof) is the incidence of a rare but lethal spinal inflammatory disorder called transverse myelitis in AstraZenecas Phase 3 trial, which immediately halted the trial. Trial shutdowns are common, and perhaps this instance demonstrates that drug companies are willing to slow down warp speed for the sake of patient safety. However, many are upset is that the shutdown was announced in a closed private meeting with investors and was actually leaked by STAT News.
The drug companies know that gaining public trust will lead to more vaccinations. In fact, in an unprecedented move amongst competitors, nine pharmaceutical companies including all the heavyweights pledged to stand with science by promising to submit for EUA only after ensuring safety and efficacy. Of course, these are things we already expect from a drug company. Even more so from the FDA.
All these factors make it challenging to follow the science. I believe in vaccines, but for me (i.e., this is not a medical recommendation but a personal choice), I think I will wait several months and continue to be vigilant with masks, hand-washing and distancing. These trials typically take years (the quickest vaccine developed in history took 5 years) to demonstrate safety and Im uncertain how efficacious the vaccine will be since antibody tests, one of the measures showing if a vaccine works, are not where they need to be.
Im also concerned about logistical compliance of the vaccine, since it is two parts and the second dose is time-dependentwhat if people dont get the second dose or they take it too late? I also think that more time and money should be put towards a COVID countermeasure. As it stands, only a small fraction of the $10 billion is going towards therapeutics. Many lives could be saved if we had a Tamiflu equivalent for treating COVID.
So back to the starting quote A vaccine that nobody wants to take is not very useful, which was from AstraZeneca CEO Pascal Soriot. Increased scientific knowledge, transparency on all sides and less scientific missteps with political leanings are key to gaining my trust in taking the vaccine.
Inside information on Arlingtons COVID vaccine plan is hard to find, but I do know that plans are in motion to prepare for imminent distribution. While this article is pertinent to all Americans, it will be interesting to hear what Arlingtonians think regarding the vaccine.
Dr. George C. Hwang, known to his patients as Dr. Chaucer, is a practicing anesthesiologist who also helps to runMind Peace Clinicsin Arlington. He has written for multiple journals, textbooks and medical news outlets, and has been living in Arlington for the past 15 years.
Thats not the case with Covid-19. So far, over 25.7 million people have been infected worldwide and 857,920 have died. With the prospect of many more infections ahead, the rapid deployment of a safe and effective vaccine is all the more urgent.
The Centers for Disease Control and Prevention told public health agencies last week that limited doses of a vaccine may be available beginning in late October or November, although that would only be if a vaccine is shown to be safe and effective. According to the documents the agency sent to the public health offices, two million doses of what the C.D.C. labeled Vaccine A most likely the Pfizer vaccine may be available by the end of October, with 10 to 20 million doses possibly available by November, and 20 to 30 million by the end of December.
The C.D.C. said the other potential vaccine, Vaccine B which matches the details of the Moderna vaccine could have about 1 million doses available by October, 10 million by November, and 15 million by December. Each of the vaccines would require two doses to be effective.
Pfizer and Moderna did not respond to questions about the C.D.C.s recent guidelines.
In the documents sent to public health agencies, the C.D.C. said certain groups would have priority, beginning with health care workers, essential workers (like police officers or those who work in critical industries like food production), national security populations, and workers and residents of long-term care facilities like nursing homes.
Those priority groups include millions of people. At a meeting last week of the Advisory Committee on Immunization Practices of the C.D.C., an agency official presented a slide showing that in the United States, there are about 17 to 20 million health care workers, 60 to 80 million essential workers and about 53 million people older than 65.
On Wednesday, the National Academies of Sciences, Engineering and Medicine unveiled a 114-page plan, sponsored by the C.D.C. and the National Institutes of Health, that proposed a complicated four-phase system for priority.
Probably not. Aside from Moderna and Pfizer, there are 34 other vaccines in clinical trials worldwide. There are over 90 more vaccines confirmed to be in active preclinical testing. Over the next year, 69 of them are slated to go into clinical trials.
ROCHESTER, NY (WROC)Rochester Clinical Research is working to find an effective vaccine, by focusing on recruiting people of color, who are more impacted by the virus.
Adam Larrabee says Rochester Clinical Research is at the forefront of the search of a COVID-19 vaccine.
The most important thing that we can do right now is find a vaccine for COVID-19 to help save lives, said Adam Larrabee, president of Rochester Clinical Research, Inc.
Multiple phase 1, 2, and 3 trials are taking place at Rochester Clinical Research, and they are hoping to recruit up to 5,000 people as paid volunteers to take place in COVID-19 Vaccine Studies.
It could be eight visits over two years, the first two visits may be within the first month and then they dont come back for another 3-6 months and then theres periodic phone calls, said Larrabee.
Volunteers can make up to $150 dollars per visit. Health requirements for some of the phases are low, and researchers say they work with volunteers providing transportation and compensation for their time.
To make sure the vaccine is most effective, researchers are targeting communities of color, who are most at risk for infection.
Those are the people that 3 times at risk of being infected and 7 times more likely to die, said Larrabee. We know right now that the communities of color are being infected the most. The only chance at prevention is with a vaccine.
To learn more, you can call585-288-0890 or visit their website here.
The past half year has proven without a doubt the critical importance of a well-functioning healthcare supply chain. It has also revealed many of the shortcomings and weak links in that chain. While the procurement, transport and distribution of such items as personal protective equipment (PPE) posed one of the greatest logistics challenges of our lifetime, this will pale in comparison to an even greater task ahead of us: vaccine logistics.
Luckily, all stakeholders in the supply chain, from suppliers, to governments and NGOs and onto logistics providers, have learned much since the pandemic began. Now is the time to put these lessons into practice and prepare for the huge challenge of getting life-saving vaccines to the people of this world. As the worlds largest logistics group, we are prepared to distribute the vaccines but it all depends when the vaccine will be ready, and how prepared governments are the world over to take all the necessary measures for the final delivery of the vaccine to their citizens.
Keeping vaccines cool along the supply chain will be a major challenge
Image: DHL
It is evident that we must act quickly. Currently, there are more than 250 potential COVID-19 vaccines in various stages of development around the world, with progress being made at unprecedented speed. It is not unlikely that we could see some vaccines ready for distribution before the end of this year.
This rapid rollout is only possible if special approaches in vaccine development, testing and stabilization are used. While traditionally, sufficient time is devoted to testing and developing vaccine stability, with the tremendous urgency to deliver a successful coronavirus vaccine, this might not be the case for all of the potential candidates.
A potential lack of stability data, in turn, could mean more stringent temperature requirements for the vaccine supply chain, with some vaccines needing to be kept at temperatures as low as -80 degrees Celsius. This poses challenges for the existing medical supply chain that conventionally distributes vaccines at +28C. While health authorities, producers and logistics providers would strongly prefer to begin large-scale transport and distribution under the less stringent conditions, one of the most promising vaccines that could be produced at high capacity is likely to require such extreme care, more akin to logistics used for medical trials a system created to cater to a much lower number of units than billions of doses of a COVID-19 vaccine.
The actual transport of these vaccines will also pose a huge challenge. Due to their urgency, it is probable that at least for longer distances air freight will be needed. If we want to achieve global coverage over the next two years, that means some 200,000 pallet shipments and 15,000 flights. In the final distribution we could potentially require nearly 15 million cooling boxes, with the corresponding amounts of cooling bricks or dry ice.
Data must be available for everyone
Due to the sensitivity of the shipments, technology will play a vital role in ensuring the smooth execution along every step of the supply chain, for example to ensure that vaccines have remained efficacious throughout the supply chain. At the same time, and as the initial scramble for PPE earlier this year showed, we will need to increase the overall visibility on relevant data for everyone involved. This is not only essential to properly judge supply and demand, but also to identify potential bottlenecks that slow the transport and distribution of the vaccines.
Currently, no platform exists that covers all those visibility needs, but a number of examples exist from other areas. Ecommerce-led platforms, for example, are able to provide near real-time shipment visibility, smart routing and demand forecasting. In the forwarding industry there are data sharing platforms that are able to monitor and predict potential risks, such as volatile transportation, distressed suppliers and other disruptions. Adapting existing solutions to emergency response management could greatly ease some of the challenges experienced in the past months.
Reaching billions of people
Geography will be a defining factor in how quickly and efficiently vaccines can be distributed, and here temperature requirements are likely to be the main challenge. If vaccines need to be distributed under the more stringent scenario, especially regions with a particularly warm climate and those with limited cold-chain logistics infrastructure will pose a huge challenge this is the case in large parts of Africa, South America and Asia. In other words, if the vaccine does need this extreme care, we are currently only able to (fairly) easily reach 2.5 billion of the worlds population.
Potentially, some of these challenges can be lessened if, in the end, the vaccines that go into mass production do not need such stringent care, but even then the logistical effort will be extraordinary.
We are all in this together
So what needs to be done in the short time we still have before the first vaccines arrive?
The world has learned a lot of lessons over the past few months of this health crisis. One of them is that sufficient planning and solid partnerships make a huge difference when it comes to meeting the surge in demand for medical supplies and ensuring their effective distribution. A network with both public-private and government-to-government partnerships will be essential going forward. Every one of us has an interest in ending this pandemic as quickly as possible.
Logistics companies such as Deutsche Post DHL Group and our peers in the industry are natural partners to ensure that the countries of the world will be able to source and distribute any vaccine as quickly as possible. We and they are working hard to set up the necessary infrastructure and have the teams in place to execute the moment a vaccine arrives. Global logistics players, working in tandem with governments, NGOs and health authorities, will be able to provide governments with access to a global shipping network at scale as well as local warehousing capacity and know-how with in-country logistics. But, as mentioned at the start, much will also depend on when the vaccines will be available and how well governments around the world have prepared for the distribution of the vaccine to their people.
As part of our contribution to this endeavor, but also to stress the critical urgency of this matter, Deutsche Post DHL Group also recently published a study in collaboration with McKinsey & Company that offers an in-depth look at what the logistics challenges for medical supplies, particularly vaccines, might look like in the coming months. The white paper offers a five-pillar strategy to help stakeholders prepare for and respond to the next public health emergency.
Included in the report are also a number of recommendations for governments to support them as they prepare not only for the requirements of a well-run vaccine supply chain, but also for future crisis. These measures could entail, for example, the creation of centralized special unit within the government that has the authority to quickly and effectively decide and respond to developments, that can act agilely to an ever changing and often complex situation, and possess credibility both within the government and the public sector.
Prepared for future crisis
COVID-19 is not the worlds first pandemic, and it likely will not be the last. By working together in strong partnerships and with careful and informed planning, we can establish comprehensive public health crisis management backed by safe and sophisticated supply chains. This will help us tackle the current challenges we face, and make sure that we are well prepared to deal with any large-scale health crisis that comes our way.
In Genoa, Italy, a recovered COVID-19 patient undergoes a test of heart function.
By Jennifer Couzin-FrankelSep. 15, 2020 , 4:45 PM
Sciences COVID-19 reporting is supported by the Pulitzer Center and the Heising-Simons Foundation.
This fall, cardiologist Sam Mohiddin will embrace a new rolethat of research subject. MRI scans of his heart at St. Bartholomews Hospital in London, where he works, will help answer a pressing question: Do people who suffered a mild or moderate bout of COVID-19 months ago, as he did, need to worry about their heart health?
Fears that COVID-19 can cause the cardiac inflammation called myocarditis have grown, as doctors report seeing previously healthy people whose COVID-19 experience is trailed by myocarditis-induced heart failure. Mohiddin recently treated 42-year-old Abul Kashem, who had typical COVID-19 symptoms in April, including loss of smell and mild shortness of breath. A month later, he fell critically ill from severe myocarditis. Im just grateful to be alive, says Kashem, who spent more than 2 weeks in an intensive care unit. Why did this happen? he wonders.
How the virus might damage heart muscle is just one question researchers are now probing. Other studies are following people during and after acute illness to learn how common heart inflammation is after COVID-19, how long it lingers, and whether it responds to specific treatments. Researchers also want to know whether patients fare similarly to those with myocarditis from other causes, which can include chemotherapy and other viruses. In more than half of virus-induced cases, the inflammation resolves without incident.
But some cases lead to arrhythmia and impaired heart function, or, rarely, the need for a heart transplant. Because millions are now contracting the coronavirus, even a small proportion who suffer severe myocarditis would amount to a lot of people. Are we going to have an increase of patients with heart failure secondary to this? asks Peter Liu, a cardiologist and chief scientific officer of the University of Ottawa Heart Institute.
Whether SARS-CoV-2, the virus that causes COVID-19, induces cardiac injury including myocarditis more often, or with greater severity, than other viruses is still unclear. Because SARS-CoV-2 can trigger an intense immune response throughout the body, survivors may be at heightened risk of cardiac inflammation. Another idea suggests COVID-19 patients might be prone to the condition because the virus enters cells by binding with the angiotensin-converting enzyme 2 (ACE2) receptor, which sits on heart muscle cells. But researchers caution against outrunning the data. Its a good hypothesis, but its not a tested one, says Leslie Cooper, a cardiologist at the Mayo Clinic in Jacksonville, Florida, about ACE2.
One reason its hard to say whetherCOVID-19 poses a special risk of myocarditis is uncertainty about its prevalence after other infections. Echocardiogram studies after some influenza outbreaks suggest up to 10% of flu patients have transient heart abnormalities, Liu says. But such studies are scarce. We dont scan patients after they had the flu, says Valentina Pntmann, a cardiologist at University Hospital Frankfurt.
Pntmann fueled concerns about myocarditis when she did just that with COVID-19 patients. Her team used MRI to scan the hearts of 100 COVID-19 patients an average of 71 days after they had tested positive. The scans showed cardiac abnormalities in 78 people, with 60 appearing to have active inflammation. Most also described lingering symptoms, such as fatigue and mild shortness of breath, leading Pntmann to wonder whether heart inflammation might be responsible.
Although the work by Pntmann and her colleagues, published in July in JAMA Cardiology, prompted alarming headlines, many researchers say it needs to be replicated. Cardiologists urge anyone with symptoms like shortness of breath or chest discomfort after COVID-19 to see a doctor, but they worry about a flood of healthy recovered people clamoring for heart assessments. Heres the good news: Were going to find out how likely cardiac injury is, says Matthew Martinez, director of sports cardiology at Morristown Medical Center.
Because of the physical demands of sports, team doctors need to be on guard for myocarditis. A paper in JAMA Cardiology last week reported a study of 26 athletes at Ohio State University after COVID-19; four had developed myocarditis. Professional sports leagues are also scanning the hearts of athletes who were infected with SARS-CoV-2. Those with myocarditis, regardless of whether they have symptoms, are benched, in part out of fear that myocarditis could lead to sudden death during intense activity. Martinez, whos helping coordinate the research for the National Basketball Association and Major League Soccer, predicts a flow of data on athletes over the coming months. Those of us in this space are willing to ruin a Saturday or a Sunday to get this done.
He stresses, though, that even if researchers can clarify the average duration of myocarditis and its risks for a young athlete, those may be very different for a 50-year-old with obesity or high blood pressure, especially if they were sick enough with COVID-19 to be hospitalized. In those individuals, I am going to be more cautious and screen for heart injury, he says.
Others are pursuing clues to howCOVID-19 can damage the heart, which might point to ways to head off the damage. SARS-CoV-2 does challenge your immune system in unconventional ways, Liu says. Autopsies of heart tissue after COVID-19 have revealed inflammation in the hearts blood vessels instead of its muscle cells, the site of the inflammation caused by other infections. Another autopsy study found scattered death of heart cells, but the authors noted the mechanism of injury was unknown. Theres been a lot of discussion whether this is myocarditis as typically defined, Liu says. Regardless, he and others hope for clinical trials to test whether preventive strategies, such as taking beta blocker drugs, might head off heart failure in someone flagged as high risk after COVID-19.
While Mohiddin volunteers for a study of survivors, hes also running one: a trial that aims to recruit 140 people while they are hospitalized with COVID-19 or soon after, 20 with severe myocarditis and the rest without. He and colleagues will look for abnormal T cell levels in the blood of people with myocarditis, which could help explain whether and how the immune system is causing cardiac injury. He is also exploring whether immune cell patterns in the blood presage myocarditis later.
Even if COVID-19 rarely causes serious myocarditis, one hypothesis is that mild cases could heighten the risk of heart disease years later. Scar tissue can form as myocarditis heals, and earlier work has shown residual cardiac inflammation portends worse heart health. As cardiologists, Were in the business of identifying asymptomatic risk factors, such as hypertension, Mohiddin says. Its not difficult to imagine that in the future, clinical practitioners will ask a new patient, Did you have COVID?
