At first, I was confused since some of the press releases state that it was 90% effective, others stated it was 60% effective, and yet other press releases came up with an average of 70% effective. These were supposed to be the results from a single clinical trial! Remarkably, this was only the start of the confusion on this vaccine’s data.
Moderna said they can manufacture 20 million doses before the end of this year and at least 500 million doses in 2021 ... If both the Pfizer and Moderna vaccines are authorized, that would give the US 40 million doses before January.
[PODCAST] The FDA's Peter Marks, MD, PhD talks with JAMA Editor Howard Bauchner, MD on vaccine progress as of Oct. 5 and prospects for pre-election interference in the FDA approval process.
Many underlying issues need to be addressed to be able to recruit diverse communities for vaccine trials, including whether those communities will have access to a vaccine once approved, aversion to hospitals, and lack of insurance in case of needed medical care resulting from an experimental vaccine.
Emory University pediatrician Dr. Evan Anderson argues that delaying vaccine trials in children will hamper their education, health, and emotional well being as well as prolong the pandemic. "... the role of children in SARS-CoV-2 transmission has clearly been underappreciated," he writes.
Will vaccine trials answer the most important question: Will the vaccines prevent moderate and severe COVID disease? The trials look only at mild disease as the endpoint. And nothing will be known abouut their efficacy in children, adolescents, and pregnant women because these populations are excluded from trials.
Bill Gates highlights several missteps in the federal government's reposnse to the COVID-19 pandemic: "You know, this has been a mismanaged situation every step of the way," Gates told STAT News.
With very little information about the one recent serious adverse effect in the AstraZeneca vaccine trial, NIH scientists are circumspect regarding the safey of the vaccine -- not to say that it may not be safe, but they need more information before being assured that the trial should proceed in the U.S.
A podcast with editors of NEJM covering how COVID-19 vaccines are being developed, discussing a recent setback of one case of a possibe neurological adverse effect, and then talking about vaccine global deployment -- how and to whom first.
With multiple SARS-CoV-2 vaccines in testing, Pfizer may be betting that positioning itself to prevail in the long run will be a better strategy than necessarily being first to market. With multiple vaccine candiates in its portfolio, one may emerge later as more efficacious than what comes first.
These vaccines, using modified adenovirus type 5 (Ad5) viral vectors, could potentially have limited efficacy. Many adenoviruses commonly circulate in the population to cause the common cold. Thus, many people may have immunity to Ad5, eliminating the vector carrying the SARS-CoV-2 genes before it could insert its payload into cells. A group at McMaster University is developing an inhaled Ad5 COVID vaccine, "theorizing it could circumvent pre-existing immunity issues." But isn't the respiratory tract exactly where a cold virus would induce immunity?
The IDSA urges the FDA to approve and license any vaccine based on completed phase 3 trials and not through an Emergency Use Authorization. However, if the FDA issues an EUA, the IDSA urges it to use both internal and independent external experts to review full safety and efficacy data.
Two bioethicists explore the ethics, legal aspects, and what knowledge may be gained or lost when scientists self-administer untested products developed as COVID-19 vaccines.
Ezekiel Emanuel, MD, PhD, of the University of Pennsylvania's Perelman School of Medicine, Department of Medical Ethics and Health Policy, discusses logistics, policy, & ethis of COVID vaccine distribution (at 15:28-25:58; Recorded August 19, 2020)
Ezekiel Emanuel, chair of Medical Ethics & Health Policy at the University of Pennsylvania, believes a COVID vaccine will need to be given to people who have the highest risk of transmitting the virus, who are not necessarily front-line health care workers.
Excellent, inciteful compilation of and commentary on reports regarding natural and vaccine-induced immunity to SARS-CoV-2 in not-too-technical language (with links to reports)
One of the most promising therapies uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body. Early trials show signaling cells eliminate the virus, calm the immune response and repair tissue damage.
Rushing vaccine testing won't help anyone if the public doesn't have confidence in the end product. And regardless of how fast a vaccine is tested and approved, it will take time for sufficent numbers of people to be immunized, more time for protective immunity to develop, and more time for herd immunity.
Caveats and considerations in the rush to develop/approve SARS-CoV-2 vaccine: early vaccine efficacy; efficacy in vulnerable populations; "A weakly effective vaccine can do more harm than good."
The article argues for adherence to existing structures for drug/vaccine development in the quest for a SARS-CoV-2 vaccine. "...consent is not suficient for the justification of additional risk," the author asserts.
Two virologists have free-whelling discussion with Dr. Fauci about SARS-CoV-2 tranmission, testing, immunity, pathogenesis, vaccines, and preparedness.
... even without a vaccine, there is reason for hope that a medical solution to the crisis will soon be at hand. It will likely take the form of anti-Covid drugs that will be able to treat patients newly infected and prevent others from becoming ill. These drugs can likely help us bridge the gap between where we are today -- with only masks, hand hygiene and physical distancing to protect us -- to where we hope to be tomorrow -- with a vaccine in hand.
The COVID-19 outbreak in the United States will continue to "get worse before it gets better," but the situation might improve as clinicians gain a better understanding of how to treat the virus in the absence of a vaccine or a cure, experts said Tuesday.
