Your coronavirus update for November 12; stay up to date with Elite.
More than 50 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Monday evening, including at least 1.26 million deaths. Healthcare officials in the United States have reported more than 10.1 million positive COVID-19 cases and at least 238,000 deaths. Source: Johns Hopkins University & Medicine
Pfizer & BioNTech Release Significant Vaccine Trial Results
Officials with Pfizer Inc. and BioNTech have announced that their mRNA-based vaccine candidate against the virus that causes COVID-19 has demonstrated evidence of efficacy in nearly all participants without prior evidence of SARS-CoV-2 infection. The results come based on the first interim efficacy analysis conducted on Nov. 8 by an external, independent data monitoring committee (DMC) from a Phase 3 clinical study, according to a joint press release distributed Nov. 9.
After discussion with officials with the U.S. Food and Drug Administration (FDA), the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases, according to company officials. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases. The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90% at seven days after the second dose. According to Pfizer and BioNTech officials, the results mean that protection is achieved 28 days after vaccine initiation, which consists of a two-dose schedule. As the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide, officials said.
“Today is a great day for science and humanity,” said Dr. Albert Bourla, Pfizer’s chairman and chief executive officer (CEO). “The first set of results from our trial provides the initial evidence of our vaccine’s ability to prevent COVID-19. We are reaching this critical milestone in our vaccine development program at a time when the world needs it most, with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen. With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”
The Phase 3 trial began July 27 and has enrolled nearly 44,000 participants to date, nearly 39,000 of whom have received a second dose of the vaccine candidate as of Nov. 8. Approximately 42 percent of global participants and 30 percent of participants in the United States have racially and ethnically diverse backgrounds. The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease. In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well. The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learning and comparison between these novel vaccine platforms. An updated version of the study protocol can be found online.1
Pfizer and BioNTech officials say they are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential emergency use authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech officials are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced, according to the press release. Based on current projections, the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021. Pfizer and BioNTech officials also plan to submit data from the full Phase 3 trial for scientific peer-review publication.
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19,” said Prof. Ugur Sahin, BioNTech co-founder and CEO. “This is a victory for innovation, science and a global collaborative effort. When we embarked on this journey 10 months ago, this is what we aspired to achieve. Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
Cough Sounds May Predict COVID Diagnosis, Researchers Claim
There’s evidence that the sound of one’s cough could be a sign as to whether they are infected with asymptomatic COVID-19, according to researchers at MIT. These differences in coughing are not decipherable to the human ear; however, they can be picked up by artificial intelligence (AI), researchers have concluded.
According to a recent paper published by the IEEE Journal of Engineering in Medicine and Biology, the MIT team reports on an AI model that distinguishes asymptomatic people from healthy individuals through forced-cough recordings, which people voluntarily submitted through web browsers and devices such as cellphones and laptops.
The researchers trained the model on tens of thousands of samples of coughs, as well as spoken words. When they fed the model new cough recordings, it accurately identified 98.5 percent of coughs from people who were confirmed to have COVID-19, including 100 percent of coughs from asymptomatic individuals — who reported they did not have symptoms but had tested positive for the virus — researchers claim. The team is reportedly working on incorporating the model into a user-friendly app, which if approved by the U.S. Food and Drug Administration (FDA) and widely adopted could potentially be a free, noninvasive prescreening tool to identify people who are likely to be asymptomatic for the virus. A user could log in daily, cough into their phone, and instantly get information on whether they might be infected and therefore should confirm with a formal test, according to MIT researchers.
“The effective implementation of this group diagnostic tool could diminish the spread of the pandemic if everyone uses it before going to a classroom, a factory, or a restaurant,” said Brian Subirana, a research scientist in MIT’s Auto-ID Laboratory, in a prepared statement.
In April, the research team began collecting cough recordings, including those from COVID patients. A website has been established where people can record a series of coughs, through a cellphone or other web-enabled device. Participants also fill out a survey of symptoms they are experiencing, whether or not they have COVID, and whether they were diagnosed through an official test, by a doctor’s assessment of their symptoms, or if they self-diagnosed. They also can note their gender, geographical location, and native language.
To date, more than 70,000 recordings, each containing several coughs, amounting to some 200,000 forced-cough audio samples, have reportedly been collected.” Around 2,500 recordings were submitted by people who were confirmed to have Covid-19, including those who were asymptomatic, researchers say. The team reportedly used the 2,500 COVID-associated recordings, along with 2,500 more recordings that it randomly selected from the collection to balance the dataset. Researchers used 4,000 of these samples to train the AI model and the remaining 1,000 recordings were then fed into the model to see if it could accurately discern coughs from COVID patients versus healthy individuals. This research is supported in part by Takeda Pharmaceutical Company Limited, according to MIT officials.
The AI model is not meant to diagnose symptomatic people, as far as whether their symptoms are due to COVID or other conditions such as flu or asthma. The tool’s strength lies in its ability to discern asymptomatic coughs from healthy coughs, researchers claim. The team is reportedly working with a company to develop a free pre-screening app based on the AI model and is partnering with several hospitals around the world to collect a larger, more diverse set of cough recordings to help train and strengthen the model’s accuracy. Ultimately, they envision that audio AI models could be incorporated into smart speakers and other listening devices so that people can get an initial assessment of their disease risk potentially on a daily basis.
Cases In Children Said To Be Rising Again
Although commonly said to be not as significant among young people, coronavirus incidence is said to be increasing in children, according to the American Academy of Pediatrics (AAP). Officials said they have found more 61,000 children tested positive for the virus towards the end of October, the highest since the pandemic began, according to the AAP.
As of Oct. 29, there have been 853,635 COVID-19 cases reported in children, a new report from the AAP claims. Children have represented more than 11 percent of all cases of the virus in the country and nearly 200,000 new child COVID-19 cases were reported, in October. Children also represented 1 percent-3.4 percent of total reported hospitalizations, and between 0.6 percent and 6.4 percent of all child COVID-19 cases resulted in hospitalization, according to the report.
References
1. Coronavirus Scientific Resources. Pfizer. 2020. Accessed online: www.pfizer.com/science/coronavirus
2. Children and COVID-19: State-Level Data Report. AAP. 2020. Accessed online: https://services.aap.org/en/pages/2019-novel-coronavirus-covid-19-infections/children-and-covid-19-state-level-data-report/
