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The Manual is compiling some of the most significant news items regarding COVID-19 to help people stay up to date.

News items through April 2021 compiled by Fred R. Himmelstein, MD, FACEP. News items compiled after April 2021 compiled by Richard B. Lynn, MD.

                                


  November 10, 2021

BNT162b3 COVID-19 vaccine in children 5 to 11 years old

The data from the clinical study on the Pfizer-BioNTech COVID-19 vaccine (mRNA) in children 5 to 11 years of age was published in the New England Journal of Medicine on November 9, 2021. In June 2021, a total of 2,316 children 5 to 11 years of age were screened for inclusion, and 2,285 underwent randomization across 81 sites in the United States, Spain, Finland, and Poland. 1,517 children were randomly assigned to receive the Pfizer vaccine and 751 were assigned to receive placebo.

Adverse reactions were generally mild to moderate, lasting 1 to 2 days. Injection-site pain was the most common local reaction, occurring in about 74% of vaccine recipients. Fatigue and headache were the most frequently reported systemic reactions. Frequency of fatigue and headache was similar among vaccine and placebo recipients after the first dose. Fatigue and headache were more frequent among vaccine recipients than among placebo recipients after the second dose.

A significant immunological response was achieved by 99.2% of participants 1 month after the second dose (same immunological response rate as in vaccine recipients 16 to 25 years of age). There were 3 cases of COVID-19 (with onset 7 days or more after the second dose) among vaccine recipients and 16 among placebo recipients; the observed vaccine efficacy was 90.7% (95% CI, 67.7 to 98.3). No cases of severe COVID-19 or multisystem inflammatory syndrome were reported.

link: Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age | NEJM

                                                          


  October 28, 2021

Myocarditis after  BNT162b2 mRNA COVID-19 vaccine in Israel

The Israeli data on myocarditis after vaccination for COVID-19 was published in the New England Journal of Medicine on October 6, 2021. The study retrospectively reviewed data obtained from December 20, 2020 to May 31, 2021, regarding all cases of myocarditis reported to the Israeli Ministry of Health active surveillance system. By May 31, 2021, approximately 5.1 million Israelis (of 9.3 million Israeli residents) had received two doses of the COVID-19 BNT162b2 mRNA vaccine.

There were 283 cases of myocarditis reported. These cases included 142 among vaccinated persons within 21 days after the first dose or 30 days after the second dose, 40 among vaccinated persons not in proximity to vaccination, and 101 among unvaccinated persons. Of the 142 cases occurring after vaccination, the clinical presentation was judged to be mild in 95%; one fulminant case was fatal. Of 136 persons with definite or probable myocarditis, 19 presented after the first dose of vaccine and 117 after the second dose. 

Comparison of the incidence of myocarditis between vaccinated and unvaccinated persons was 2.35 (95% CI, 1.10 to 5.02). This result was driven mainly by the findings for males in younger age groups. The rate ratio was highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.

As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20).

The authors concluded that the incidence of myocarditis was low but increased particularly after the receipt of the second dose of the Pfizer vaccine among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

link: Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel | NEJM

                             


  October 13, 2021

Residual symptoms seven months after COVID-19 in people treated as outpatients

Symptomatic people who tested positive for COVID-19 at the Geneva University Hospitals in Switzerland from March 18 to May 15, 2020, were contacted again at 30 to 45 days and 7 to 9 months from diagnosis and asked about symptoms consistent with COVID-19. This study was published in the Annals of Internal Medicine in September 2021. The follow-up at 7 to 9 months after COVID-19 diagnosis was completed by 410 patients, of whom 39.0% reported residual symptoms. Fatigue (20.7%) was the most common symptom reported, followed by loss of taste or smell (16.8%), shortness of breath (11.7%), and headache (10.0%). The authors concluded that about a third of persons with mild to moderate, acute COVID-19 in an outpatient setting have long-term symptoms at 7 to 9 months.

link: https://www.acpjournals.org/doi/10.7326/M21-0878

                            


  September 27, 2021

Efficacy of the BNT162b2 mRNA Vaccine Booster in Israel

The recent approval in the US of a third (booster) dose of the BNT162b2 messenger RNA vaccine (Pfizer–BioNTech) was based in part on the experience in Israel. In Israel, the administration of a third (booster) dose of the Pfizer vaccine was approved on July 30, 2021, for persons who were 60 years of age or older and who had received a second dose of vaccine at least 5 months earlier. A study published in the New England Journal of Medicine on September 15, 2021, reported on data collected from July 30 through August 31, 2021, regarding 1,137,804 Israeli residents who were 60 years of age or older and had been fully vaccinated (received two doses of the Pfizer vaccine) at least 5 months earlier. The rate of confirmed COVID-19 and the rate of severe illness were compared between those who had received a booster injection at least 12 days earlier and those who had not received a booster injection. The results showed that at least 12 days after the booster dose, the rate of confirmed infection was lower in the booster group than in the non-booster group by a factor of 11.3, and the rate of severe illness was lower by a factor of 19.5. The study concluded that the rates of confirmed COVID-19 and severe illness were substantially lower among those who received a booster (third) dose of the Pfizer vaccine.

link: Protection of BNT162b2 Vaccine Booster against Covid-19 in Israel | NEJM

  
 

COVID-19 Resources Home Page


April 8, 2020

COVID-19 vaccine candidate shows promise, research shows

Interesting news from a story published in ScienceDaily

 

Scientists at the University of Pittsburgh School of Medicine announced a potential vaccine against COVID-19. The vaccine when tested in mice produced antibodies specific to Sars-CoV-2 at quantities sufficient for neutralizing the virus. The paper detailing the research appeared April 2, 2020 in EBioMedicine, which is published by Lancet. Using groundwork laid during earlier coronavirus epidemics, the vaccine targets the spike protein of the coronavirus. The vaccine is produced using lab-made pieces of viral protein to build immunity. It's the same way the current flu shots work. Researchers use a novel approach to deliver the drug, called a microneedle array, to increase potency. The co-senior author of the study stated that "testing in patients would typically require at least a year and probably longer."

link to the study: https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(20)30118-3/fulltext#coronavirus-linkback-header

link to the news article: https://www.sciencedaily.com/releases/2020/04/200402144508.htm

                                                              

  May 19, 2020

 COVID-19: Transmission explained

In a recent blog post, "The Risks-Know Them-Avoid Them," Erin S. Bromage, PhD, Associate Professor of Biology at the University of Massachusetts Dartmouth, explains the science of a contagious dose, where and how the virus spreads, and which environments are the riskiest.  Dr. Bromage does an excellent job of translating data and findings into prose that non-scientists can more readily understand. Hopefully, a better understanding of how the COVID-19 virus spreads will help individuals make decisions about how to avoid becoming infected with the virus.

link to the blog post: https://www.erinbromage.com/post/the-risks-know-them-avoid-them


April 8, 2020

COVID-19 vaccine candidate shows promise, research shows

Interesting news from a story published in ScienceDaily

 

Scientists at the University of Pittsburgh School of Medicine announced a potential vaccine against COVID-19. The vaccine when tested in mice produced antibodies specific to Sars-CoV-2 at quantities sufficient for neutralizing the virus. The paper detailing the research appeared April 2, 2020 in EBioMedicine, which is published by Lancet. Using groundwork laid during earlier coronavirus epidemics, the vaccine targets the spike protein of the coronavirus. The vaccine is produced using lab-made pieces of viral protein to build immunity. It's the same way the current flu shots work. Researchers use a novel approach to deliver the drug, called a microneedle array, to increase potency. The co-senior author of the study stated that "testing in patients would typically require at least a year and probably longer."

link to the study: https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(20)30118-3/fulltext#coronavirus-linkback-header

link to the news article: https://www.sciencedaily.com/releases/2020/04/200402144508.htm



 

April 10, 2020

 Can smart phone apps help beat pandemics?

 An interesting article was posted April 9, 2020 by Dr, Francis Collins, Director of the National Institutes of Health (NIH). On the NIH Director's Blog, he discusses enlisting the use of smart phones for contact tracing and notification in fighting the COVID-19 pandemic. Traditional methods involving teams of public health workers speaking to people via phone or in face-to-face meetings is very time consuming. Lost time allows for infection to spread more widely because there is a delay in finding and notifying individuals exposed to the virus. By taking advantage of smart phones' wireless Bluetooth technology, digital tracing can improve the chances of keeping COVID-19 under control. In China, research showed a correlation between the use of contact-tracing apps and what appears to be sustained suppression of COVID-19 infection. Dr. Collins touches on major ethical, legal, and social issues.

link to the blog post: https://directorsblog.nih.gov/author/collinsfs/


 

  May 29, 2020

 No benefit of hydroxychloroquine or chloroquine alone or with macrolides in large multinational retrospective database study

A large, multinational study that analyzed the hospital outcomes for patients with COVID-19 treated with chloroquine or hydroxychloroquine alone or in combination with macrolides was published in the journal Lancet on May 22, 2020. A multinational registry comprising data from 671 hospitals on six continents was was analyzed. Data included patients hospitalized between December 20, 2019 and April 14, 2020, with a positive laboratory finding of SARS-CoV-2. The registry yielded the data from 96,032 patients for inclusion in the study; 14,888 patients received one of the treatments of interest within 48 hours of diagnosis and 81,114 patients were in the control group who did not receive chloroquine or hydroxychloroquine alone or in combination with macrolides. Outcomes yielded no evidence confirming benefit of hydroxychloroquine or chloroquine when used alone or with a macrolide in terms of in-hospital outcomes for COVID-19. The study showed an association of each of these drug regimens with reduced in-hospital survival and increased frequency of ventricular arrhythmias when compared to the control group. Due to the retrospective observational study design, the possibility of unmeasured confounding factors cannot be excluded. One such possibility is that clinicians treated sicker patients with the drugs. The authors concluded that "randomized clinical trials will be required before any conclusion can be reached regarding benefit or harm of these agents in COVID-19 patients." The authors also stated that "these findings suggest that these drug regimens should not be used outside of clinical trials."

link to the study: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext?rss=yes

  April 23, 2020

 Proposed national COVID-19 testing action plan

The Rockefeller Foundation has provided a comprehensive plan (dated 4/21/2020-see link below) to reopen workplaces and communities based on testing for COVID-19 and close follow-up of positive test results. The goal of the plan is to build a state-led national program of COVID-19 testing that supports reopening the economy through the goals of workforce monitoring, early detection of recurrent outbreaks, and diagnostic and home testing. The plan has 3 major components:

  • Dramatically expand COVID-19 testing from the current 1 million tests per week to 3 million per week over the next 8 weeks and then to 30 million tests per week over the next 6 months. This will require investing in and bolstering test capacity at national, university, and thousands of small local labs across the country.
  • Train and launch an army of healthcare workers to administer the tests and to do contact tracing for those with positive tests.They suggest this be organized around the state public health departments. They propose hiring 100,000 to 300,000 workers who will need to be supported by computer networks linked to many electronic health records.
  • Integrate and expand federal, state, and private data platforms to facilitate real-time analyses and disease tracing. This will identify recurrent COVID-19 outbreaks and direct surges in testing volumes and follow-up.

This white-paper provided by the Rockefeller Foundation has many good ideas and is a must read. The massive plan will require integration of many scattered computerized data platforms. All this will need to balance privacy with the need for infection control.

link to the plan: https://www.rockefellerfoundation.org/wp-content/uploads/2020/04/TheRockefellerFoundation_WhitePaper_Covid19_4_21_2020.pdf


 

April 10, 2020

 Can smart phone apps help beat pandemics?

 An interesting article was posted April 9, 2020 by Dr, Francis Collins, Director of the National Institutes of Health (NIH). On the NIH Director's Blog, he discusses enlisting the use of smart phones for contact tracing and notification in fighting the COVID-19 pandemic. Traditional methods involving teams of public health workers speaking to people via phone or in face-to-face meetings is very time consuming. Lost time allows for infection to spread more widely because there is a delay in finding and notifying individuals exposed to the virus. By taking advantage of smart phones' wireless Bluetooth technology, digital tracing can improve the chances of keeping COVID-19 under control. In China, research showed a correlation between the use of contact-tracing apps and what appears to be sustained suppression of COVID-19 infection. Dr. Collins touches on major ethical, legal, and social issues.

link to the blog post: https://directorsblog.nih.gov/author/collinsfs/


 

April 10, 2020

 Can smart phone apps help beat pandemics?

 An interesting article was posted April 9, 2020 by Dr, Francis Collins, Director of the National Institutes of Health (NIH). On the NIH Director's Blog, he discusses enlisting the use of smart phones for contact tracing and notification in fighting the COVID-19 pandemic. Traditional methods involving teams of public health workers speaking to people via phone or in face-to-face meetings is very time consuming. Lost time allows for infection to spread more widely because there is a delay in finding and notifying individuals exposed to the virus. By taking advantage of smart phones' wireless Bluetooth technology, digital tracing can improve the chances of keeping COVID-19 under control. In China, research showed a correlation between the use of contact-tracing apps and what appears to be sustained suppression of COVID-19 infection. Dr. Collins touches on major ethical, legal, and social issues.

link to the blog post: https://directorsblog.nih.gov/author/collinsfs/


 

April 10, 2020

 Can smart phone apps help beat pandemics?

 An interesting article was posted April 9, 2020 by Dr, Francis Collins, Director of the National Institutes of Health (NIH). On the NIH Director's Blog, he discusses enlisting the use of smart phones for contact tracing and notification in fighting the COVID-19 pandemic. Traditional methods involving teams of public health workers speaking to people via phone or in face-to-face meetings is very time consuming. Lost time allows for infection to spread more widely because there is a delay in finding and notifying individuals exposed to the virus. By taking advantage of smart phones' wireless Bluetooth technology, digital tracing can improve the chances of keeping COVID-19 under control. In China, research showed a correlation between the use of contact-tracing apps and what appears to be sustained suppression of COVID-19 infection. Dr. Collins touches on major ethical, legal, and social issues.

link to the blog post: https://directorsblog.nih.gov/author/collinsfs/


 

April 10, 2020

 Can smart phone apps help beat pandemics?

 An interesting article was posted April 9, 2020 by Dr, Francis Collins, Director of the National Institutes of Health (NIH). On the NIH Director's Blog, he discusses enlisting the use of smart phones for contact tracing and notification in fighting the COVID-19 pandemic. Traditional methods involving teams of public health workers speaking to people via phone or in face-to-face meetings is very time consuming. Lost time allows for infection to spread more widely because there is a delay in finding and notifying individuals exposed to the virus. By taking advantage of smart phones' wireless Bluetooth technology, digital tracing can improve the chances of keeping COVID-19 under control. In China, research showed a correlation between the use of contact-tracing apps and what appears to be sustained suppression of COVID-19 infection. Dr. Collins touches on major ethical, legal, and social issues.

link to the blog post: https://directorsblog.nih.gov/author/collinsfs/



  April 21, 2020

 28,000 missing deaths: tracking the true toll of the coronavirus crisis

A review of mortality data in 11 countries showing that far more people died in these countries than in previous years was reported by Jin Wu and Allison McCann in the New York Times on April 21, 2020. They estimated the excess mortality for each country by comparing the number of people who died from all causes this year with the historical average during the same period. The finding was that at least 28,000 more people have died during the coronavirus pandemic over the last month than the official COVID-19 death counts report. Since most countries report only those COVID-19 deaths that occur in hospitals there are many COVID-19 deaths that are unreported. The 28,000 excess deaths found in this study include deaths from COVID-19 as well as those from other causes, likely including people with other disorders who were not treated as hospitals became overwhelmed. This article suggests that the overall global death toll from COVID-19 will be much higher than the reports of deaths due to COVID-19 confirmed by testing. For impressive graphic presentation of these trends in each country please use the following link to the article.

link to the news article: https://www.nytimes.com/interactive/2020/04/21/world/coronavirus-missing-deaths.html?smid=em-share

 


  April 21, 2020

 28,000 missing deaths: tracking the true toll of the coronavirus crisis

A review of mortality data in 11 countries showing that far more people died in these countries than in previous years was reported by Jin Wu and Allison McCann in the New York Times on April 21, 2020. They estimated the excess mortality for each country by comparing the number of people who died from all causes this year with the historical average during the same period. The finding was that at least 28,000 more people have died during the coronavirus pandemic over the last month than the official COVID-19 death counts report. Since most countries report only those COVID-19 deaths that occur in hospitals there are many COVID-19 deaths that are unreported. The 28,000 excess deaths found in this study include deaths from COVID-19 as well as those from other causes, likely including people with other disorders who were not treated as hospitals became overwhelmed. This article suggests that the overall global death toll from COVID-19 will be much higher than the reports of deaths due to COVID-19 confirmed by testing. For impressive graphic presentation of these trends in each country please use the following link to the article.

link to the news article: https://www.nytimes.com/interactive/2020/04/21/world/coronavirus-missing-deaths.html?smid=em-share

 


                                                                                                                                             

  June 1, 2020

 In New York City, household size may be a more important determinant of COVID-19 infection rate than population density

Throughout the United States and even within the same city, the number of confirmed COVID-19 cases relative to population size has varied greatly. It is important to know which factors drive this variation because this has important policy implications on how to contain the epidemic. A statistical study (published in preprint in medRxiv on May 20, 2020; not yet peer reviewed) of this variation across New York City used available data to investigate these factors by ZIP code.The study found that when taking into account important factors such as population density, average household size, percentage of population below poverty line, and percentage above age 65, it was average household size that emerged as the most important variable correlating with rate of confirmed cases. The percentage of population above age 65 as well as the population below the poverty line were additional indicators that impacted the case incidence rate. Interestingly, contrary to common belief, population density itself did not have a significant impact on the case rate in a given ZIP code. In fact, when the other factors were taken into account, the study found that population density and case incidence were negatively correlated. However, the study used 2018 statistical data that did not take into account any changes in population during the outbreak. It also was not clear how nursing homes and their residents were classified for the purposes of this study, which could have affected study results.

link to the study: https://www.medrxiv.org/content/10.1101/2020.05.25.20112797v1.full.pdf+html

 

  May 18, 2020

 Promising COVID-19 vaccine using inactivated virus 

Purified inactivated viruses have been traditionally used in vaccine development, providing safe and effective vaccines to prevent diseases caused by viruses such as poliovirus and influenza virus. In a paper published in Science on May 6, 2020, a group of researchers in China reported on a purified, inactivated SARS-CoV-2 vaccine (PiCoVacc) that produced neutralizing antibodies in mice, rats, and non-human primates. Antibodies were shown to neutralize 10 representative strains of the virus. When later infected with SARS-CoV-2, the rhesus macaques (a non-human primate species that shows a COVID-19–like disease caused by SARS-CoV-2 infection) who received a 6-microgram dose showed complete protection. The vaccine did not elicit any observable or biochemical adverse effects. Notably, there was no evidence of a phenomenon known as antibody-dependent infection enhancement, which previous reports have raised as a concern.

The authors said, "These results suggest a path forward for clinical development of SARS-CoV-2 vaccines for use in humans." Clinical trials with PiCoVacc are expected to begin later this year.

link to the study :https://science.sciencemag.org/content/early/2020/05/06/science.abc1932


  April 21, 2020

 28,000 missing deaths: tracking the true toll of the coronavirus crisis

A review of mortality data in 11 countries showing that far more people died in these countries than in previous years was reported by Jin Wu and Allison McCann in the New York Times on April 21, 2020. They estimated the excess mortality for each country by comparing the number of people who died from all causes this year with the historical average during the same period. The finding was that at least 28,000 more people have died during the coronavirus pandemic over the last month than the official COVID-19 death counts report. Since most countries report only those COVID-19 deaths that occur in hospitals there are many COVID-19 deaths that are unreported. The 28,000 excess deaths found in this study include deaths from COVID-19 as well as those from other causes, likely including people with other disorders who were not treated as hospitals became overwhelmed. This article suggests that the overall global death toll from COVID-19 will be much higher than the reports of deaths due to COVID-19 confirmed by testing. For impressive graphic presentation of these trends in each country please use the following link to the article.

link to the news article: https://www.nytimes.com/interactive/2020/04/21/world/coronavirus-missing-deaths.html?smid=em-share