No Excess Deaths, In Spite of COVID?

 More than a year since the outbreak of COVID-19 in the United States, a researcher finds the 2019 death toll was in line with those of recent years and did not reflect an overall increase in mortality. Genevieve Briand, Ph.D., an assistant program director and senior lecturer at Johns Hopkins University, provides this analysis in a not-yet-published paper provided to Health Care News.

 According to Briand, the objective of her paper is “to assess whether the total death number the U.S. experienced during the 2020 calendar year (2019-20 seasonal year) was unexpected or alarming.” There has been wide speculation that COVID-19 caused nearly 300,000 excess deaths in 2020. 

Briand says the mortality rate shows that is not true. Death Rates vs. Totals The Morbidity and Mortality Weekly Report by the National Center for Health Statistics (NCHS) reports deaths as a rate, or proportion of the population, instead of just the total number of deaths. Using rates accounts for changes in population from one year to the next, which, in the case of the United States, invariably means increases in population. U.S. death rates have been between 0.8 percent and 0.9 percent of the total population each year from 1999 to 2019, Briand notes.

 “A difference of 0.1 percent in the death rate of one year over another has been observed and is to be expected,” Briand writes. The U.S. death rate for 2020 was 1.0 percent, up 0.1 percent from 2019.

 “The death rates show that the total deaths increase in 2020 was not unexpected or alarming, but rather is explained by the population increase,” Briand writes. “This result, in conjunction with the facts that (1) every recorded death is allocated to one cause, (2) a new cause was specially created for COVID-19, and (3) means to test and record COVID-19 deaths were considerably expanded, points to suspicions that some reclassification between the cause of death and COVID-19 deaths might have occurred.” 

CDC-Infected Data 

In saying “a new cause was specially created for COVID-19,” Briand is referring to a little-noticed but far-reaching step undertaken by the CDC [Centers for Disease Control and Prevention] in the first weeks of the pandemic. 

On March 24, 2020, the CDC issued guidance to all coroners, medical examiners, and physicians that unilaterally altered the 17-year-old process by which it calculated disease-caused deaths, creating a special classification for tabulating COVID-19 deaths. 

The CDC’s action was in response to a change in World Health Organization (WHO) Emergency Use ICD (International Classification of Diseases) Codes for the COVID-19 Outbreak. As noted in a recent peer-reviewed study by the Institute for Pure and Applied Knowledge, substantially altering how death is recorded exclusively for COVID-19 means “the CDC compromised the quality, objectivity, and integrity of all COVID-19 data collected to date.” 

Although not prepared to go that far with her criticism, Briand does raise questions about the CDC’s reclassification of COVID-19 deaths.

 “[I]t is not assumed, or even suggested, that such reclassifications if they occurred, were maliciously intended to inflate COVID-19 numbers,” Briand writes. “Nonetheless, individuals within organizations tend to respond to financial incentives and groupthink to some extent. Similarly, it is not assumed or even suggested that mitigation measures adopted were designed to harm targeted groups in the U.S. population. Nonetheless, the unequal toll those measures have had on individuals across our society cannot be ignored.” 

No Excess Deaths 

On October 20, 2020, the CDC published estimates from the NCHS showing 299,000 excess deaths from late January to October 3, 2020, with twothirds attributed to COVID-19. 

A study by L. M. Rossen et al. suggested the COVID-19 deaths were underestimated, but “the model they used to produce excess deaths did not account for the increase in population,” Briand said. 

Similarly, a study of “Excess Deaths from COVID-18 and Other Causes in the US, March 1, 2020 to January 2, 2021,” published by jamanetwork.com (April 2), concluded the United States experienced 22.9 percent more deaths than expected in the period under review.

 “The model does not adjust directly for population aging, which could contribute to an overestimate of excess deaths,” jamanetwork.com notes. “Other study limitations include reliance on provisional data and modeling assumptions.” 

Briand says the data show the U.S. population did not decrease in the 2020 calendar year. “COVID-19 deaths did not decimate the population,” Briand writes. 

One Size for All 

Briand suggests the response to COVID-19 was overwrought. “The picture of the U.S. COVID-19 situation was heavily skewed by death numbers from jurisdictions such as New York City and the State of New Jersey,” Briand writes. 

“At the state level, many have shown no change in death numbers or pattern of deaths in 2019-20 compared to previous seasons.” Briand asks, “has any consideration ever been given to the relevance to the national picture and national ‘solutions,’ to state, county, local, and individual situations? Or have COVID-19 measures been blindly adopted and applied, top-down, in haste, obsessively, and shortsightedly? What role did groupthink play in this?” 

‘Data Manipulation’ 

“With all the data manipulation, political posturing, and change of definitions, the only reliable statistic is probably all-cause mortality,” says Jane Orient, M.D., the executive director of the American Association of Surgeons and Physicians.

 “Despite many painful deaths from COVID-19—at least 100,000 of which might have been prevented with early treatment, the number and pattern of deaths in most jurisdictions outside of downstate New York were not greatly different from previous years.” 

Briand says she “put data downloaded from publicly available CDC datasets in graphical and tabular form.” 

The data presented in her paper “are not estimates—they are recorded past deaths, maintained and made publicly available by the CDC,” Briand writes. “The data have not been produced, adjusted, nor tampered with, in any way, by the author.”

 Briand’s work has touched a nerve. A JHU newspaper publication took down an article describing a presentation she made on the topic. 

Bonner R. Cohen, Ph.D., (bcohen@ nationalcenter.org) is a senior fellow at the National Center for Public Policy Research. 

https://goodmaninstitute.us4.list-manage.com/track/click?u=4bf70514476d2aaac7c0dada0&id=ac39ad4cbb&e=d9fedbd441

U.S. Bound-Migrants Vaccinated for COVID-19 in Mexican Border City

 More than a thousand migrants who hope to reach the United States were vaccinated against COVID-19 on Thursday through a first-time effort made possible by a private donation of shots from a U.S. company, a shelter director said.

About 1,200 migrants, mainly from Central America, received the Pfizer-BioNTech vaccine in the border city of Tijuana, said Gustavo Banda, director of the Ambassadors of Jesus shelter. He declined to give the name of the donor.

"This is positive, it is the first time it has been done," Banda said. "It was extremely important to vaccinate migrants because we're a long-stay shelter where they can spend many months, even a year."

Reuters consulted several migrant shelters and did not find any other cases of migrants receiving vaccines.

The administration of U.S. President Joe Biden is dealing with a growing humanitarian crisis as more people reach the U.S. border. Authorities in Mexico, the United States and Central America have tightened border restrictions in recent months.

Mexico's government, which has already received doses of AstraZeneca's vaccine from the United States to supplement its vaccine campaign, has said it may ask for U.S. help in vaccinating people along their shared border.

Mexican President Andres Manuel Lopez Obrador and U.S. Vice President Kamala Harris are due to explore ways of tackling undocumented immigration in talks on Friday.

https://www.usnews.com/news/world/articles/2021-05-06/us-bound-migrants-vaccinated-for-covid-19-in-mexican-border-city

Germany Says Production Capacity, Not Patents, Key to Upping Vax Output

 The main challenge to raising production of COVID-19 vaccines is how to quickly and effectively transfer technology, Germany's health minister said Friday, reiterating Berlin's opposition to a U.S. proposal to waive patent protection.

"The main issue is not patent protection but production capacity," Jens Spahn told a news conference on Friday.

In a jab at the Biden administration, Spahn also said: "I would be delighted if the United States shows the same willingness to export vaccines that we in Germany do."

https://www.usnews.com/news/world/articles/2021-05-07/germany-says-production-capacity-not-patents-key-to-upping-vaccine-output

EU executive eyes new Pfizer deal for 1.8B COVID vax doses 'very soon'

 The European Union's executive said on Friday it hoped the bloc would soon be able to finalise a new contract with Pfizer for up to 1.8 billion doses of COVID-19 vaccines to cover booster shots and the inoculation of children in the coming years.

Spokespeople for the European Commission declined to comment on whether France was delaying talks on finalising the deal, as had been reported by German newspaper Die Welt.

"The college of (EU) Commissioners, we're hoping they'll be able to give the green light to the new contract... We hope the College will be able to give the go ahead very soon," a spokesman told a news briefing in EU hub Brussels.

https://news.yahoo.com/eu-executive-eyes-pfizer-deal-103835021.html

CDC reviewing higher COVID death toll from independent group, considers revising official count

 The U.S. Centers for Disease Control and Prevention (CDC) is reviewing an estimate of global COVID-19 deaths from the University of Washington that is more than double the official count to determine if the CDC figures should be revised, CDC Director Rochelle Walensky said at a Friday press briefing.

The analysis by the Institute for Health Metrics and Evaluation pegs the global death toll at nearly 6.9 million and the U.S. count at more than 900,000. The CDC on Wednesday put its latest official estimate at 575,491 deaths in the United States due to the novel coronavirus.

Other CDC numbers have also pointed to a higher overall death count from the pandemic. The CDC has estimated there were as many as 162,400 more deaths than expected during the pandemic through Feb. 27, 2021, excluding the deaths it has attributed directly to COVID-19.

Deaths go unreported as most countries only record those that occur in hospitals or of patients with a confirmed infection, the report showed.

IHME estimated total COVID-19 deaths by comparing anticipated deaths from all causes based on pre-pandemic trends with the actual number of all deaths during the pandemic.

The IHME is an independent health research organization that provides comparable measurement of the world's health problems. It has been cited in the past by the White House and its reports are watched closely by public health officials.

White House COVID-19 adviser Andy Slavitt said at the Friday briefing the United States expects to release around 10 million doses of AstraZeneca PLC's COVID-19 shot in the coming weeks pending U.S. regulatory authorization, reiterating previous White House guidance.

The U.S. government has been under mounting pressure in recent weeks to provide surplus vaccines to other nations desperately in need as it makes swift progress vaccinating its own residents. Many countries where the virus is still rampant are struggling to acquire vaccine supplies to help tame the pandemic. 

https://finance.yahoo.com/news/1-cdc-reviewing-higher-covid-163257164.html

Brazilian Firm to Produce Russian Vaccine Without Regulatory Approval

 The Brazilian pharmaceutical company that plans to produce Russia's Sputnik V coronavirus vaccine will start making it next week even before health regulator Anvisa gives approval for use in Brazil, the company's chief executive said on Friday.

União Quimica's facility in São Paulo has been certified by Anvisa for good production practices and the vaccine will be made for export to countries that have approved it, said CEO and founder Fernando Marques.

"We intend to start production next week with a view to export," Marques said. He said Sputnik V will not be used in Brazil until it is approved, but neighboring Latin American countries have approved the vaccine and want deliveries.

Anvisa last week held off approving imports of Sputnik V sought by Brazilian state governors amid a second wave of the virus that has killed more than 415,000 Brazilians.

In a setback for the Russian vaccine, the regulator's technical staff warned of "flaws" in the development and clinical testing of Sputnik, said the data presented on the vaccine's safety and efficacy was incomplete.

Marques on Friday told a Senate commission on COVID-19 that União Quimica expects to receive a batch of active ingredient from Moscow next week to start making the vaccine for export at its plant near São Paulo's Guarulhos airport.

"So, the situation today is this: we will start production, obviously when we receive the active ingredient, and we will wait for the registration to make the local production available for use in Brazil," he told senators.

The Russian Direct Investment Fund that is marketing Sputnik V developed by Russia's Gamaleya Research Institute has plans to supply the vaccine to Latin American countries from Brazil.

https://www.usnews.com/news/world/articles/2021-05-07/brazilian-firm-to-produce-russian-vaccine-without-regulatory-approval

WHO gives emergency nod to China's Sinopharm vaccine

 The World Health Organisation (WHO) approved a Covid-19 vaccine from China's state-owned drugmaker Sinopharm for emergency use yesterday, a boost to Beijing's push for a big role in inoculating the world.

The vaccine, one of two main Chinese coronavirus vaccines that have been given to hundreds of millions of people in China and elsewhere, is the first developed by a non-Western country to win WHO backing.
It is also the first time the WHO has given emergency use approval to a Chinese vaccine for any infectious disease.
Earlier this week, separate WHO experts had expressed concern about the quality of data the company provided on side effects.
A WHO emergency listing is a signal to national regulators that a product is safe and effective.
It also allows it to be included in Covax, a global programme to provide vaccines mainly for poor countries, which has hit supply problems.
'This expands the list of Covid-19 vaccines that Covax can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine, WHO Director-General Tedros Adhanom Ghebreyesus told a briefing.
Senior WHO adviser Bruce Aylward said it would be up to Sinopharm to say how many doses of its vaccine it can provide to the programme, but added: 'They are looking at trying to provide substantial support, make substantial doses available while at the same time of course trying to serve China's population.
The WHO had already given emergency approval to Covid-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson and, last week, Moderna.
The decision to approve Sinopharm's vaccine was taken by WHO's technical advisory group, which began meeting on April 26 to review the latest clinical data as well as Sinopharm's manufacturing practices.
'Its easy storage requirements make it highly suitable for low-resource settings, a WHO statement said. Tedros said that, following the approval, its separate Strategic Advisory Group of Experts (SAGE) had recommended that adults over 18 receive two doses of the Sinopharm vaccine.
'On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks, the WHO statement said.
The vaccine, developed by Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group, has an estimated efficacy of 79% for all age groups, it said.
However, it added: 'Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group.
The WHO has said it could reach a decision on China's other main Covid-19 vaccine, made by Sinovac Biotech, next week. The technical experts reviewed it on Wednesday.
Didier Laurent, chair of WHO's technical advisory group, told the press conference: 'We have started to review the report from Sinovac.
We actually requested additional information to the manufacturer...which we hope to receive very soon to make a decision.
China has deployed around 65mn doses of the Sinopharm vaccine and more than 200mn doses of the Sinovac shot.
Both have been exported to many countries, particularly in Latin America, Asia and Africa, many of which have had difficulty securing supplies of vaccines developed in the West.

https://menafn.com/1102047216/WHO-gives-emergency-nod-to-Chinas-Sinopharm-vaccine