Coronavirus Breaking News

The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.

Sep 16, 2021 • 4:09 pm CDT

Pfizer Canada ULC and BioNTech SE announced that Health Canada had granted Approval for COMIRNATY® to prevent COVID-19 in individuals 12 years of age and older.

The vaccine was initially authorized for use in Canada under an Interim Order Authorization on December 9, 2020, and has been referred to as the Pfizer-BioNTech COVID-19 Vaccine.

The formulation for Pfizer-BioNTech COVID-19 Vaccine is the same formulation as COMIRNATY, and they are considered interchangeable by Health Canada.

“Based on the longer-term follow-up data that we submitted, today’s decision by Health Canada affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” said Fabien Paquette, Vaccines Lead, Pfizer Canada, in a press statement issued on September 16, 2021.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, was developed by BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in Canada, the United States, the European Union, and the United Kingdom, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies.

Sep 14, 2021 • 4:52 pm CDT

According to a new study published by Stanford Medicine today in the journal Nature Communications, hospitalized COVID-19 patients are substantially more likely to have autoantibodies — antibodies directed at their own tissues or substances their immune cells secrete into the blood — than people without COVID-19.

“If you get sick enough from COVID-19 to end up in the hospital, you may not be out of the woods even after you recover,” stated PJ Utz, M.D., professor of immunology and rheumatology at Stanford Medicine, in a press release issued on September 14, 2021.

The researchers identified and measured levels of antibodies targeting the SARS-C0V-2 coronavirus, autoantibodies, and antibodies directed against cytokines, proteins that immune cells secrete to communicate with one another and coordinate their overall strategy. 

The scientists found that upward of 60% of all hospitalized COVID-19 patients, compared with about 15% of healthy controls, carried anti-cytokine antibodies.

This could be the result of immune-system overdrive triggered by a virulent, lingering infection. In the fog of war, 'the abundance of cytokines may trip off the erroneous production of antibodies targeting them,' said Utz, a member of Stanford Bio-X, the Stanford Institute for Immunity, Transplantation, and Infection, and the Stanford Maternal and Child Health Research Institute.

If any of these antibodies block a cytokine’s ability to bind to its appropriate receptor, the intended recipient immune cell may not get activated. That, in turn, might buy the coronavirus more time to replicate and lead to a much worse outcome.

“Within a week after checking in at the hospital, about 20% of these patients had developed new antibodies to their own issues that weren’t there the day they were admitted,” Utz said. “In many cases, these autoantibody levels were similar to what you’d see in a diagnosed autoimmune disease.”

In some cases, the presence of those newly detected autoantibodies may reflect an increase, driven by the immune response, of antibodies that had been flying under the radar at low levels, Utz said. It could be that inflammatory shock to the systems of patients with severe COVID-19 caused a jump in previously undetectable, and perhaps harmless, levels of autoantibodies these individuals may have been carrying before infection. 

In other cases, autoantibody generation could result from exposure to viral materials that resemble our own proteins, Utz said.

“It’s possible that in the course of a poorly controlled SARS-CoV-2 infection — in which the virus hangs around for too long while an intensifying immune response continues to break viral particles into pieces — the immune system sees bits and pieces of the virus that it hadn’t previously seen,” he said.

“If any of these viral pieces too closely resemble one of our own proteins, this could trigger autoantibody production.”

The finding bolsters the argument for vaccination, he added.

Vaccines for COVID-19 contain only a single protein — SARS-CoV-2’s so-called spike protein — or the genetic instructions for producing it. Thus, with vaccination, the immune system is never exposed to — and potentially confused by the numerous other novel viral proteins generated during infection.

In addition, vaccination is less intensely inflammatory than an actual infection, Utz said, so there’s less likelihood that the immune system would be confused into generating antibodies to its own signaling proteins or to the body’s own tissues.

“Patients who, in response to vaccination, quickly mount appropriate antibody responses to the viral spike protein should be less likely to develop autoantibodies,” he said.

Indeed, a recent study in Nature to which Utz contributed showed that, unlike SARS-CoV-2 infection, the Cominraty COVID-19 vaccine produced by Pfizer-BioNTech doesn’t trigger any detectable generation of autoantibodies among recipients.

“If you haven’t been vaccinated and are telling yourself, ‘Most people who get COVID get over it and are OK,’ remember that you can’t know in advance that when you get COVID-19, it will be a mild case,” Utz said. 

“If you do get a bad case, you could be setting yourself up for a lifetime of trouble because the virus may trip off autoimmunity."

"We can’t say yet that you’ll definitely get an autoimmune disease — we haven’t studied any patients long enough to know whether these autoantibodies are still there a year or two later, although we hope to study this — but you certainly might. So I wouldn’t want to take that chance.”

Utz intends to study blood samples from SARS-CoV-2-infected people who are asymptomatic or who’ve had mild COVID-19 symptoms. That could help determine whether the massive hyperactivation of the immune system, which doesn’t occur in mildly symptomatic or asymptomatic people, is what causes trouble or whether the mere molecular resemblance of SARS-CoV-2 proteins is enough to trigger autoantibody generation.

Note: Various other Stanford researchers participated in this study. And researchers at the University of Pennsylvania, Philipps Marburg University, the University of Tennessee, Oklahoma Medical Research Foundation, and Kaiser Permanente Northern California contributed to the work.

The study was supported by the National Institutes of Health and numerous other funders. For more news about the school, please visit http://med.stanford.edu/school.html. 

Sep 13, 2021 • 10:52 am CDT

The U.S. FDA announced on September 10, 2021, 'Parents need to remember that the COVID-19 vaccines currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older—different dosing regimens are being investigated.'

'It is important for the clinical trials to be completed before vaccinating young kids,' stated Janet Woodcock, M.D., Acting Commissioner, and Peter Marks, M.D., Ph.D., Director, with the FDA.

The FDA confirmed it would take the following steps to ensure the safety and efficacy of COVID-19 related products for children:

  • First, vaccine manufacturers have reported that the necessary clinical trials involving children as participants are currently underway. Some have stated that they are still enrolling, and some are still administering doses or following participants. This process is expected to include a follow-up period of at least two months to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients.
  • Once the manufacturers complete the relevant portion of their clinical trials, they have to analyze the data from the studies to understand how safe the vaccine is and how well it works in the clinical trial participants. The FDA will work closely with each manufacturer to ensure this data analysis is robust and meets regulatory standards. After manufacturers analyze their clinical trial data, they will compile the information and may request an emergency use authorization (EUA) or submit for approval a biologics license application (BLA), as appropriate, for this young population to the FDA. 
  • When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly, and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months. However, the agency’s ability to rapidly review these submissions will depend partly on the quality and timeliness of the submissions by manufacturers.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. 

Sep 12, 2021 • 6:26 pm CDT

Northwest Michigan-based Spectrum Health announced on September 9, 2021, it will grant temporary exemptions from its employee vaccine mandate to individuals who can prove they have naturally acquired immunity to COVID-19.

The Detroit News reported will grant an exemption to those who have a positive PCR or antigen test for COVID-19 plus a positive antibody test from within the past three months.

"While we still recommend vaccination for people with prior COVID-19 infection. However, according to this new research, there is increasing evidence that natural infection affords protection from COVID-19 reinfection and severe symptoms for a period of time," the Spectrum statement said.

Immunity to a SARS-CoV-2 coronavirus infection can be obtained in various ways discussed on this web page.

Sep 10, 2021 • 12:44 pm CDT

The U.S. CDC confirmed on September 10, 2021, although most people with COVID-19 get better within the weeks following illness, some people experience post COVID-19 conditions.

A recent CDC study shows that adults with COVID-19 may experience ongoing health problems that can last four or more weeks after SARS-CoV-2 betacoronavirus infection.

These health problems may include shortness of breath, fatigue, difficulty concentrating (“brain fog”), headache, fast-beating or pounding heart, cough, joint or muscle pain, dizziness/lightheadedness, or mood changes, among other symptoms.

Even people who did not have significant COVID-19 symptoms days or weeks after they were infected can have post-COVID conditions.

The best way to prevent post-COVID conditions is by getting vaccinated against COVID-19 as soon as you can, says the CDC.

Furthermore, the COVID-19 vaccines recommended for use in the USA continue to offer protection against severe illness, hospitalization, and death.

To find a vaccine provider near you, visit Vaccines.gov or a local pharmacy.

Sep 9, 2021 • 5:14 pm CDT

Warning that COVID-19 represents a serious risk for pregnant women in Latin America and the Caribbean, Pan American Health Organization (PAHO) Director Carissa F. Etienne urged countries to prioritize expectant and lactating mothers for vaccination.

“We know that if pregnant women get sick.... they have a risk of developing serious COVID symptoms,” she said during her weekly PAHO press briefing on September 8, 2021.

More than 270,000 pregnant women have become sick with COVID in the Americas during the pandemic, and more than 2,600 have died from the COVID-19 since early 2020, says the PAHO.

Furthermore, the U.S. CDC reported (155) pregnant women (vaccination status undisclosed) have died from COVID-19 during the pandemic through September 13, 2021.

The problem is particularly acute in Mexico, Argentina, and Brazil, which account for about half of all COVID deaths among pregnant women in the PAHO.

While new infections are declining in the Caribbean, COVID-19-related deaths are increasing on many islands, including Sint Marteen, Jamaica, Puerto Rico, and COVID-19 infections are rising in Costa Rica, Guatemala, and Belize. 

“The PAHO recommends that all pregnant women, after their first trimester as well as women who are breastfeeding, receive a COVID-19 vaccine," added Etienne.

Dr. Etienne reported about 28% of people in Latin America and the Caribbean have been fully vaccinated.

The Centers for Disease Control and Prevention (CDC) and the European Medicines Agency say 'COVID-19 vaccination is recommended for all 12 years and older women, including pregnant women, breastfeeding, trying to get pregnant, or might become pregnant in the future.

As of September 9, 2021, just twenty-nine countries worldwide do not recommend pregnant women receive a COVID-19 vaccine, according to the COVID-19 Maternal Immunization Tracker, produced by Johns Hopkins University.

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Sep 9, 2021 • 3:08 pm CDT

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced its Authorization for a third booster dose of a COVID-19 vaccine today.

In a press release issued on September 9, 2021, Dr. June Raine, MHRA Chief Executive, said, 'We are committed to getting safe and effective COVID-19 vaccines to the UK public. This means ensuring that existing COVID-19 vaccines can continue to be used in the most effective way possible.'

'We know that a person’s immunity may decline over time after their first vaccine course.'

'I am pleased to confirm that the COVID-19 vaccines made by Pfizer-BioNTech (Comirnaty) and AstraZeneca (Vaxzevria) can be used as safe and effective booster doses.'

'It will now be for the Joint Committee on Vaccination and Immunisation (JVCI) to advise on whether booster jabs will be given and, if so, which vaccines should be used.'

The JVCI recently published two updates during September 2021:

  • JCVI issued updated advice on September 3, 2021, regarding COVID-19 vaccination of children aged 12 to 15.
  • The JCVI advised on September 1, 2021, that people with severely weakened immune systems should have a third vaccine dose as part of their primary COVID-19 vaccination schedule.

Additionally, the NHRA says the 'current supply of the COVID-19 vaccines made by Pfizer and AstraZeneca has been authorized on an emergency use basis. Both vaccines are also authorized under Conditional Marketing Authorisations (CMAs), but changes to these would follow a different procedure.

Vaccines covered by CMAs can also be used as part of deployment programs via “off-label” use under a prescriber’s direction.

Sep 8, 2021 • 2:48 pm CDT

The European Medicines Agency (EMA), which monitors the safety of COVID-19 vaccines Authorised in the European Union (EU), published updated safety notices on September 8, 2021.

The monthly safety updates give an overview of each Authorized COVID-19 vaccine's safety evaluation.

The COVID-19 vaccines Authorized for use in the EU are as follows:

  • Comirnaty
  • Spikevax (previously COVID-19 Vaccine Moderna)
  • Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
  • COVID-19 Vaccine Janssen

For more information on these reports, see the European Suspected Adverse Drug Reactions database (www.adrreports.eu).

Over 377 million doses of COVID-19 vaccines have been given to people in the EU and European Economic Area as of the end of July 2021.

Located in The Netherlands, the European Medicines Agency is a decentralized agency of the EU responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. The EMA is governed by an independent Management Board.

Sep 8, 2021 • 1:33 pm CDT

Cuba began vaccinating children as young as 2 years of age on September 5, 2021, with a locally developed COVID-19 vaccine not recognized by the World Health Organization, reported Voice of America.

Cuba is administering the Soberana-2 COVID-19 vaccine, which was approved for this age group by local regulators on September 3, 2021.

On June 14, 2021, the first adolescents in the clinical trial were carried out at the Juan Manuel Márquez Pediatric Hospital, the Carlos J. Finlay polyclinic in the Marianao municipality, and the 5 de Septiembre polyclinic in the Playa municipality in the province of Havana. 

All 350 children included in the trial received both doses of SOBERANA-02. In addition, all children in the subgroup 12 to 18 years old have already received the booster dose with SOBERANA-Plus. 

This study's results showed that the SOBERANA-02 vaccine was safe for its administration in children and adolescents.

Based on the Phase I / II trial results in pediatric ages with SOBERANA-02, Cuba's Center for State Control of Medicines, Equipment, and Medical Devices was requested on August 27th to extend emergency use authorization for emergency use a population between 3 and 18 years of age.

Furthermore, the effect of the booster (3rd) vaccine dose with SOBERANA-Plus was summarized only for adolescents in Phase I of the trial. A significant increase in the values ​​was detected after the 3rd vaccine dose with all the immunological variables.

The Soberana 02 vaccine has been in human clinical trials since October 30, 2020. Soberana 02 is produced by the Finlay Vaccine Institute (IFV), a Cuban epidemiological research institute, and the Pasteur Institute of Iran. The IFV was created in 1991.

Sep 6, 2021 • 12:29 pm CDT

According to a Public Health England (PHE) blog written by Julie Yates on August 26, 2021, COVID-19 vaccines might offer unborn children some protection against COVID-19.

Recent research suggests protective antibodies generated in response to COVID-19 vaccination can be passed from mother to newborn during pregnancy and through breastmilk after birth.

There is no current evidence that COVID-19 vaccination while breastfeeding causes any harm to breastfed children or affects the ability to breastfeed. However, according to PHE, additional research is needed to determine how much protection these antibodies offer or how long that protection would last.

Furthermore, there is no current evidence of any serious side effects for vaccinated pregnant women.

And it is still unclear whether the SARS-CoV-2 coronavirus can be transmitted vertically.

Only about 2% of neonates born to COVID-positive mothers in the UK test positive for SARS-CoV-2 in the first 12 hours of life (Vousden et al., 2021).

The UK's Medicines and Healthcare Regulatory Agency (MHRA) thoroughly monitors any suspected side effects involving pregnancy and COVID-19 vaccination.

The current evidence does not show an increased risk of miscarriage or stillbirth following vaccination against COVID-19.

The MHRA says 'there is also no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of congenital anomalies or birth complications.'

Like most vaccines and medicines, clinical trials of COVID-19 vaccines in pregnant women were not carried out before the use in the general population. However, evidence from non-clinical studies of the COVID-19 vaccines available in the UK has not raised any concerns about safety in pregnancy. 

One reason is the mRNA vaccines do not contain living organisms that can multiply in the body, so they cannot infect an unborn baby in the womb.

Moreover, the current advice of the Joint Committee on Vaccination and Immunisation is that the COVID-19 vaccines should be offered to those who are pregnant at the same time as non-pregnant individuals based on their age and clinical risk group.

You can also find more information from The Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives decision guide about receiving the COVID-19 vaccine and other helpful information.

For further advice, speak to a healthcare professional looking after you in your pregnancy.

Note: As of September 6, 2021, only thirty countries do NOT recommend pregnant women receive a COVID-19 vaccine, according to the COVID-19 Maternal Immunization Tracker, produced by Johns Hopkins University. And as of August 30, 2021, the U.S. CDC reported (135) pregnant women with COVID-19 have died since January 2020.

Pregnant & Breastfeeding Women COVID-19 Vaccine Research-Based news is published at this link.

Sep 6, 2021 • 9:43 am CDT

The European Medicines Agency (EMA) confirmed on September 6, 2021, it has started evaluating an application for the use of a booster (3rd) dose of the mRNA Comirnaty (Pfizer - BioNTech) vaccine to be given 6 months after the second dose in people aged 16 years and older.

The EMA’s committee will carry out an accelerated assessment of data submitted by the company that markets Comirnaty, BioNTech Manufacturing GmbH, including results from an ongoing clinical trial in which around 300 adults with healthy immune systems received a booster (3rd) dose approximately 6 months after the second dose.

While these evaluations are ongoing, the EMA and the European Centre for Disease Prevention and Control (ECDC) have highlighted their current position on September 2nd regarding the need for additional and booster doses of COVID-19 vaccines in a separate communication.

'It is important to distinguish between booster doses for people with normal immune systems and additional doses for those with weakened immune systems.'

Although the EMA and ECDC do not consider the need for COVID-19 vaccine booster doses to be urgent in the general population, the EMA is evaluating the present application to ensure evidence is available to support further doses as necessary. 

The European Medicines Agency is a decentralized agency of the European Union (EU) responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. An independent Management Board governs EMA.

Sep 5, 2021 • 12:25 pm CDT

Geneticists in South Africa have issued an alert regarding a new SARS-CoV-2 betacoronavirus variant, announced GAVI on September 1, 2021.

The C.1.2 variant has captured these geneticist interests because it carries several genetic mutations similar to those found in other highly transmissible variants, which can evade the immunity generated by COVID-19 vaccines to some degree.

Although it shares some similarities with that original C.1 variant, C.1.2 has “mutated substantially” beyond the original Wuhan strain of the coronavirus, according to researchers at South Africa’s National Institute for Communicable Diseases.

Both the WHO and the South African National Department of Health were alerted to the circulation of C.1.2 in July 2021.

The World Health Organisation has not yet labeled C.1.2 a “variant of interest” or a “variant of concern." This means there isn’t yet evidence of significantly increased transmissibility, susceptibility to disease, and/or decreased effectiveness of public health and social measures, diagnostics, vaccines, or therapeutics associated with C.1.2.

Moreover, there is not enough evidence to know whether it spreads more easily or poses a serious threat to efforts to prevent COVID-19 at the current time, says GAVI.

Sep 4, 2021 • 1:00 pm CDT

Publishing as a non-peer-reviewed preprint study on August 25, 2021, researchers led by Tal Patalon and Sivan Gazit at Maccabi Healthcare Services in Tel Aviv, Israel, analyzed a healthcare database containing information about 2.5 million Israelis.

They examined new SARS-CoV-2 betacoronavirus infections in people who had never been infected but had been vaccinated with the mRNA Comirnaty (Pfizer - BioNTech) vaccine, and those who were not yet vaccinated but had recovered from COVID-19, and in people who had received one dose of Comirnaty and had also previously had COVID-19.

These researchers found that Israelis who had never been infected and were vaccinated in January and February were 6-13 times more likely to become infected during June – August 2021, when the Delta variant was the dominant strain circulating in Israel unvaccinated people who had recovered from SARS-CoV-2.

They also compared two groups of 14,000 unvaccinated people who had recovered from SARS-CoV-2 with a similarly sized group of people who had previously been infected and had received one dose of the Comirnaty vaccine.

The research team found that the previously infected but unvaccinated group was 2x as likely to be reinfected as those previously infected and received one dose of the Comirnaty vaccine.

The study indicates that the natural immunity gained through becoming infected and recovering from SARS-CoV-2 is of great value in protecting against future disease.

Moreover, this protection is further enhanced when combined with COVID-19 vaccination.

'It’s important to note that although natural immunity can be highly protective, it can come at a great cost – millions haven’t survived COVID-19, and others have suffered severe disease and hospitalization, said GAVI in a statement issued on August 31, 2021.

Sep 4, 2021 • 5:17 am CDT

The US Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report published on September 3, 2021, disclosed new data on COVID-19 hospitalization rates in children and adolescents, which show in states with low vaccination rates, hospitalizations increase four times compared to states with high vaccination rates.

The percent of ED visits in August 2021 in the quartile of states with the lowest vaccination coverage was 3.4 times that in the quartile of states with the highest vaccination coverage.

Furthermore, this analysis found that the percentage of COVID-19 hospitalizations resulting in ICU admission has remained near 20% since Delta became the predominant SARS-CoV-2 virus variant.

This CDC reported reconfirms 'Although COVID-19 generally results in milder disease in children and adolescents than in adults, severe illness from COVID-19 can occur in children and adolescents and might require hospitalization and intensive care unit support.

Sep 3, 2021 • 1:23 pm CDT

The Pan American Health Organization (PAHO) launched a new platform on September 1, 2021, to ease the severe shortage of COVID-19 vaccines in Latin America and the Caribbean. 

So far, about 23% of people in the PAHO region have been fully COVID-19 vaccinated, and coverage is much lower in many countries.

During a recent virtual meeting, PAHO Director Carissa F. Etienne announced the Regional Platform to Advance the Manufacturing of COVID-19 Vaccines and other Health Technologies in the Americas.”

She described it as an initiative that will “coordinate across sectors – health, science and technology, and industry - to strengthen their capacity to produce new technologies.”

Explaining the need for the platform, Dr. Etienne added, “limited (global) production and unequal distribution of vaccines in the face of staggering demand hinder our COVID response."

"Mass vaccination is critical if we are to stem the tide of this pandemic and hinder the spread of further variants.”

“Vaccination rates remain in the teens in several Caribbean and South American countries, and coverage is still in the single digits in Central American nations like Guatemala, Honduras, and Nicaragua,” she continued.

Dr. Etienne said that in total, 540 million COVID-19 vaccine doses must be delivered to ensure that all countries in Latin America and the Caribbean can cover at least 60% of their populations.

“So we must expand vaccine access in our region, especially in the places that are lagging,” she said.

The first initiative under the platform is to facilitate the transfer to the region of the mRNA vaccine technology used in highly effective COVID-19 vaccines.  The PAHO has received 32 proposals from private and public companies that want to participate in the endeavor.

The platform will support collaboration across countries and cooperation agencies, applying existing regional biomanufacturing capacity to the production of COVID-19 vaccines and other medical technologies. The principle is that manufacture should benefit the entire region, with regional pharmaceutical production and distribution of the vaccines by PAHO’s Revolving Fund to all countries.