Coronavirus Breaking News

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

Oct 19, 2021 • 4:53 pm CDT

Ireland's Minister for Health, Stephen Donnelly TD, announced several updates to Ireland's COVID-19 Vaccination Programme on October 19, 2021.

These updates follow the National Immunisation Advisory Committee (NIAC) recommendation to the Chief Medical Officer.

The NIAC recommended a booster dose of the mRNA Comirnaty® (Pfizer-BioNTech) COVID-19 vaccine be offered to those aged 60 to 79 years who have completed their primary course with any COVID-19 vaccine.

The Comirnaty booster dose should ideally be given six months following the primary two or one-dose vaccination schedule.

However, if a person for whom a booster dose is recommended had a laboratory-confirmed COVID-19 infection after the primary vaccine course, known as a Breakthrough Infection, the booster dose should be delayed for at least six months.

Minister Donnelly said in a press statement, "Since Ireland's Vaccination Programme began late last year, I have announced several updates of the vaccine prioritization program, each with the same aim - to protect those most at high risk from severe illness and death from COVID-19."

"The roll-out of the booster program continues to rely on using vaccines which are safe and effective, and in doing so, means that we are continuing to prioritize our at-risk loved ones."

Ireland's actions are related to the European Medicines Agency, which concluded on October 4, 2021, that booster doses may be considered at least six months after the second dose for people aged 18 years and older. At a national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data.

Oct 19, 2021 • 11:04 am CDT

The U.S. Food and Drug Administration announced an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback's request for an emergency use authorization (EUA) for molnupiravir, an investigational antiviral drug to treat COVID-19.

On November 30, 2021, the AMDAC will meet to discuss the available data supporting the use of molnupiravir to treat mild-to-moderate COVID-19.

Molnupiravir is an oral antiviral developed initially to treat influenza. Molnupiravir is a bioavailable form of a potent ribonucleoside analog that inhibits replicating multiple RNA viruses, including SARS-CoV-2, the causative agent of COVID-19.

"The FDA is evaluating the safety and effectiveness data submitted by Merck and Ridgeback in their emergency use authorization request for molnupiravir, a new oral treatment for high-risk individuals with a newly diagnosed COVID-19 infection."

"We believe that, in this instance, a public discussion of these data with the agency's advisory committee will help ensure a clear understanding of the scientific data and information that the FDA is evaluating to decide whether to authorize this treatment for emergency use," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research, in a press release.

The agency may convene an advisory committee to solicit advice from independent outside experts on various complex scientific, technical, and policy issues at the FDA's discretion.

The FDA does not always convene an advisory committee meeting in connection with EUA reviews but may do so under certain circumstances when discussion with the advisory committee will help inform agency decision making.

The FDA intends to live stream the AMDAC meeting on the agency's webcast from the FDA website.

Oct 19, 2021 • 6:10 am CDT
Wikipedia

"We had to go and find people willing to be vaccinated against COVID-19, now they come by themselves!" exclaims Mr. Elhadi Sidi Mohamed, head of the vaccination site at the National Hospital Center in Nouakchott, Mauritania, on October 15, 2021. 

"At the launch of the third vaccination campaign, we even had too many people here."

"Everyone wanted to be the first to be vaccinated."

In early September 2021, Mauritania became the 12th country on the African continent to reach the World Health Organization (WHO) 's goal of vaccinating at least 10% of the population against COVID-19 by the end of September.

As of early October, more than 580 000 people have been fully vaccinated against COVID-19, representing 12% of Mauritania's population of about 4.5 million.

Officially known as the Islamic Republic of Mauritania, it received its first doses of the COVID-19 vaccine in December 2020 through a bilateral agreement with China.

The first vaccination campaign, launched in March 2021, was met with a cool reception.

When the second vaccination campaign was launched in June, only 30 000 people had been vaccinated.

There was a lot of reluctance, and rumors about the danger of the vaccines were circulating on social networks. So much so that 120 000 doses of AstraZeneca's Vaxzevria vaccine were almost lost, as no one could find takers before the expiration date.

Vaxzevria is made from a virus (ChAdOx1), a weakened version of a common cold virus. In addition, genetic material has been added to the ChAdOx1 construct, used to make proteins from the SARS-CoV-2 betacoronavirus called Spike glycoprotein.

The Vaxzevria vaccine does not contain the ChAdOx1 virus itself and cannot cause COVID-19, says the European Medicines Agency.

Oct 18, 2021 • 7:23 pm CDT

The United Kingdom's government dashboard revealed today COVID-19 cases reached a 3-month high of 49,156 patients.

This data reflects a 16.2% increase in COVID-19 cases from the previous week.

This interactive map shows a 7-day case rate per 100,000 people in the U.K.

And SARS-CoV-2 virus variants of concern continue to shift ratios.

Dr. William Welfare, Incident Director at the U.K. Health Security Agency stated on October 14, 2021, 'Case rates of COVID-19 remain high across the country and have been slowly rising.'

'As winter approaches, help protect yourself against COVID-19 and flu by washing your hands regularly and wearing a mask in crowded places.'

'When meeting people inside, open windows and doors to ventilate the room.'

'If you are offered a vaccine for either COVID-19 or flu, please take it. If you have any COVID-19 symptoms, get a PCR test.'

About 79% of people in the U.K. over 12 years of age have received two or more COVID-19 vaccine doses as of October 18, 2021. This data compares with the U.S., where the U.S. CDC confirmed 57% of the population is fully vaccinated with two doses.

: data up to 13 October 2021

Oct 18, 2021 • 4:18 pm CDT

The European Medicines Agency (EMA) confirmed today it has started evaluating an application to extend the use of BioNTech-Pfizer's Comirnaty COVID-19 vaccine to children aged 5 to 11.

Comirnaty was first Authorized in Europe during December 2020 and is currently Authorized for use in people aged 12 and older.

The EMA's human medicines committee will review the data on the vaccine, including results from an ongoing clinical study involving children aged 5 to 11, to decide whether to recommend extending its use.

In the U.S.A., Comirnaty was also Authorized for use in December 2020 but has since been Approved by the U.S. FDA.

The FDA's vaccine committee has scheduled a session on October 26, 2021, to discuss a request to amend Pfizer-BioNTech's Authorization to administer their COVID-19 mRNA vaccine for children 5 through 11 years of age.

Germany-based BioNTech S.E. and New York-based Pfizer, Inc. co-developed the Comirnaty (BNT162b2) vaccine to prevent severe COVID-19 caused by the SARS-CoV-2 betacoronavirus. It is a nucleoside-modified RNA formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen.

The EMA is a decentralized agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines. An independent Management Board governs the EMA. The European Commission makes final decisions.

Separately, Health Canada stated today it will prioritize the review of Pfizer's submission while maintaining high scientific standards for safety, efficacy, and quality.

"Health Canada will only authorize the use of Comirnaty if the independent and thorough scientific review of all the data included in the submission showed that the benefits of the vaccine outweighed the potential risks in this age group," the statement said.

Oct 16, 2021 • 2:25 pm CDT

New Jersey-based Johnson & Johnson announced on October 15, 2021, the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for a 'booster' dose of the Janssen COVID-19 vaccine for adults aged 18 and older.

In the U.S., there is sufficient supply to support boosting to those who have received the more than 15 million doses of the Jenssen COVID-19 vaccine that have been administered as primary vaccinations.

The booster dose should be administered at least two months following the initial single-shot vaccination.

When given as a booster or primary dose, the vaccine is generally well-tolerated, with no new safety signals observed in the two-dose ENSEMBLE 2 trial compared with single-dose studies.

"Today's recommendation is based on the totality of the evidence, with clinical and real-world data showing that while a single shot offers strong and long-lasting protection against COVID-19, a booster given after the single-dose primary vaccination increases protection, in particular against symptomatic COVID-19," stated Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, in a press release.

The single-shot COVID-19 vaccine, developed by its Janssen Pharmaceutical Companies of Johnson & Johnson, received initial EUA in the United States on February 27, 2021, and Conditional Marketing Authorization by the European Commission on March 11. The World Health Organization issued Emergency Use Listing on March 12, 2021, and the Company received an interim recommendation by the Strategic Advisory Group of Experts on Immunization on March 17, 2021.

Many more authorizations have been granted in countries worldwide, and various regulatory submissions are ongoing.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit www.jnj.com/covid-19.

Oct 14, 2021 • 12:16 pm CDT

According to local media, a México state-based federal judge ordered Mexican health authorities to modify the national vaccination policy to include minors in the COVID-19 vaccination program.

Mexico News Today reported on October 12, 2021, the judge ruled that about 10 million people under 18 years of age must be immunized with the Pfizer (Comirnaty) mRNA vaccine.

The judge determined there was no impediment to an order applying to all youths because 'healthcare access is a universal human right.'

The Mexican government has until October 14, 2021, to comply with the order.

However, the federal Health Ministry could choose to challenge the injunction, a move that would prompt a review process that could take weeks.

Previously, Mexico's President López Obrador had maintained the government wouldn't vaccinate minors en masse with COVID-19 vaccines until international health authorities recommend it.

However, in September 2021, the Mexican federal government announced it would offer COVID-19 vaccines to more than 1 million children with disabilities and illnesses.

The US Centers for Disease Control and Prevention (CDC) has issued a Level 3 Travel Health Notice for Mexico due to COVID-19, indicating a high level of disease transmission in the country.

The CDC says, 'Your risk of contracting COVID-19 and developing severe symptoms may be lower if you are fully vaccinated with an FDA authorized vaccine.'

'Before planning any international travel, please review the CDC's specific recommendations for vaccinated and unvaccinated travelers.'

Moreover, visit the US Embassy's COVID-19 page for more information on COVID-19 in Mexico.

Additionally, the US Department of State issues Mexico state summaries and advisories. Some areas of Mexico have an increased risk of crime and kidnapping.

Oct 14, 2021 • 11:24 am CDT

A new assessment by the World Health Organization (WHO) published on October 14, 2021, shows that about 14% of COVID-19 infections are detected in Africa.

The WHO analysis used the COVID-19 calculator that found that as of October 2021, the cumulative number of COVID-19 infections is estimated to be 59 million in Africa, which is seven times more than the over 8 million cases reported.

Since the start of the COVID-19 pandemic in late 2019, and as of October, more than 70 million COVID-19 tests have been reported by African countries, which is a fraction of the continent's 1.3 billion people.

By contrast, the United States, with about a third of the population, has reportedly administered over 580 million tests. In contrast, the United Kingdom, with less than 10% of the people of Africa, has administered over 280 million tests.

To reverse that trend and curb transmission, the WHO Regional Office for Africa today announced a new initiative to enhance community screening for COVID-19 in eight countries.

The new testing program aims to reach more than 7 million people with rapid diagnostic tests in the next year.

"Test numbers have been rising in Africa, but this community-based initiative is a radically new approach that should help significantly raise detection rates. More testing means rapid isolation, less transmission, and more lives saved through targeted action," said Dr. Matshidiso Moeti, WHO Regional Director for Africa.

As of October 8, 2021, the percentage of COVID-19 nucleic acid amplification tests that are positive reached 6.1% for the previous seven days in the USA.

And the U.S. FDA confirmed as of October 12, 2021, it had authorized 416 coronavirus diagnostic tests, including molecular tests, antibody tests, and antigen tests during the COVID-19 pandemic. Furthermore, molecular authorizations can be used with home-collected samples.

Oct 12, 2021 • 3:19 pm CDT

The Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) announced a Call for Proposals on October 11, 2021, to fund clinical trials evaluating the impact of reduced booster doses and third doses of COVID-19 vaccines.

In particular, the CEPI research program is inviting applications from individual organizations and consortia, including COVID-19 vaccine developers, to assess whether smaller doses of a single COVID-19 vaccine booster shot—as opposed to a full booster dose—would improve, broaden, and prolong the immune response following a primary series of COVID-19 vaccination.

Administering smaller vaccine shots—also known as fractionation—has previously been used to maximize global vaccine supply during Yellow fever and Polio outbreaks.

Currently, there are over twenty COVID-19 vaccines in use globally, with about 100 vaccine candidates conducting clinical trials, according to GAVI.

CEPI will make up to the US $25m funding available as part of the Call to fund several clinical trials looking at dose-sparing booster shots for different COVID-19 vaccine candidates.

The findings from the CEPI-funded trials are expected to provide essential data to inform the public health and scientific community, including groups like the National Immunisation Technical Advisory Groups and the WHO Strategic Advisory Group of Experts on Immunization on the potential merits of vaccinating people with fractional doses of COVID-19 vaccine.

Oct 10, 2021 • 10:32 am CDT

Iceland's Directorate of Health announced on October 8, 2021, as there is a sufficient supply of Pfizer vaccine (Comirnaty) available in Iceland for both the pre-vaccine activation vaccines and the primary vaccinations of those who have not yet been vaccinated, the Epidemiologist has decided that the Moderna (SpikeVax) vaccine will not be used in Iceland.

In recent days, there has been data from the Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna and Pfizer / BioNTech vaccines.

This heart issue seems to apply regardless of which mRNA vaccine was given as the first dose, reported Norway.

And in Sweden, the use of Moderna has recently been restricted to individuals born before 1991.

Iceland's Health leaders have only recommended the Pfizer / BioNTech vaccine for primary vaccination at 12–17 years.

Additional news from Iceland's Health Directorate is available at this weblink.

Oct 9, 2021 • 7:26 am CDT

The state of Alaska currently has the highest number of COVID-19 cases in the last week per 100,000 population in the USA. In addition, Alaska's health department recently stated, 'Hospital capacity is reaching a point in Alaska where it may become difficult to care for everyone who needs care.'

Alaska's average coronavirus test positivity rate over the last week was 9.48%.

And, only 58.6% of Alaskans 12 and older have been fully vaccinated.

The state Division of Public Health released a comprehensive look at hospitalizations, deaths, and vaccine breakthrough cases since the start of the COVID-19 pandemic through August 2021.

August saw an increase in coronavirus-related deaths. More men than women have died with COVID-19. The COVID-19 death rate is highest among Native Hawaiian/Pacific Islander, Alaska Native, and Asian populations.

Also, 19% of all COVID-19 hospitalizations and a third of all cases involved vaccinated people.

The data showed that the incidence of COVID-19 among vaccinated people was consistently lower than among people who weren't vaccinated.

In July and August 2021, among people 12 and older who have had COVID-19, reinfection incidence was 24% higher among unvaccinated persons than those who were fully vaccinated.

This indicates that if someone was previously infected, getting vaccinated provided even greater protection against the SARS-CoV-2 virus.

Furthermore, Alaska's data also shows a ninefold reduction in the risk of hospitalization among people who are fully vaccinated.

'Choosing to get vaccinated is the single most important action you can take to protect yourself and your community,' announced Alaska's Twitter account. 'The higher the vaccination rate, the more protected community members are from COVID-19.'

Learn more about the COVID-19 vaccines at covidvax.alaska.gov.

Oct 9, 2021 • 6:54 am CDT

In Colorado, the UCHealth hospital system recently stated, 'people on its organ transplant waitlist won't be offered an organ if they refuse to get the COVID-19 vaccine.'

According to NPR reporting on October 7, 2021, UCHealth, which operates 12 hospitals from its headquarters in Aurora, Colo., stated on Facebook, 'it has long been standard practice to require many organ recipients or donors to get vaccines such as hepatitis B or the MMR shot.'

The Colorado hospital system added COVID-19 to its required vaccine list recently.

Oct 6, 2021 • 1:03 pm CDT

In the earliest days of the COVID-19 pandemic, the medical community turned to a century-old treatment: Take blood from recovered patients and give it to the sick, stated a press release issued by the University of Pittsburgh School of Medicine (UPMC) on October 4, 2021.

The hypothesis was that components in the so-called “convalescent plasma” that fought off the disease once could do it again, which has worked in other diseases, such as Ebola.

However, an international research team, which included the UPMC physician-scientists and patients, effectively ended that practice.

A phase 4 clinical trial has concluded convalescent plasma is “futile” as a COVID-19 treatment for most critically ill patients.

But the researchers could not determine why convalescent plasma did not improve outcomes in most critically ill patients.

“There were biologically plausible reasons to turn to convalescent plasma early in the COVID-19 pandemic when hundreds of thousands of people were getting sick, and treatments had yet to be discovered,” said co-lead author Bryan McVerry, M.D., associate professor of pulmonary, allergy, and critical care medicine at Pitt and a UPMC intensivist.

“Unfortunately, it was either being administered outside of clinical trials or in trials that weren’t focused on critically ill patients, slowing our ability to see if it worked.”

“Finally, with these results, we can put an end to using convalescent plasma for our sickest COVID-19 patients and focus on treatments that we know work, as well as developing and testing better ones.”

However, the results followed a slightly different pattern for the 126 patients who were immunocompromised.

This group appeared to do slightly better with the convalescent plasma treatment than the standard treatment, but the number of patients was too small to make a definitive statement.

The immunoglobulin domain randomized participants received two units of high-titer, ABO-compatible convalescent plasma (total volume of 550 mL ± 150 mL) within 48 hours of randomization.

“It could be that patients with an impaired immune system, who are unable to mount an effective immune response, could still benefit from the antibodies present in blood plasma from COVID-recovered patients, especially early on in the illness,” said corresponding author Lise Estcourt, M.D., an associate professor of hematology and transfusion medicine at the Oxford University’s Radcliffe Department of Medicine and director of the U.K.’s National Health Service Blood and Transplant Clinical Trials Unit.

“This is something that definitely warrants investigation.”

The results are published in JAMA concurrent with a presentation at the European Society of Intensive Care Medicine’s annual meeting.

Oct 5, 2021 • 3:18 pm CDT

California-based ACON Laboratories, Inc. announced on October 4, 2021, that its Flowflex™ COVID-19 Antigen Home Test had been Authorized by the U.S. Food and Drug Administration (FDA). 

This FDA Emergency Use Authorization will allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

Flowflex may be used for self-testing by individuals aged 14 years and older or with adult-collected nasal swabs from children as young as two years old.

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test available for purchase without a prescription.

In contrast to other home tests, which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms.

Flowflex COVID-19 tests are available in many countries, including widespread distribution in the U.K. through the National Health Service.

Headquartered in San Diego, California, ACON's U.S. office centers strategic management, administration, business development, innovative research, and development. The Company's state-of-the-art manufacturing facility located in Hangzhou, China is ISO13485: 2016 certified, FDA registered and inspected by the FDA.

Oct 4, 2021 • 9:17 pm CDT

Throughout the COVID-19 pandemic, there has been much uncertainty about how long immunity lasts after someone who is unvaccinated is infected with the SARS-CoV-2 betacoronavirus.

Now a team of scientists led by faculty at Yale School of Public Health and the University of North Carolina at Charlotte believes they have found an answer.

“Reinfection can reasonably happen in three months or less,” stated Jeffrey Townsend, the Elihu Professor of Biostatistics at the Yale School of Public Health and a lead author of the study, in a press release.

"Previous infection alone can offer very little long-term protection against subsequent coronavirus infections.”

The study, published in the journal The Lancet Microbe on October 1, 2021, is the first to determine the likelihood of reinfection following natural infection and without vaccination. 

Townsend and his team analyzed known reinfection and immunological data from the close viral relatives of SARS-CoV-2 that cause “common colds” — along with immunological data from SARS-CoV-1 and MERS-CoV.

Leveraging evolutionary principles, the team was able to model the risk of COVID-19 reinfection over time.

Reinfections can and have happened, even shortly after recovery.

And they will become increasingly common as immunity wanes, and new SARS-CoV-2 variants arise.

“We tend to think about immunity as being immune or not immune. Our study cautions that we instead should be more focused on the risk of reinfection through time,” added Alex Dornburg, assistant professor of bioinformatics and genomics at the University of North Carolina at Charlotte, who co-led the study with Townsend.

“As new virus variants arise, previous immune responses become less effective at combating the virus."

"Those who were naturally infected early in the pandemic are increasingly likely to become reinfected in the near future.”

The team’s data-driven model reveals striking similarities to the reinfection risks between SARS-CoV-2 and endemic coronaviruses over time. 

“Just like common colds, from one year to the next, you may get reinfected with the same virus."

"The difference is that, during its emergence in this pandemic, COVID-19 has proven to be much more deadly,” said Townsend. 

“Due to the ability of SARS-CoV-2 to evolve and reinfect, it, too, is likely to transition from pandemic to an endemic disease,” added Dornburg.

“A hallmark of the modern world is going to be the evolution of new threats to human health,” said Townsend.

“Evolutionary biology — which provided the theoretical foundations for these analyses — is traditionally considered a historical discipline. However, our findings underscore its important role in informing decision-making and provide a crucial stepping stone toward robust knowledge of our prospects of resistance to SARS-CoV-2 reinfection.”

Co-authors include researchers from Temple University. The U.S. National Science Foundation provided funding for the research.