Coronavirus Breaking News

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

Sep 22, 2022 • 4:51 am CDT
U.S. FDA

Florida-based Veru Inc. recently announced that the U.S. Food and Drug Administration (FDA) had informed the Company of updated meeting date for the FDA’s Pulmonary-Allergy Drugs Advisory Committee to discuss the Company’s request for Emergency Use Authorization of sabizabulin for hospitalized COVID-19 patients who are at high risk for ARDS.

As of September 19, 2022, the FDA meeting has been rescheduled to November 9, 2022.

The Company has completed a positive Phase 3 COVID-19 study evaluating sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

And on August 22, 2022, Australia’s Therapeutic Goods Administration determined that sabizabulin treatment in hospitalized COVID-19 patients at high risk for ARDS qualifies for an expedited, provisional registration regulatory pathway.

The FDA has previously Approved and Authorized various antivirals (oral and IV) to treat COVID-19 infections. 

Additional COVID-19 treatment news is posted at PrecisionVaccinations.

Sep 19, 2022 • 12:39 pm CDT
by Akiragiulia P.

Pfizer Inc. and BioNTech SE recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization for COMIRNATY® COVID-19 Vaccine to standard Marketing Authorization (MA) for all authorized indications and formulations.

The companies stated in a media release on September 16, 2022, that the European Commission (EC) will review the CHMP recommendation and is expected to make a final decision in 2022. 

The conversion, if approved by the EC, applies to all existing COMIRNATY indications and formulations authorized in the EU, including Pfizer and BioNTech’s bivalent vaccines (COMIRNATY Original/Omicron BA.1 and COMIRNATY Original/Omicron BA.4-5) as booster doses for individuals aged 12 and older in the EU. 

In a separate action, the CHMP also recommended approval for COMIRNATY as a 10-µg booster (third) dose given at least six months after completion of a primary series for children 5 through 11 years of age.

COMIRNATY 10-µg was authorized in the EU in November 2021 as a two-dose primary series for children 5 through 11.

The third dose was well tolerated with a favorable safety profile and generated neutralizing antibodies against Omicron and the original wild-type virus, regardless of prior COVID-19 diagnosis.

The EC will review the CHMP opinion, and if MA is granted, the decision will be immediately applicable to all 27 European Union member states.

Sep 18, 2022 • 10:14 am CDT
U.S. CDC

Although most countries do not have mandatory quarantine rules for people who test positive, they recommend isolation until people receive a negative test result, GAVI recently reported.

The time taken to test negative after contracting COVID-19 depends on the severity of the SARS-CoV-2 virus infection and the test itself.

PCR tests that hunt out parts of viral genetic material in our bodies and amplify it so we can detect it are susceptible and can even pick up the presence of a few viral fragments.

Such fragments of viral RNA can sometimes remain in our bodies long after the infection is over and the virus has been cleared from our system.

Furthermore, lateral flow tests that look for viral proteins called antigens are less sensitive and may be less likely to give a positive result several days after the first infection.

If we test positive on a PCR test but negative on an antigen test, then we may not be infectious and have residual virus RNA.

Indeed, as the U.S. Centers for Disease Control and Prevention (CDC) says, many governments regard negative antigen test results as sufficient proof that people are not infectious anymore.

'If you were exposed to COVID-19, you should start taking precautions.'

Under new guidelines from the CDC, people who test positive can stop wearing masks if they test negative on two rapid antigen tests, taken at least 48 hours apart.

Some of these changes in guidance may be more to do with politics and shifting societal sentiments rather than science, suggested researchers in July 2022.

Emily Bruce, a microbiologist and molecular geneticist at the University of Vermont in Burlington, commented on July 22, 2022, "You can have symptoms for longer than you test positive on lateral flow."

"And I think that's because many symptoms are caused by the immune system and not directly by the virus itself."

As of September 18, 2022, the CDC has published an Isolation and Exposure Calculator to determine if you need to isolate or take other steps to prevent spreading the coronavirus.

Sep 8, 2022 • 5:05 pm CDT
by Carlos Figarella

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products, recently announced that the Chilean Public Health Institute approved a phase II clinical trial for its inactivated Omicron strain COVID-19 vaccine and trivalent COVID-19 vaccine (ancestral, Delta and Omicron variants) on August 31, 2022. 

This study is the world's first study researching multivalent inactivated COVID-19 vaccine.

The clinical trial will evaluate the immunogenicity and safety of one booster dose of the two candidate vaccines in adults who had received two booster doses of CoronaVac®, mRNA, or adenovirus vector COVID-19 vaccine.

Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC, said in a press release issued on September 6, 2022, "SINOVAC has made great progress collaborating with global partners in the development and manufacturing of the COVID-19 vaccine."

"We are proud of the fact that CoronaVac® can protect individuals as young as six months of age, and this clinical approval will allow even better vaccine protection."

The CoronaVac vaccine has been used in more than 60 countries and regions worldwide. 

Sep 5, 2022 • 4:31 am CDT
by Hannah Williams

CanSino Biologics Inc. recently announced that the National Medical Products Administration of China had granted the Company approval for its needle-free Recombinant COVID-19 Vaccine for Inhalation, Convidecia Air™.

Convidecia Air provides a non-invasive option that uses a nebulizer to change liquid into an aerosol for inhalation through the mouth, inducing comprehensive immune protection in response to the SARS-CoV-2 coronavirus after just one breath.

Studies published in The Lancet indicated that Convidecia Air could induce strong humoral, cellular and mucosal immunity to achieve triple protection and effectively contain the infection and spread of the virus.

CanSinoBIO received the approval of its clinical trial application for Convidecia Air in March 2021.

Confirmed by the company on September 4, 2022, the inhaled vaccine utilizes the same adenovirus vector technological platform as the intramuscular version Convidecia™.

Currently, CanSinoBIO has achieved steady production of various innovative vaccines and established a global supply chain, with a goal to continue to make quality vaccine products more accessible to the worldwide population.

Note: This announcement was manually translated and curated for mobile readers.

Aug 18, 2022 • 9:01 am CDT
WHO

The World Health Organization (WHO) reported (Edition 105) that the number of new weekly cases decreased by 24% during the week ending August 14, 2022, compared to the previous week. At the regional level, the number of reported new weekly cases decreased across all six WHO regions.

And the number of new weekly deaths decreased by 6% compared to the previous week, with over 15,000 fatalities reported by the WHO.

The highest numbers of new weekly deaths were reported from the USA (2,907; -4%), Japan, Brazil, Italy, and Spain.

The WHO says, 'Current trends in reported COVID-19 cases and deaths should be interpreted with caution as several countries have been progressively changing COVID-19 testing strategies, resulting in lower overall numbers of tests performed and consequently lower numbers of cases detected.'

Dr. Tedros, WHO Director-General, stated on August 17, 2022, 'With colder weather approaching in the northern hemisphere and people spending more time indoors, the risks for more intense transmission and hospitalization will only increase in the coming months, not only for COVID-19 but for other diseases, including influenza.'

'But none of us is helpless.'

'Please get vaccinated if you are not; if you need a booster, get one.' 

'Wear a mask when you can't distance and try to avoid crowds, especially indoors.'

'There is a lot of talk about learning to live with this virus, but we cannot live with 15,000 deaths a week.'

'We cannot live with mounting hospitalizations and deaths.'

'Learning to live with COVID-19 does not mean we pretend it's not there. It means we use our tools to protect ourselves and others.'

Aug 15, 2022 • 10:41 am CDT
by Gerd Altmann

The UK's Medicines and Healthcare products Regulatory Agency (UKHSA) announced today that Moderna's updated version of the COVID-19 vaccine targeting two SARS-CoV-2 coronavirus variants had been approved for adult booster doses.

In each booster vaccine dose, 'Spikevax bivalent Original/Omicron,' half of the vaccine (25 micrograms) targets the original virus strain from 2020, and the other half (25 micrograms) targets Omicron.

The Medicines and Healthcare products Regulatory Agency's (MHRA) decision is based on data from a clinical trial that showed that a booster with the bivalent  Moderna vaccine triggers a strong immune response against both Omicron (BA.1) and the original 2020 strain.

In an exploratory analysis, the bivalent vaccine was also found to generate a good immune response against the Omicron sub-variants BA.4 and BA.5.

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, commented in a press release issued on August 15, 2022, "The Commission on Human Medicines and its COVID-19 Vaccines Expert Working Group has independently reviewed the data on safety, quality, and effectiveness and agrees with the MHRA's decision."

"The virus, SARS-CoV-2, continually evolves to evade the immunity provided by vaccines."

"This novel bivalent vaccine represents the next step in the development of vaccines to combat the virus, with its ability to lead to a broader immune response than the original vaccine."

Furthermore, the Joint Committee on Vaccination and Immunisation will advise on how this Moderna vaccine should be offered as part of the deployment program.

Note: The UK press release was manually translated and curated for mobile readership.

Aug 13, 2022 • 6:18 am CDT
U.S. CDC

The U.S. CDC recently announced it was streamlining its COVID-19 guidance to help people better understand their risk, how to protect themselves and others, what actions to take if exposed to COVID-19, and what actions to take if they are sick or test positive for the virus.

"We're in a stronger place today as a nation, with more tools—like vaccination, boosters, and treatments—to protect ourselves and our communities from severe illness from COVID-19," said Greta Massetti, Ph.D., MPH, MMWR author, in a media statement August 11, 2022.

"We also have a better understanding of how to protect people from being exposed to the virus, like wearing high-quality masks, testing, and improved ventilation."

"This guidance acknowledges that the pandemic is not over, but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives."

In support of this update, the CDC continues to promote the importance of being up to date with vaccination to protect people against serious illness, hospitalization, and death.

The protection provided by the current vaccine against symptomatic infection and transmission is less than that against severe disease.

And COVID-19 vaccine protection diminishes over time, especially against the currently circulating variants.

For this reason, it is essential to stay up to date, especially as new vaccines become available, says the CDC.

On August 11, 2022, the WHO reported that in Israel, during the Omicron dominant period, the estimated vaccine effectiveness (VE) of BNT162b2 against symptomatic COVID19 was 18% (95% CI, −2 to 34) at 14 to 27 days after the first dose and 48% (95% CI, 29 to 63) at 7 to 21 days after the second dose.

Additional COVID-19 vaccine news is posted at CoronavirusToday.

Aug 9, 2022 • 3:12 pm CDT
by Gerd Altmann

Georgia-based Frontier Biotechnologies recently announced positive results from the Phase 1 clinical trial of its drug candidate, FB2001, in healthy adult volunteers.

FB2001 (Bofutrelvir) is a small molecule inhibitor of coronavirus main protease (Mpro).

A total of 120 participants received intravenous infusions of FB2001 at either single doses from 5 mg to 400 mg or multiple doses of 30 mg to 400 mg daily for five days.

The key findings from the study are as follows:

  • FB2001 was safe and well tolerated up to 400 mg per day
  • Without a pharmacokinetic enhancer, FB2001 exhibited plasma and lung drug concentrations above the in vitro antiviral EC50 value.
  • No significant difference was observed between the Chinese and American populations.

The current intravenous formulation of FB2001 is ideal for hospitalized patients with its rapid onset of action and is suited for patients with dysphagia or other problems with swallowing, says the company.

Working with clinical research organizations, regional regulatory agencies, and local clinical centers, Frontier Biotechnologies has started a pivotal Phase 2/3 study (BRIGHT trial) to enroll about 1,200 hospitalized patients in hundreds of clinical centers worldwide.

"The phase 1 data were really promising", said Dr. Michael Hu, Chief Medical Officer of Frontier Biotechnologies, "and we are confident to carry out the pivotal trial to explore the utility of the drug in reducing the time to recovery in hospitalized patients due to COVID-19."

Frontier Biotechnologies is also developing a pulmonary formulation of FB2001 that could be used in out-patient settings for the treatment of mild Covid-19, as well as for post-exposure prophylaxis.

When inhaled directly into the respiratory tract and lungs, the tissue concentration of FB2001 is much higher than that in plasma; hence, the onset of action and viral clearance could potentially be faster than that of oral therapy. 

Note: This announcement was manually curated for mobile readership.

Aug 9, 2022 • 9:09 am CDT
by Bob from Pixabay

The Danish Health Authority (DHA) recently confirmed that 'many Danes have been vaccinated with COVID-19, and many have also been infected with the virus that causes COVID-19. 

Therefore, immunity in Denmark's population is very high.

 Against this background, the vaccination program against COVID-19 has been completed for the current season as of May 2022.

Furthermore, children and young people rarely become seriously ill from COVID-19 from the SARS-CoV-2 virus variant known as Omicron. 

Therefore, from July 2022, initial COVID-19 vaccinations are no longer possible for most people under the age of 18.

And effective September 1, 2022, most young people will not be able to get the 2nd COVID-19 vaccination, reported the DHA.

However, 'quite a few children with a particularly increased risk of a serious course will have the option of vaccination, after an individual assessment by a doctor.'

And the DHA confirmed plans to resume its COVID-19 vaccination program for target groups in the autumn and winter season 2022/23.

The DHA stated on July 4, 2022, that it intends to offer booster vaccinations to people aged 50 and over in the autumn.

There will also be an offer for particularly vulnerable people under 50, e.g., people with severely weakened immune systems who a doctor has assessed would benefit from vaccination.

Note: This announcement was translated and curated for mobile readership.

Aug 7, 2022 • 5:50 am CDT
by Gerd Altmann

The Financial Times reported yesterday Emer Cooke, head of the European Medicines Agency (EMA), said in an interview that reviewing 'available (COVID-19 vaccine) data was paramount and that her agency would stand firm.'

"Irrespective of what is happening, we have to have confidence in the vaccines that we authorize, and that is our primary responsibility as we have done with all the vaccines that have been presented to us."

"All this comparison between BA.1 and BA.4/BA.5 is something I think we're over-focusing on at the moment," Cooke added on August 6, 2022.

"Promises are not enough for me."

'We are working towards possible approvals of adapted vaccines in September,' said Cooke in July 2022.

Previously, the European Centre for Disease Prevention and Control and the EMA recommended that second booster doses of the current mRNA COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease.

Additionally, residents at long-term care homes are likely at risk of severe disease and should be considered for booster doses in line with national recommendations.

However, as of July 13, 2022, the EMA stated, 'At the moment, there is no clear evidence to support giving a second booster dose to people below 60 years of age who are not at higher risk of severe disease.'

'Neither is there clear evidence to support giving early second boosters to healthcare workers or those working in long-term care homes unless they are at high risk.'

Additional COVID-19 vaccine information is posted at CoronavirusToday.com/COVID19.

Note: This EMA information from FT.com was manually curated for mobile readership.

Aug 5, 2022 • 2:21 pm CDT
by Mabel Amber

The European Commission's Health Preparedness and Response Authority (HERA) recently signed a joint procurement Framework Contract with the company HIPRA HUMAN HEALTH to supply their protein COVID-19 vaccine.

This agreement will make the HIPRA vaccine rapidly available to the participating countries as soon as this vaccine has received a positive assessment by the European Medicines Agency.

There are 14 Member States and countries participating in this joint procurement, under which they can purchase up to 250 million doses.

Commissioner for Health and Food Safety, Stella Kyriakides, stated in a media statement on August 2, 2022, "The HIPRA vaccine adds yet another option to complement our broad vaccine portfolio for our Member States and citizens."

"An increase in vaccination and boosting is essential over the coming months."

"We are working tirelessly to make sure there are vaccines available for all."

"This is our European Health Union in action – preparing ahead and being ready to act."

The joint procurement contract with HIPRA complements an already broad portfolio of vaccines secured through the EU Vaccines Strategy, including the contracts already signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, Moderna, Novavax and Valneva.

Some 4.2 billion COVID-19 doses have been secured under the EU Vaccines Strategy. 

Note: This press announcement was manually curated for mobile readership.

Aug 3, 2022 • 9:13 am CDT
by Darko Stojanovic

California-based Twist Bioscience Corporation received expanded Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay on August 2, 2022, for the qualitative detection, identification, and differentiation of SARS-CoV-2 lineages and identification of specific genomic mutations.

This expanded FDA authorization builds on the initial EUA issued in March 2021 for qualitatively detecting the SARS-CoV-2 virus.

With the expanded authorization, the reporting of the identified and differentiated SARS-CoV-2 genetic mutations and viral lineages (e.g., Delta, Omicron) to clinicians is now authorized.

The authorization also allows for the reporting of individual mutations in patient samples.

"We developed this assay in the early days of the pandemic and, while useful for detecting the presence or absence of the virus, the true value lies in receiving a comprehensive sequencing report with all identified mutations that are now available under the expanded EUA," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience, in a press release.

"We believe this assay will continue to be critical to monitor the sequence evolution of SARS-CoV-2 and is another example of our commitment to provide tools to fight the pandemic, even when it becomes endemic."

New mutations in the SARS-CoV-2 virus continue to accumulate and circulate the world, creating genetic variants of concern that may alter transmissibility or vaccine efficacy.

'The virus will continue to evolve, and we expect this capture-based assay to serve as an important new tool for viral identification, sequencing, and surveillance.'

'With this expanded EUA, we anticipate that these data will, for the first time, now enable the appropriate treatment of COVID-19,' stated the company.

Note: This press release was manually curated for mobile readers.

Aug 1, 2022 • 11:40 am CDT
Image by Tumisu

France-based Valneva SE today confirmed the signing of the amendment to its Advance Purchase Agreement (APA) with the European Commission (EC). Under this amendment, the EC Member States’ purchases of VLA2001, Valneva’s inactivated whole-virus COVID-19 vaccine, consist of 1.25 million doses in 2022.

VLA2001 is the only whole virus, inactivated, adjuvanted COVID-19 vaccine that has received marketing authorization in Europe.

The APA includes an option to purchase an equivalent quantity later this year for delivery in 2022.

Valneva stated in a media release on August 1, 2022, it expects to deliver the first vaccine doses to participating Germany, Austria, Denmark, Finland, and Bulgaria in the coming weeks.

In Europe, the European Medicines Agency has authorized six COVID-19 vaccines and is reviewing four other vaccines.

Regarding overall vaccinations, the European Centre for Disease Prevention and Control reported on July 21, 2022, that about 73% of adult Europeans had completed their primary vaccination course, while about 5.1% have been fully 'boosted' with a fourth dose.

Note: Valneva's press statement was manually curated for mobile readership.

Jul 27, 2022 • 5:56 pm CDT
from Pixabay

North Carolina-based  Brii Biosciences Limited announced today new live virus data confirming the amubarvimab/romlusevimab combination, a long-acting COVID-19 monoclonal antibody (mAb) therapy, retains neutralizing activity against the Omicron BA.4/5 and BA.2.12.1 SARS-CoV-2 subvariants.

Data from the live virus neutralization assay performed at a University of Maryland lab was certified by the U.S. NIH and NIAID and predicted that total serum concentrations of the amubarvimab/romlusevimab combination would remain greater than 170 times the level required for greater than 90% neutralization (Neut99: 0.94 μg/mL) against the live virus, 14 days post-dose. 

"As the COVID-19 pandemic continues to surge with evolving variants, these data further validate the durability and longevity of our long-acting amubarvimab/romlusevimab combination treatment and reinforce its position as a leading investigational monoclonal antibody therapy with the potential to retain activity against the most dominating strains that are circulating worldwide," commented David Margolis, M.D., MPH, Vice President and Head of Infectious Diseases Therapy Area at Brii Bio, in a press release issued on July 27, 2022.

"We're at a critical moment in the pandemic in which the new Omicron subvariants are more contagious, resulting in a sustained urgency for safe and effective treatment options."

"We look forward to continuing our discussions with global regulatory bodies as we work to advance this innovative combination therapy for COVID-19 patients in need around the world."

On December 8, 2021, the National Medical Products Administration of China approved this mAbs.

Currently, the U.S. FDA continues its evaluations.

Additional mAbs news is posted at this link.

Note: This announcement was manually curated for mobile readership.