Coronavirus Breaking News

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

Dec 8, 2022 • 10:19 am CST
by Kevin Lopez

The U.S. Food and Drug Administration today announced it amended the emergency use authorizations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 vaccines to include use in children as young as six months of age.

“Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on December 8, 2022.

“Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.”

For the authorization of a single booster dose of the Moderna COVID-19 Vaccine, Bivalent for children six months through 5 years of age, the FDA relied on immune response data that it had previously evaluated from a clinical study in adults. 

In addition, the FDA analyzed data from a clinical study that compared the immune response among 56 study participants 17 months through 5 years of age who received a single booster dose of monovalent Moderna COVID-19 Vaccine at least six months after completion of a two-dose primary series of the vaccine to the immune response among approximately 300 study participants 18 through 25 years of age who had received a two-dose primary series of monovalent Moderna COVID-19 Vaccine in a previous study which determined the vaccine to be effective in preventing COVID-19.

The immune response to the booster dose of the monovalent Moderna COVID-19 Vaccine in the 17 months through 5 years age group was comparable to the immune response to the two-dose primary series in the adult participants. 

With today’s action, the monovalent Pfizer-BioNTech COVID-19 Vaccine is no longer authorized as the third dose of the three-dose primary series in children six months through 4 years of age.

The amended authorizations were issued to Moderna TX Inc. and Pfizer Inc.

Dec 6, 2022 • 11:58 am CST
by Gerd Altmann

Sorrento Therapeutics, Inc. announced today it received clearance from the U.S. FDA to initiate clinical trials with STI-1557, its next-generation mRNA vaccine against SARS-CoV-2 Omicron variants.

This mRNA vaccine candidate incorporates a mutation in the furin cleavage site that prevents the S1 subunit cleavage from the spike protein from anchoring on the muscle cell membrane.

The modification was introduced to prevent the leakage of the S1 subunit from the expressed spike protein (S protein) into the blood circulation, which is known in part to potentially cause undesirable side effects in vital organ tissues following the administration of the current FDA-approved mRNA vaccines.

The mRNA is encapsulated in a Sorrento proprietary lipid nanoparticle formulation to protect mRNAs from degradation and enable the potent translation of the S protein in host cells after intramuscular delivery, thus inducing an adaptive immune response.

The preclinical work that supported this investigational new drug application was published online in Molecular Therapy Nucleic Acids on November 3, 2022, a Cell Press partner journal, and will appear in the December 2022 print issue.

Additional COVID-19 vaccine news is posted at CoronavirusToday.com/Vaccines.

Dec 6, 2022 • 8:03 am CST
by Gerd Altmann

Pfizer Inc. and Clear Creek Bio, Inc. today announced a research collaboration and exclusive license agreement to advance the discovery and development of potential inhibitors of the SARS-CoV-2 papain-like protease (PLpro) for the oral treatment of COVID-19.

PLpro is an essential enzyme, along with the main protease (Mpro), which plays an important role in viral replication.

Charlotte Allerton, Chief Scientific Officer, Anti-Infectives, and Head of Medicine Design, of Pfizer, stated in a press release on December 6, 2022, “It is critical that we try to stay ahead of the virus, continuing to advance clinical development opportunities for our current oral therapy as well as innovating through our internal programs and strategic partnerships to bring forward additional monotherapy and/or combination treatment candidates that we believe may play a role in the ongoing fight against COVID-19.”

Under the terms of the agreement, the two companies will work together to identify a PLpro candidate to progress into the clinic. At that time, Pfizer will be solely responsible for further development and commercialization activities.

Clear Creek Bio will receive an undisclosed upfront payment and is eligible for additional potential payments.

Additional COVID-19 antiviral news is posted at PrecisionVaccinations.com/Antivirals.

Dec 2, 2022 • 5:50 am CST
by Zafer P.

The U.S. CDC reported today a high percentage of U.S. adults have antibodies to the SARS-CoV-2 coronavirus, attained through vaccination, infection, or both.

The CDC's Morbidity and Mortality Weekly Report published on December 2, 2022, found from August 2021–May 2022, 41.6% of a convenience sample of adults had both anti-spike antibodies (indicating previous infection or vaccination) and anti-nucleocapsid antibodies (showing a previous infection only).

And 43.7% of these persons were possibly asymptomatically infected.

The prevalence of serologic patterns consistent with vaccination without infection was lower among certain adults who were younger.

These findings by the CDC confirm many patterns observed in other seroprevalence studies based on convenience samples that reflect increased vaccination rates among older persons and higher infection rates among younger persons.

Nov 30, 2022 • 11:24 am CST
WHO

The World Health Organization (WHO) published today the Weekly Epidemiological Update on the impact of the COVID-19 pandemic.

Globally, the WHO reported that the number of new COVID-19 cases remained stable (+2%) from 21 to November 27, 2022, with just under 2.7 million new cases reported.

The number of new COVID-19-related fatalities decreased by 5% compared to the previous week.

As of November 27, 2022, over 637 million confirmed cases and over 6.6 million fatalities have been reported globally.

Nov 30, 2022 • 9:24 am CST
by Tumisu P.

Clover Biopharmaceuticals, Ltd. and the International Vaccine Institute today announced that Clinical Infectious Diseases had published additional data from SPECTRA, a global Phase 2/3 clinical trial.

This new data showed vaccination with SCB-2019 (CpG 1018/Alum) reduced the risk of transmitting SARS-CoV-2 infection to household members, compared to placebo participants.

The study demonstrated that a household contact was 84% less likely to get a SARS-CoV-2 infection when the infected household member had received SCB-2019 compared to households where the infected household member was not vaccinated.

Among the 134 household contacts of infected household members who had received SCB-2019, there was one case of COVID-19; among the 250 household contacts of infected household members who were not vaccinated, there were 12 cases.

“These results are important for public health officials striving to control future outbreaks and indicate that vaccination with SCB-2019 considerably reduces the risk of SARS-CoV-2 spreading within communities,” said Dr. Nicholas Jackson, President of Global Research and Development of Clover, in a related press release.

“The new data on community-level impact further strengthens our confidence in SCB-2019 as a premier vaccine that can potentially play an important role in large-scale vaccination campaigns in China and globally.”

This study was performed at eight Phase 2/3 SPECTRA sites in the Philippines. Enrolled households and household contacts were monitored for three weeks to detect new COVID-19 infections.

Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein based on the original strain of the SARS-CoV-2 virus, and combined it with Dynavax’s CpG 1018 advanced adjuvant and aluminum hydroxide.

Clover is working towards completing regulatory submissions to the China National Medical Products Administration, the European Medicines Agency, and the World Health Organization for SCB-2019 by the end of 2022.

While concurrently preparing for its commercialization in China and globally upon receiving regulatory approvals.

Nov 29, 2022 • 11:04 am CST
U.S. CDC

The U.S. CDC's recent Morbidity and Mortality Weekly Report (MMWR) presented the findings from a new study focused on the U.S. FDA-approved bivalent COVID-19 mRNA vaccines.

In this study of vaccine effectiveness published on November 22, 2022, bivalent boosters provided significant additional protection against symptomatic SARS-CoV-2 infection in persons who had previously received 2, 3, or 4 monovalent vaccine doses.

And due to the waning immunity of monovalent doses, the benefit of the bivalent booster increased with time since receipt of the most recent monovalent vaccine dose.

In the United States, about 90% of adults have received at least one COVID-19 vaccine dose.

The MMWR confirmed all persons should stay up to date with recommended COVID-19 vaccinations, including bivalent booster doses for eligible persons.

Corresponding author: Ruth Link-Gelles, media@cdc.gov.

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

Nov 29, 2022 • 9:03 am CST
by Andy Leung

Fosun Pharma announced that the first batch of about 770,000 doses of the Comirnaty Original/Omicron BA.4/BA.5 bivalent vaccine dose Dispersion for Injection COVID-19 mRNA Vaccine arrived in the Hong Kong Special Administrative Region of the People's Republic of China ("Hong Kong SAR") on November 25, 2022.

The Comirnaty bivalent vaccine can be used as an alternative to the fourth dose for eligible persons aged 12 or above following the current vaccination schedule or the third dose for recovered persons.

According to official information from the Hong Kong SAR Government, Hong Kong residents can make appointments from November 27, and the bivalent vaccination will officially start on December 1, 2022.

On November 26, the Health Bureau of the Macau Special Administrative Region of the People's Republic of China ("Macau SAR") announced that, in response to the spread of Omicron variants, the Macau SAR Government had purchased Comirnaty bivalent vaccine against Omicron BA.4-5 and the toddler formulation of Comirnaty for children aged six months to 4 years.

The vaccines have arrived in Macau SAR and will be available for vaccination upon completion of the vaccine receipt procedures.

In March 2020, Fosun Pharma and BioNTech announced a strategic collaboration to develop and commercialize COVID-19 vaccines based on BioNTech’s mRNA technology platform.

Nov 29, 2022 • 8:48 am CST
by Tumisu

Shionogi & Co., Ltd. recently announced that Xocova® (Generic name: ensitrelvir fumaric acid, Code No.: S-217622) obtained emergency regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for the indication of SARS-CoV-2 infection.

Xocova® is an oral antiviral agent administered once daily for five days that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.

“We are proud to reach this landmark step which marks the start of our real contribution to people’s recovery from SARS-CoV-2 infection. Shionogi will continue to work intensively to deliver this new option for the treatment of SARS-CoV-2 infected patients not only in Japan but also throughout the world, including in low- and middle-income countries,” said Isao Teshirogi, Ph.D., in a press release on November 22, 2022.

In addition, a contract with the MHLW for the Japanese government purchasing one million courses of Xocova® is now effective in accordance with the basic agreement signed in March 2022.

The U.S. FDA previously issued Emergency Use Authorizations for the oral antiviral agents Paxlovid and Molnupiravir.

Oct 29, 2022 • 6:03 am CDT
by Oleksandr Pidvalnyi

 The European Medicines Agency (EMA) recently published clinical data that recommended adding heavy menstrual bleeding to the list of side effects of mRNA COVID-19 vaccines.

Announced on October 28, 2022, the EMA stated heavy periods, which are bleeding characterized by increased volume and/or duration, have been observed during clinical trials, from cases in the real world, and in related medical literature.

The European regulator has now concluded that there is at least a "reasonable possibility" that heavy menstrual bleeding is causally associated with these COVID-19 vaccines, reported Natalie Glover with Reuters.

Oct 27, 2022 • 11:28 am CDT
by Ryan Morrison

The World Health Organization's Weekly Epidemiological Update confirmed that the number of new weekly cases globally decreased by 15% from 17 to 23 October 2022 compared to the previous week, with over 2.6 million new cases reported.

The number of new weekly deaths decreased by 13% compared to the previous week, with over 8,500 fatalities reported.

As of October 23, 2022, over 624 million confirmed cases and over 6.5 million deaths had been reported during the pandemic.

An updated listing of COVID-19 vaccines is posted at CoronavirusToday.com/Vaccines.

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.