Coronavirus Breaking News

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

Nov 5, 2021 • 2:41 pm CDT

In this analysis of U.S. college athletes playing football games during the COVID-19 pandemic published by the JAMA Network on October 29, 2021, no instances of in-game SARS-CoV-2 coronavirus transmission were found.

These researchers from Texas A&M University, Florida, and LSU found low SARS-CoV-2 inter-team transmission risk in college football when rigorous and multipronged protection strategies were implemented.

Despite 12% of athletes testing positive for SARS-CoV-2, only 18 had competed during the preceding 48 hours, and no downstream infections to opposing team members were apparent.

Actual contacts were exceedingly brief, even when accumulated over an entire game.

In-game close contact was rare, not associated with SARS-CoV-2 transmission, and no U.S. CDC-defined close contact exposures were observed.

Between September and December 19, 2020, over 1,100 college football athletes had 109,762 opposing-player interactions over 64 SEC regular-season games.

These interactions were fleeting (median length, 6 seconds), and most (95%) were briefer than 26 seconds. And the accumulated contact time between players during a single game was fewer than 23 seconds.

This finding suggests gameplay during a COVID-19 pandemic did not seed outbreaks.

Implications of sporting events and other game-related activities, such as training and travel, warrant more extensive analysis of SARS-CoV-2 transmission in athletic organizations and communities.

And further analysis of specific contact types, positions stopped clock or pregame and postgame periods, environmental conditions, and contact between teammates, referees, coaches, and other individuals onfield during games, along with clinical and public health case data, could shed additional light on SARS-CoV-2 infection and transmission among athletes.

In conclusion, these researchers stated, 'Even during a pandemic, infectious diseases can be effectively monitored and prevented during contact sports through multipronged and innovative strategies that leverage traditional public health practices and applied technologies.'

Nov 5, 2021 • 5:54 am CDT

The U.S. Food and Drug Administration (FDA) reissued an emergency use authorization (EUA) for the OraSure Technologies InteliSwab COVID-19 Rapid Test on November 1, 2021.

The InteliSwab COVID-19 Rapid Test gives results in 30 minutes.

The FDA authorized the InteliSwab COVID-19 Rapid Test as a single test without a prescription for people with COVID-19 symptoms.

The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms and as a single-use test with a prescription for symptomatic people suspected of COVID-19 by their healthcare provider.

Indications: Non-prescription home use for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 with:

  • Self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
  • Adult-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first seven days of symptom onset.
  • Self-collected anterior nasal (nares) swab samples from individuals aged 18 years or older, or adult collected anterior nasal swab samples from individuals aged 15 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.

The FDA is committed to helping increase the availability of accurate and reliable at-home COVID-19 diagnostic tests and facilitating consumer access to these tests.

As of early November 2021, the FDA authorized 421 tests and sample collection devices under EUAs.

These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 38 antigen tests. In addition, there are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples.

Also, there is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, nine EUAs for antigen over-the-counter (OTC) at-home tests, and three EUAs for molecular OTC at-home tests.

The FDA has also authorized 672 revisions to test EUA authorizations.

Nov 5, 2021 • 4:09 am CDT

Oxford Languages, the creator of the Oxford English Dictionary, announced on November 1, 2021, it chose "vax" as its Word of the Year for 2021.

"By September 2021, it was over 72 times more frequent than at the same time last year," Oxford said.

The use of the word 'Vax' can be either a noun or a verb.

And it's spawned various derivatives, including "vax cards" and "being fully vaxxed," according to Oxford.

Consumer emotions regarding the word "vax" are not universal.

Many people see the promise of protection against COVID-19 provided by the vaccine as a welcome scientific advancement.

Others view the new drug with skepticism.

This attitude may be why the U.S. trails most developed countries in the percentage of population fully-vaxxed.

According to the U.S. CDC, less than 59% of the people in the U.S.A are fully-vaxxed, as of November 4, 2021.

Nov 5, 2021 • 3:54 am CDT

The European Centre for Disease Prevention and Control (ECDC) reported at the end of week #43 (week ending October 31, 2021), the overall epidemiological situation in the EU/EEA was characterized by a high and increasing overall COVID-19 case notification rate.

Case notification rates, death rates, hospital and ICU admissions are forecast to increase over the next two weeks.

Case notification rates are currently highest among age groups under 50 years old, but notification rates among older age groups are increasing.

The picture varies considerably between EU/EEA countries.

However, increasing case notification rates and an overall epidemiological situation of high or very high concern are now observed in countries across the EU/EEA.

As an example, Germany reported 33,949 new SARS-CoV-2 coronavirus infections on November 4, 2021.

Health Minister Jens Spahn declared the fourth wave of the virus was "in full force" across Germany, reported DW news.

ECDC publishes these maps to support the coordinated approach to the restriction of free movement in response to the COVID-19 pandemic.

In response, the WHO announced this week it had Listed an 8th COVID-19 vaccine for use globally.

Nov 4, 2021 • 9:29 am CDT

UK-based Vaccitech plc today announced the publication in The Lancet Microbe of the first Phase 1 clinical trial conducted in the Middle East, evaluating the safety and tolerability of the ChAdOx1 MERS vaccine candidate.

The ChAdOx1 MERS vaccine candidate was generally well tolerated and induced both humoral and cellular immune responses, which continued through the six-month follow-up period.

The Phase 1 trial is part of a collaboration between the University of Oxford's Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC). It is the first vaccine clinical trial to be conducted within the Kingdom of Saudi Arabia.

Vaccitech retains commercial rights to the vaccine.

"The high fatality rate of diagnosed MERS-CoV makes it one of the most dangerous coronaviruses communicable between humans," says Naif Alharbi, KAIMRC, DPhil, vaccinologist, and co-principal investigator on the MERS vaccine trial, in a press release issued on November 4, 2021.

"Research into robust preventative measures for a virus with pandemic potential is a global health imperative."

"The completion of our trial is the latest achievement for KAIMRC's world-leading MERS research and supports advancing the ChAdOx1 MERS vaccine candidate into its next phase of development."

"This multi-partner experience has also set the stage for more MERS vaccine clinical development in KSA, improving both research and regulatory expertise."

The study builds on the first Phase 1 clinical trial of ChAdOx1 MERS (Middle Eastern Respiratory Syndrome) conducted in the United Kingdom and published in Lancet ID in April 2020.

First identified in 2012 in Saudi Arabia, MERS is a zoonotic viral respiratory illness caused by the highly pathogenic MERS coronavirus. The source of the viral virus remains unknown, says the U.S. CDC.

More than 2,500 cases of MERS were reported globally to the World Health Organization (WHO), including 886 deaths. The MERS case fatality rate (34%) is more significant than COVID-19, another betacoronavirus-related disease.

Scientific evidence suggests that people can be infected through direct or indirect contact with infected dromedary camels.

However, South Korea's MERS outbreak in 2015 stemmed from a single Korean man who carried the coronavirus home after a trip to the Middle East.

The WHO lists MERS-CoV as a priority pathogen for vaccine development due to its threat to global health security.

Vaccitech is a clinical-stage biopharmaceutical company located in Oxford, England, engaged in discovering and developing novel immunotherapeutics and vaccines for the treatment and prevention of infectious diseases and cancer.

Nov 3, 2021 • 10:45 am CDT

The U.S. C.D.C. Director Rochelle P. Walensky, M.D., M.P.H., confirmed her endorsed the Advisory Committee on Immunization Practices' new recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech mRNA Comirnaty vaccine.

The pediatric version of the Comirnaty vaccine is a two-dose, 10-µg dose regimen administered 21 days apart.

This C.D.C. recommendation impacts 28 million children in the U.S. and allows providers to begin vaccinating them as soon as possible.

"Together, with science leading the charge, we have taken another important step forward in our nation's fight against the virus that causes COVID-19,' commented Dr. Walensky in a press statement.

"We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine."

"As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated."

The Comirnaty vaccine is a nucleoside-modified R.N.A. formulated in lipid nanoparticles and encodes an optimized SARS-CoV-2 full-length spike protein antigen.

Comirnaty contains a molecule with instructions for producing a protein from the SARS-CoV-2 virus.

However, Comirnaty does not include the coronavirus itself and cannot cause COVID-19.

Nov 2, 2021 • 10:44 am CDT

The U.S. Safer Federal Workforce Task Force announced new guidance regarding mandatory COVID-19 vaccinations for federal employees. To promote the safety of the Federal workforce and the public they serve, agencies must grant leave-eligible employees up to four hours of administrative leave to receive any authorized COVID-19 vaccine booster shot.

Similarly, agencies must grant leave-eligible employees up to four hours of administrative leave to receive any authorized additional dose of a COVID-19 vaccine.

The administrative leave will cover the time it takes to travel to the vaccination site, receive the vaccination dose, and return to work.

Because there is currently no requirement for Federal employees to receive a vaccine booster shot or additional dose, granting duty time is not allowable in these instances.

In the case of booster shots, this policy may be applied retroactively to the time when authorized booster shots became available (i.e., no earlier than September 22, 2021, when the Food and Drug Administration (FDA) amended the emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for the use of a single booster dose).

In the case of additional doses, this policy may be applied retroactively to the time when authorized extra doses became available (i.e., no earlier than August 12, 2021, when the FDA amended the emergency use authorization for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow for the use of an additional dose in specific immunocompromised individuals).

For more information on booster shots, go to the CDC web page on COVID-19 vaccine booster shots.

For more information on additional doses, go to the CDC web page on immunocompromised patients & the COVID-19 vaccine.

Nov 1, 2021 • 3:31 pm CDT

The Buenos Aires Ministry of Health in Argentina confirmed the efficacy of the Sputnik V vaccine and others in protecting older individuals from severe COVID-19.

This recent study found that within the first five months after the start of the local vaccination campaign, COVID-19 vaccination was associated with a significant reduction in COVID-19 infection as well as a reduction in mortality.

The peer-reviewed study has been published by The Journal of the American Medical Association on October 29, 2021, showed that infection rates decreased by over 88% among those who received the complete, two-dose vaccination against COVID-19.

And, full vaccination was associated with a 96.6% reduction in mortality.

Furthermore, the entire vaccination schedule was associated with a 94.2% reduction of all-cause deaths among those aged at least 80 years and 98.2% among those aged 70 to 79 years.

These findings suggest that practical use of available COVID-19 vaccines may significantly reduce morbidity and mortality, stated these researchers.

The present analysis shows that the pragmatic implementation of a vaccination plan including different COVID-19 vaccine options in older adults in the City of Buenos Aires was associated with a significant reduction in documented COVID-19 infection and death from any cause as death presumably associated with COVID-19.

These study results suggest the need to implement mass COVID-19 vaccination strategies in the shortest possible time.

Nov 1, 2021 • 1:56 pm CDT

The Swiss Federal Council confirmed on October 20, 2021, it wants to facilitate access to the COVID certificate for people who have recovered from COVID-19.

The Federal Council seeks to facilitate access to the COVID certificate for specific groups by introducing a 'Swiss COVID certificate.'

These new certificates are to be valid in Switzerland only.

At present, people who have recovered from COVID-19 can only obtain a certificate to prove their recovery status with a PCR test result.

Under the latest proposal, Swiss COVID certificates would also be issued to anyone who can present a current positive antibody or serology test.

Certificates issued in such cases would be valid for 90 days only.

Also, the validity period for all recovery certificates issued to date (with a PCR test) is to be doubled from 180 to 365 days.

Based on the evidence currently available, this provides sufficient protection against serious illness and hospitalization.

However, as recovery certificates are valid for only 180 days in the EU, with some exceptions, this extended certificate is also only for use in Switzerland.

The Federal Council intends to postpone any lifting of certificate requirements for the time being and will continue to monitor the COVID-19 situation over the next few weeks.

The Council intends to reassess the situation in mid-November 2021 when the effects of the cooler temperatures and the schools' reopening can be evaluated.

Additional SARS-CoV-2 virus immunity news is posted on this CoronavirusToday webpage.

Oct 31, 2021 • 8:01 am CDT

Today, the Moscow-based Russian Direct Investment Fund (RDIF) announced the Kingdom of Cambodia granted an emergency use authorization to Sputnik V and the single-dose Sputnik Light vaccine.

Cambodia became the 71st country to register these Russian vaccines.

According to the RDIF, the total population of all countries where Sputnik is authorized for use now exceeds 4 billion people.

As of late October 2021, about 17 million COVID-19 vaccine doses have been administered in Columbia, reported the WHO.

Previously, Columbia has authorized three other COVID-19 vaccines.

Furthermore, the U.S. CDC updated its Travel Advisory for Cambodia on October 12th, saying 'the current situation in Cambodia is unknown. Even fully vaccinated travelers may be at risk of getting and spreading COVID-19 variants.'

'If you must travel to Cambodia, make sure you are fully vaccinated before traveling.'

The CDC also says, 'make sure you are up-to-date on all routine vaccines before visiting Cambodia. Some of these vaccines include Chickenpox, DTP, Flu, Measles-Mumps-Rubella, and Polio.

Oct 30, 2021 • 3:35 pm CDT

Researchers in Israel conducted a retrospective observational study comparing various vaccinated groups with the mRNA Comiranty (BNT162b2) produced by Pfizer-BioNTech.

Israel's rapid rollout of its COVID-19 vaccination campaign empowered these researchers to investigate the risk for additional virus infection – either a breakthrough infection in vaccinated individuals or reinfection in previously infected ones – over a more extended period than thus far described.

The findings from a non-peer-reviewed study published on October 25, 2021, demonstrated that natural immunity affords longer-lasting and stronger protection against infection, symptomatic disease, and hospitalization due to the Delta variant of SARS-CoV-2 coronavirus, compared to the BNT162b2 two-dose vaccine-induced immunity.

Notably, individuals who were previously infected with SARS-CoV-2 and given a single dose of the Comirnaty vaccine gained additional protection against the Delta variant.

However, protection provided by a third dose, administered in Israel since late July 2021, remains unknown, stated these researchers.

Specifically, this analysis demonstrates that SARS-CoV-2-naïve vaccinees had a 13.06-fold increased risk for breakthrough infection (fully-vaccinated people) with the Delta variant than those previously infected when the first event (infection or vaccination) occurred during January and February of 2021.

The increased risk was significant for symptomatic disease as well.

Broadening the research question to examine the extent of the phenomenon, they allowed the infection to occur between March 2020 to February 2021, when different virus variants were dominant in Israel, compared to vaccination only in January and February 2021.

Although the analysis results suggest waning natural immunity against the Delta variant, those vaccinated are still at a 5.96-fold increased risk for breakthrough infection.

And at a 7.13-fold increased risk for symptomatic disease compared to those previously infected.

However, SARS-CoV-2-naïve vaccinees were also at a greater risk for COVID-19-related-hospitalization compared to those previously infected.

'The advantageous protection afforded by natural immunity that this analysis demonstrates could be explained by the more extensive immune response to the SARS-CoV-2 proteins than that generated by the anti-spike protein immune activation conferred by the vaccine.'

'However, as a correlate of protection, including the role of B-Cell and T-cell immunity, this concept remains a hypothesis,' said these researchers.

This study had several limitations; there was no external funding for the project.; the authors declare they have no conflict of interest.

Furthermore, the study from Israel contrasts with the U.S. CDC's Morbidity and Mortality Weekly Report issued on October 29, 2021.

This multistate analysis of hospitalizations for COVID-19–like illness among adults aged ≥18 years during January–September 2021, in the U.S.

This study stated 'among COVID-19–like illness hospitalizations among adults aged ≥18 years whose previous infection or vaccination occurred 90–179 days earlier, the adjusted odds of laboratory-confirmed COVID-19 among unvaccinated adults with previous SARS-CoV-2 infection were 5.49-fold higher than the odds among fully vaccinated recipients of an mRNA COVID-19 vaccine who had no previous documented infection (95% confidence interval = 2.75–10.99).'

And these researchers added, 'This report focused on the early protection from infection-induced and vaccine-induced immunity, though it is possible that estimates could be affected by time.'

'Understanding infection-induced and vaccine-induced immunity over time is important, particularly for future studies to consider.'

Oct 29, 2021 • 6:05 am CDT

The Russian Direct Investment Fund (RDIF) announced on October 28, 2021, that Israeli authorities had approved the entry of individuals vaccinated with the Sputnik V vaccine.

To date, a total of 101 countries have approved the entry of people vaccinated with the Sputnik V vaccine.

The Sputnik V vaccine is not recognized by the World Health Organization or the U.S. Food and Drug Administration.

Separating authorization of COVID vaccines from vaccination certificates is another essential step to avoiding vaccine discrimination and supporting governments' efforts in safely re-opening borders for both locals and tourists, stated the RDIF.

Sputnik V is an adenoviral-based, two-dose vaccine against the SARS-CoV-2 coronavirus. Initially produced in Russia in August 2020, and now in 20 countries, Sputnik V uses a weakened virus to deliver small parts of a pathogen and stimulate an immune response.

Adenovirus is used as a "container" to deliver the coronavirus gene to cells and start synthesizing the virus's envelope proteins, "introducing" the immune system to a potential enemy. The cells then use the gene to produce the spike protein. The person's immune system treats this spike protein as foreign and produces natural defenses, antibodies, and T cells, against this protein.

The Sputnik Light vaccine is a one-dose version.

Oct 28, 2021 • 1:01 pm CDT

California-based Meissa Vaccines announced today positive preliminary data from the interim analysis of 49 patients in a Phase 1 clinical study of MV-014-212, the company's intranasal recombinant, live-attenuated COVID-19 vaccine candidate.

The data show that a single adjuvant-free dose of MV-014-212 stimulated a strong nasal IgA antibody response in seropositive and seronegative adults.

Doses ranged from 10^3 to 10^5 PFU, with the 10^5 PFU dose inducing nasal IgA antibody levels that resembled natural immunity to SARS-CoV-2. In addition, safety data at all dose levels indicate MV-014-212 is highly attenuated, with no infectious vaccine virus recovered from any participant and no serious adverse events reported to date.

The Phase 1 clinical study is still enrolling participants, and full results are expected to be presented in a scientific forum next year.

While circulating IgG antibodies are essential for preventing serious lung disease, nasal IgA antibodies are necessary for blocking infection and transmission of respiratory viruses.

Injectable vaccines typically induce only serum (IgG) antibodies that circulate in the blood, whereas intranasal vaccines also generate mucosal (IgA) antibodies in the nasal cavity.

"The preliminary clinical data indicate a single, adjuvant-free, needle-free dose of Meissa's COVID-19 intranasal vaccine can stimulate a nasal IgA antibody response similar to that seen after SARS-CoV-2 infection, with an important difference – safety," said Robert Walker, M.D., Chief Medical Officer of Meissa Vaccines, in a press release.

"The initial safety data from this trial combined with our preclinical COVID-19 data and clinical data from Meissa's RSV vaccine candidate, which was also built on the AttenuBlock platform, support continued clinical development of MV-014-212."

"We will continue to advance Meissa's COVID-19 intranasal vaccine in this Phase 1 clinical trial in adults."

"And, we plan to evaluate it as a booster to complement injectable vaccines and initiate a Phase 1 pediatric study next year."

Oct 27, 2021 • 2:46 pm CDT

Switzerland-based RELIEF THERAPEUTICS Holding SA today announced that its wholly-owned subsidiary, APR Applied Pharma Research SA reported positive interim results from its clinical trial of nasal spray Sentinox in SARS-CoV-2 virus-infected patients.

Relief also reported that data from the study suggest that Sentinox's safety and tolerability could be effective in reducing the SARS-CoV-2 viral load at the level of the nasal mucosa.

The post-market, confirmatory, interventional, randomized, placebo-controlled clinical study is expected to enroll 57 patients.

The interim analysis, based on 30 patients who have completed the study -- 10 patients for each treatment group (0.5 ml into each nostril, 3x/day, 5x/day or control group, for five days) -- showed that all patients treated with Sentinox tested negative for SARS-CoV-2 by the end of the study period (Day 21).

By contrast, one out of 10 patients in the control group was still positive by Day 21.

All subjects using Sentinox three times a day had already tested negative by visit number 7 (V7; Day 10) vs. 70% of subjects in the control group over the same study period.

At visits 4, 5, and 6, a trend in favor of the three times a day treated group vs. control group was observed (10% of patients using Sentinox tested negative at V4 vs. 0% of patients in the control arm; 40% of patients using Sentinox tested negative vs. 20% in the control arm at V5; 70% of patients using Sentinox tested negative vs. 40% at V6).

For this study, subjects were considered negative when their COVID-19 test became negative and remained negative throughout the study period.

Prof. Giancarlo Icardi, head of the Hygiene Unit of IRCCS Policlinico San Martino Hospital in Genoa and lead investigator, commented in a press release, "The interim analysis results are encouraging."

"Indeed, the preliminary efficacy data suggest that using Sentinox, in addition to standard of care, could accelerate the time to a negative SARS-CoV-2 test result, thereby allowing patients to resume their normal daily activities sooner."

"By lowering the viral load in the nasal mucosa, the use of Sentinox could help reduce the transmissibility of the virus and, consequentially, its spread."

"Moreover, it is possible that, by including a larger number of patients and clinical parameters, Sentinox will prove to be a helpful tool for improving clinical outcomes in patients with mild COVID-19 in addition to standard of care."

"In general, we expect that the positive data obtained so far will be confirmed by the end of the study."

Sentinox is an acid-oxidizing solution (AOS) containing hypochlorous acid at 0.005%, certified in Europe on February 16, 2021, as Class III Medical Device. The device is intended for irrigation, cleansing, and moistening nasal cavities.

Relief's lead drug candidate, RLF-100TM (aviptadil), a synthetic form of Vasoactive Intestinal Peptide (VIP), is in late-stage clinical testing in the U.S. to treat respiratory deficiency due to COVID-19.

Oct 27, 2021 • 12:04 pm CDT

The JAMA Network published a Research Letter on October 25, 2021, focusing on increasing COVID-19 vaccinations in 2021. Many U.S. states, North Carolina included, announced incentive programs offering lotteries for $1 million.

However, these large but uncertain financial prizes benefit only a few lucky winners and do not address access barriers or substantially increase vaccination rates.

These researchers found that providing a guaranteed small financial incentive is a potentially promising strategy for increasing COVID-19 vaccination uptake.

In this pilot program in North Carolina, incentives slowed the decline in vaccination. In addition, they promoted more equitable distribution by alleviating barriers to vaccination, particularly for low-income, Black, and Hispanic individuals.

During the baseline periods, COVID-19 vaccine initiation increased in the intervention North Carolina clinics (46.2%), declined elsewhere (−9.5%), and increased elsewhere in the state (1.7%).

From the second baseline period to the intervention period, COVID-19 vaccine initiation declined less at sites offering the guaranteed financial incentive when compared with elsewhere in the same counties (−26.4% vs. −51.1%) and the rest of the state (vs. −48.6%).

However, the use of a nonrandomized evaluation study design makes conclusions about causal effects preliminary.

In addition, the generalizability of these findings to other states and phases of the pandemic remains to be established.