Coronavirus Breaking News

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

Sep 2, 2021 • 9:52 am CDT

Based on current evidence, there is no urgent need to administer booster (3rd) doses of vaccines to fully vaccinated individuals in the general population, announced the European Medicines Agency (EMA) on September 2, 2021.

About 33% of adults in the EU/EEA are not fully vaccinated with 2-doses.

In this situation, the priority now should be to vaccinate all those eligible individuals who have not yet completed their recommended vaccination course, says the EMA.

This EMA recommendation is related to a technical report issued by the European Centre for Disease Prevention and Control (ECDC).

The new ECDC report also notes that additional COVID-19 vaccine doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.

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

Some studies report that an additional vaccine dose can improve the immune response in immunocompromised individuals, such as organ transplant recipients whose low initial responses to vaccination. In such cases, the option of administering an additional dose should be considered already now.

Consideration could also be given to providing an additional dose, as a precautionary measure, to older frail individuals, in particular those living in closed settings such as residents of long-term care facilities.

Moreover, current evidence on vaccine effectiveness and duration of protection shows that all vaccines Authorized in the EU/EEA are currently highly protective against COVID-19-related hospitalization, severe disease, and death.

The current list of EMA Authorized COVID-19 vaccines is published on this webpage.

The European Medicines Agency is currently assessing data on additional doses and will consider whether updates to the product information are appropriate. EMA will also be assessing data on booster doses.

In the USA, the Food and Drug Administration amended the emergency use authorizations on August 12, 2021, for both the Comirnaty Pfizer-BioNTech COVID-19 Vaccine and the SpikeVax Moderna COVID-19 Vaccine to allow for the use of an additional dose (3rd) in certain immunocompromised individuals.

Acting U.S. FDA Commissioner Janet Woodcock, M.D., stated in a press release, “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19."

"As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time."

"The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future," concluded Dr. Woodcock's statement on August 12th.

Sep 1, 2021 • 7:41 pm CDT

The New England Journal of Medicine published the findings from a Correspondence today based on the University of California San Diego Health (UCSDH) workforce experienced with SARS-CoV-2 virus infections.

On September 1, 2021, this Letter to the Editor revealed UCSDH's workforce experienced a dramatic increase in SARS-CoV-2 infections.

Vaccination with mRNA vaccines began in mid-December 2020, and by March 2021, 76% of the workforce had been fully vaccinated.

As planned, SARS-CoV-2 infections decreased dramatically by early February 2021.

Between March and June, fewer than 30 health care workers tested positive for the coronavirus each month.

Furthermore, the percentage of USCDH's fully vaccinated staff had risen to 83% by July.

However, mRNA vaccine effectiveness exceeded 90% until June, then fell to 65.5% in July.

No vaccine effectiveness data for August 2021 was disclosed in this Letter.

July case rates were analyzed according to the month in which workers with Covid-19 completed the vaccination series. For example, in workers completing vaccination in January or February, the attack rate was 6.7 per 1000 persons (95% CI, 5.9 to 7.8).

Whereas the attack rate was 3.7 per 1000 persons (95% CI, 2.5 to 5.7) among those who completed vaccination from March through May.

Among unvaccinated persons, the July virus attack rate was 16.4 per 1000 persons (95% CI, 11.8 to 22.9).

'The dramatic change in vaccine effectiveness from June to July is likely to be due to both the emergence of the Delta variant (90%) and waning vaccine immunity over time, compounded by the end of masking requirements in California and the resulting greater risk of exposure in the community,' wrote these researchers.

'Our findings underline the importance of rapidly reinstating nonpharmaceutical interventions, such as indoor masking and intensive testing strategies, in addition to continued efforts to increase vaccinations, as strategies to prevent avoidable illness and deaths and to avoid mass disruptions to society during the spread of this formidable variant.'

'Furthermore, if our findings on mRNA vaccine waning immunity are verified in other settings, booster doses may be indicated.'

Note: Institutional review board approval was obtained for the use of administrative data on vaccinations and case-investigation data to examine mRNA vaccine effectiveness. The mRNA vaccines, Comirnaty (Pfizer–BioNTech) and SpikeVax (Moderna) have previously shown efficacy rates of 95% and 94.1%,2 respectively, in earlier clinical trials.

Aug 30, 2021 • 8:38 pm CDT

The World Health Organization (WHO) confirmed on August 27, 2021, between March and the end of July 2021, the National IHR Focal Point of Saudi Arabia reported four additional cases of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection, including one associated death.

Since 2012, the Kingdom of Saudi Arabia has reported 2,178 confirmed MERS-CoV cases with 810 related deaths.

The WHO continues to monitor the epidemiological situation and conducts risk assessments based on the latest available information. However, with the current COVID-19 pandemic, the testing capacities for MERS-CoV have been severely affected in many countries since most of the resources are redirected to prevent and control the current COVID-19 pandemic.

The Ministry of Health of Saudi Arabia is working to increase the testing capacities for better detection of MERS-CoV infections.

Most MERS-CoV cases are related to contact with camels, says the U.S. CDC.

However, human-to-human transmission in healthcare settings has been associated with delays in recognizing the early symptoms of MERS-CoV infection, slow triage of suspected cases, and delays in implementing infection, prevention, and control measures.

As of August 30, 2021, the U.S. FDA has not Approved a MERS-CoV preventive vaccine. However, the FDA has Authorized a MERS-related diagnostic test.

There are active clinical trials focused on MERS-COV vaccine candidates listed on this Coronavirus Today page.

Aug 30, 2021 • 7:23 pm CDT

The World Health Organization (WHO) stated on August 27, 2021, 'it does not support the requirement of proof of COVID-19 vaccination to travel.'

However, depending on the risk assessment of the countries concerned, information about vaccination against COVID-19 may be used to reduce requirements for quarantine or testing upon arrival.

But this is not the primary purpose of the move towards digital documentation of COVID-19 status.

The WHO recently published a guidance document for countries and implementing partners on the technical requirements for issuing digital certificates for vaccination against COVDI-19.

The guidance is part of a series of planning documents on the digitalization of COVID-19 certificates.

The guidance will, amongst other things, Support Member states in adopting digital tools for documenting COVID-19 vaccination status for effective health care and proof of vaccination should it be needed for other purposes.

The minimum requirements for implementing digital documentation in countries around the world empower Member States the greatest possible flexibility to build a solution appropriate not just for their needs but the diverse needs of individuals around the world.

The WHO guidance was developed in collaboration with a multi-disciplinary group of experts to ensure that it will be useful to governments and implementing partners who have built or who are currently developing systems for issuing or verifying digital vaccination certificates.

The technical content of the WHO guidance has been made available to partner countries and economies that have developed or are in the process of developing national digital vaccination certificates to ensure that these digital certificate products will be interoperable. In addition, technical assistance will be provided to countries and implementing partners to align existing products to WHO specifications.

Aug 30, 2021 • 6:02 pm CDT

The European Centre for Disease Prevention and Control (ECDC), an agency of the European Union, publishes maps weekly in support of the coordinated approach to the restriction of free movement in response to the COVID-19 pandemic, as amended in June 2021.

The COVID-19 maps are based on data reported by the EU Member States to the European Surveillance System every Tuesday.

And, the total number of COVID-19 vaccine doses distributed to EU/EEA twenty-nine countries has exceeded 612 million.

Furthermore, at the request of Member States, data on the daily number of new reported COVID-19 cases and deaths by EU/EEA countries was published on August 30, 2021.

Aug 29, 2021 • 3:42 pm CDT

According to JPost reporting on August 29, 2021, Israel's Health Minister Nitzan Horowitz confirmed that the third COVID-19 vaccination is now available for anyone 12 years of age and older and who has received two previous inoculations for at least five months.

This new vaccination policy is effective immediately.

The joint COVID-19 vaccine task force of the Israel Pediatric Association and the Department of Pediatric Infectious Diseases published Frequently Asked Questions.

As of August 29th, the Israeli data dashboard indicates over 2 million people have already received a 3rd COVID-19 vaccination.

Furthermore, the dashboard reveals Israel has confirmed over 680 new serious COVID-19 cases daily for the past eight days.

Additionally, the Israeli Ministry of Health issued a press statement today 'informing the general public that anyone who came in contact with Dr. S. K., reflexologist, in his clinic at 22 Antwerp Street, Netanya, between August 14 through 24, 2021, is required to test for SARS-CoV-2 coronavirus and inform their primary care physician.

Furthermore, anyone who is not fully vaccinated (2-doses) or recovered from COVID-19 is required to enter immediate isolation and fill in the isolation self-report form on the Ministry of Health's website.

Aug 26, 2021 • 7:37 pm CDT
US FDA

The Texas Department of State Health Services (DSHS) issued a health advisory on August 26, 2021, regarding the improper use of ivermectin to treat or prevent COVID-19 infection by the public.

The DSHS recommends 'people take ivermectin only when prescribed by their healthcare provider and take it exactly as prescribed. This is because large doses of ivermectin can cause serious harm.'

In August 2021, the Texas Poison Center Network (TPCN) experienced a more than 150% increase in the number of calls received about ivermectin exposures compared with the previous month.

From January to August 24, 2021, the TPCN received a total of 159 Ivermectin exposure calls, more than triple the 48 calls received in all of 2020.

The largest number (64) occurred in August 2021.

More than half of the 2021 calls (87) were potential Ivermectin exposure taken in an attempt to treat or prevent COVID-19.

Most of the calls were about people experiencing mild symptoms, but for 33%, the patient was either on the way to a health care facility or was referred to a health care facility, suggesting more severe effects.

Since early July 2021, outpatient ivermectin dispensing has again begun to increase, rapidly reaching more than 88,000 prescriptions in the week ending August 13, 2021. This represents a 24-fold increase from the pre-pandemic baseline, says the U.S. CDC.

Ivermectin is not an anti-viral drug that can treat viral illnesses such as COVID-19. The U.S. FDA has not approved ivermectin for treating or preventing COVID-19.

Ivermectin is an antiparasitic drug that the U.S. FDA approves for topical treatment of head lice and skin conditions such as rosacea. It is also approved to treat parasitic worms (intestinal strongyloidiasis, onchocerciasis, and helminthiases) and scabies.

Some Ivermectin forms can be used to treat parasites in animals but are different than the forms for people and should only be used in animals.

The adverse effects of taking ivermectin may include skin rash, pruritis, nausea, diarrhea, stomach pain, facial or limb swelling. In addition, neurological effects such as dizziness, confusion, and seizures have also been documented.

Moreover, ivermectin can interact with other medications, such as blood thinners, leading to vomiting, low blood pressure, allergic reactions, dizziness, problems with balance, seizures, coma, and even death.

Aug 26, 2021 • 1:47 pm CDT

A new cross-sectional study published by the JAMA Network on August 17, 2021, found professional and college football games played during the COVID-19 pandemic found 'no association between higher county-level COVID-19 cases and hosting football games with limited in-person attendance.'

This study's conclusion is important as 'there is currently no evidence on whether limited in-person attendance of (outdoor) games is associated with COVID-19 case numbers on a county-level.'

A total of 528 games with in-person attendance (101 NFL; 427 NCAA) were included in this study. The matching algorithm returned 361 matching sets of counties.

The median (IQR) daily new COVID-19 cases in treatment group counties hosting games was 26.14 (10.77-50.25) cases per 100 000 residents on game day. The median IQR daily new COVID-19 cases in control group counties where no games were played was 24.11 (9.64-48.55) cases per 100 000 residents on game day.

The treatment effect size ranged from −5.17 to 4.72, with a mean (SD) of 1.21 (2.67) cases per 100 000 residents, within the 14-day period in all counties hosting the games and the daily treatment effect trend remained relatively steady during this period.

'These findings suggest that NFL and NCAA football games hosted with limited in-person attendance were not associated with substantial risk for increased local COVID-19 cases,' stated these researchers.

In addition, Michael A. Rubin, M.D., Ph.D., MS, wrote an Invited Commentary also published by the JAMA Network, stating 'the sensitivity analysis on the duration of the pretreatment and posttreatment periods demonstrated the robustness of their results, even when the posttreatment period was extended to 21 days.'

'While the message is encouraging, the interpretation of the results requires some caution.'

'Because the authors did not have access to exact attendance figures for the NCAA games, the representation of in-person attendance as a binary value prevented a more precise understanding of how the number (or concentration) of spectators may have influenced the outcome.'

'Additionally, other unmeasured variables not included in the model, such as other types of mass indoor or outdoor gatherings that may have occurred in treatment or control counties, could have biased the observed results toward the null.'

'Furthermore, many NFL and NCAA football stadiums are outdoor, open-air facilities, where aerosols are rapidly dispersed, limiting the relevance of these results to leagues such as the NBA and NHL that largely hold indoor events.'

However, it is worth noting that emerging SARS-CoV-2 virus variants have less predictable implications at this point in time and might lead to more disruptive interruptions in the future.

Note: This work was supported by awards from the National Science Foundation and a grant from the Gordon and Betty Moore Foundation, paid to Johns Hopkins University to support the work of the Society for Medical Decision Making COVID-19 Decision Modeling Initiative. The researchers disclosed relevant industry conflicts.

Aug 26, 2021 • 12:54 pm CDT
Unsplash

An observational study published in the journal Breastfeeding Medicine on August 24, 2021, found breast milk of lactating mothers vaccinated against COVID-19 contains a supply of SARS-CoV-2 virus antibodies that may help protect nursing infants from the illness.

According to this new research from the University of Florida, when babies are born, their immune systems are underdeveloped, making it hard for them to fight infections independently.

They are also often too young to respond adequately to certain types of vaccines, stated Josef Neu, M.D., one of the study’s co-authors and a professor in the UF College of Medicine’s department of pediatrics, division of neonatology, in a related press statement.

During this vulnerable period, breast milk allows nursing mothers to provide infants with “passive immunity,” Dr. Neu explained.

“Think of breast milk as a toolbox full of all the different tools that help prepare the infant for life."

"Vaccination adds another tool to the toolbox, one that has the potential to be especially good at preventing COVID-19 illness,” Neu said.

“The results of our study strongly suggest that vaccines can help protect both mom and baby, another compelling reason for pregnant or lactating women to get vaccinated.”

The study was conducted between December 2020 and March 2021. For the study, researchers recruited twenty-one lactating health care workers who had never contracted COVID-19.

With that in mind, the research team continues to explore how breast milk containing COVID-19 antibodies gained through vaccination protects babies who consume it.

“We would like to know if infants who consume breast milk containing these (SARS-CoV-2) antibodies develop their own protection against COVID-19,” commented Joseph Larkin III, Ph.D., senior author of the study and an associate professor in the UF/IFAS department of microbiology and cell science.

Unanswered questions aside, the researchers remain excited and encouraged by their initial results.

“In addition, we would also like to know more about the antibodies themselves, such as how long they are present in breast milk and how effective they are at neutralizing the coronavirus.”

The study is published in the journal Breastfeeding Medicine and was funded by the Children’s Miracle Network.

Aug 23, 2021 • 7:04 pm CDT

According to a study published in the journal Nature Medicine on August 19, 2021, healthcare provider videos syndicated on Facebook encouraging people to stay home were associated with a 3.5% decrease in county-level COVID-19 cases in the USA during Thanksgiving and Christmas 2020 holidays.

The first two primary outcomes were holiday travel and fraction leaving home, both measured using mobile phone location data of Facebook users.

The average distance traveled in high-intensity counties decreased by −0.993 percentage points the 3 days before each holiday compared to low-intensity counties.

And the fraction of people who left home on holiday was not significantly affected.

The third primary outcome was COVID-19 infections recorded at the zip code level in the 2-week period starting five days after the holidays.

Infections declined by 3.5% (adjusted 95% CI: −6.2%, −0.7%; P = 0.013) in intervention compared to control zip codes.

'We found a significant effect on new COVID-19 infections reported by health authorities 5–19 days after the Facebook ad campaigns. However, these effects might be underestimated because the treatment and control zip codes are very close to each other, and the reductions in infection in treatment zip codes might also have led to a decrease in infections in neighboring places.'

Furthermore, despite the study's limitations, our findings provide renewed evidence that clinicians can be an effective channel to communicate life-saving information at scale through social media,' concluded these researchers.

Note: Facebook provided the credits used to show the ads. The study authors declare no competing financial interests.

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Aug 22, 2021 • 6:08 am CDT

The Israeli Ministry of Health's Director-General, Prof. Nachman Ash, approved the recommendation by the Consultant Committee for the Vaccine for Coronavirus, the Epidemics Management Team and the Monitoring on August 19, 2021, to administer a third mRNA COVID-19 vaccine dose to the broader Israel population.

The press statement says 'only after 5 months have passed since the second vaccine dose, individuals aged 40 and older, healthcare staff, teaching staff, caregivers of older adults and pregnant women of all ages can receive a third dose.

Furthermore, the Director-General issued a notice to the directors-general of the HMOs accordingly: Effective today (Aug. 20th), those aged 40 and older may contact their HMO to schedule an appointment for the third vaccine dose.

Since the third COVID-19 vaccination program for seniors was announced on July 29, 2021, over 1,377,00 people have been vaccinated, according to the Israel Ministry of Health data dashboard, as of August 22, 2021.

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Aug 19, 2021 • 2:36 pm CDT

Haaretz News reported today Israel's vaccination committee recommends the Health Ministry expand the third COVID vaccination program to include Israelis aged 40 and up and teachers.

According to Minister Nitzan Horowitz's post on Twitter, the Health Ministry is expected to accept the recommendation.

As of August 18, 2021, Israel has administered over 1.2 million third-doses of the Pfizer-BioNTech COVID-19 (Comirnaty) vaccine since the expanded vaccination program launch in late July 2021.

Yesterday, Health Ministry Director-General Prof. Nachman Ash signed a directive that would allow vaccinating students against the SARS-CoV-2 coronavirus during school hours, reported YnetNews.

These actions are related to the ongoing COVID-19 pandemic in Israel.

On August 18th, the Health Ministry's dashboard revealed 599 individuals were newly classified as 'serious COVID-19' patients. This data compares with one month ago when the dashboard showed only 67 serious COVID-19 patients one month ago.

Aug 17, 2021 • 11:44 am CDT

The European Medicines Agency (EMA) announced it had started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalized adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation.

RoActemra is considered a potential treatment for COVID-19 because of its ability to block the action of interleukin-6, a substance produced by the body’s immune system in response to inflammation, which plays an important role in COVID-19.

RoActemra is a medicine used to treat rheumatoid arthritis and contains the active substance tocilizumab.

RoActemra can also be used in adults and certain children to treat life-threatening cytokine release syndrome, a condition that can cause nausea, vomiting, pain, and low blood pressure.

It was first authorized in the EU in 2009.

The EMA’s human medicines committee confirmed it would carry out an accelerated assessment of the data submitted in the application, including results from four large randomized studies in patients hospitalized with severe COVID-19, to decide whether the extension of indication should be authorized.

The EMA stated in a press release issued on August 16, 2021, it will communicate the outcome of its evaluation, which is expected by mid-October 2021 unless supplementary information is needed.

Aug 16, 2021 • 12:12 pm CDT

A non-peer-reviewed study published on August 7, 2021, aimed to determine antibody (Ab) titers three months after the second dose of the BNT162b2 (Comirnaty) vaccine and to explore clinical variables predicting these titers in Japan.

In the age-adjusted analysis of the 384 study participants, the leading risk factors for lower Ab titers were age and smoking.

Moreover, Ab titers were significantly lower in current smokers than in ex-smokers.

In conclusion, these researchers stated, 'The most important factors associated with low Ab titers were age and smoking habit.'

Note: The Ethics Committee approved this study of the National Hospital Organization Utsunomiya National Hospital (No. 03-01, April 19, 2021). No conflicts of interest were disclosed.

Aug 14, 2021 • 11:52 am CDT

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued an updated Coronavirus vaccine - a weekly summary of Yellow Card reporting on August 13, 2021.

The MHRA states, 'Vaccination is the single most effective way to reduce deaths and severe illness from COVID-19.'

A national immunization campaign has been underway since early December 2020, with three COVID-19 vaccines, Pfizer-BioNTech (Comirnaty), COVID-19 Vaccine AstraZeneca, and COVID-19 Vaccine Moderna (SpikeVax), currently being used in the UK.

The overall Yellow Card reporting rate for these vaccines is around 3 to 7 Yellow Cards per 1,000 doses administered.

As of August 4, 2021, for the UK, 101,483 Yellow Cards have been reported for the Pfizer-BioNTech vaccine, 226,959 have been reported for the COVID-19 Vaccine AstraZeneca, and 12,569 for the COVID-19 Vaccine Moderna.

It is important to note that Yellow Card data cannot be used to derive side effect rates or compare the safety profile of COVID-19 vaccinations as many factors can influence ADR reporting, says the MHRA.

For all COVID-19 vaccines, the overwhelming majority of reports relate to injection-site reactions (sore arm, for example) and generalized symptoms such as ‘flu-like illness, headache, chills, fatigue, nausea (feeling sick), fever, dizziness, weakness, aching muscles, and rapid heartbeat.

Generally, these happen shortly after the vaccination and are not associated with more serious or lasting illnesses.

The reported suspected side effects are broadly similar across age groups, although, as was seen in clinical trials. As is usually seen with other vaccines, they may be reported more frequently in younger adults, says the MHRA.

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