Coronavirus Breaking News

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

May 19, 2021 • 11:08 am CDT

The U.S. Food and Drug Administration (FDA) announced today it is reminding the public and health care providers that results from currently authorized SARS-CoV-2 antibody tests should not be used to evaluate a person’s level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination.

While a positive antibody test result can be used to help identify people who may have had prior SARS-CoV-2 infections, more research is needed in people who have received a COVID-19 vaccination.

Currently authorized SARS-CoV-2 antibody tests have not been evaluated to assess the level of protection provided by an immune response to COVID-19 vaccination. If antibody test results are interpreted incorrectly, there is a potential risk that people may take fewer precautions against SARS-CoV-2 exposure.

The FDA says 'Taking fewer steps to protect against SARS-CoV-2 can increase their risk of SARS-CoV-2 infection and may result in the increased spread of the SARS-CoV-2 beta coronavirus.'

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May 19, 2021 • 9:50 am CDT

The European Commission (EC)'s draft plan to reopen Europe for non-essential travel appears ready to exclude a leading COVID-19 vaccine, the Sputnik V Vaccine.

According to the Washington Post on May 19, 2021, EC spokesman Christian Wigand stated, “Today, E.U. ambassadors agreed to update the approach to travel from outside the European Union (EU)." The EC “now recommends that member states ease some restrictions, in particular for those vaccinated with an E.U.-authorized vaccine.”

The European Medicines Agency (EMA) has issued authorizations for the Comirnaty (Pfizer-BioNTech), COVID-19 Vaccine Moderna, Vaxzevria (AstraZeneca), and COVID-19 Vaccine Janssen as of May 19, 2021.

This EC statement indicates international travel plans of residents from over 60 counties would be impacted that are administering the Sputnik V or the new Sputnik Light vaccines.

However, this proposed EC guidance would not be binding, meaning that some EU countries could choose to be more or less restrictive regarding which COVID-19 vaccines are acceptable.

And as of May 18, 2021, both the EMA and World Health Organization indicate they are 'reviewing data regarding the Sputnik V vaccine' without a confirmed approval date committed.

Additionally, a future administrative issue for European travelers could be the EC's proposed vaccine passport.

On March 17, 2021, the EC presented a proposal to create a Digital Green Certificate to facilitate the safe free movement of citizens within the EU during the COVID-19 pandemic. When traveling abroad, every EU citizen or third-country national legally staying or residing in the EU, who holds a Digital Green Certificate, would be exempted from free movement restrictions in the same way as citizens from the visited EC Member State.

Currently, the US government has Authorized three experimental COVID-19 vaccines but has not announced a COVID-19 vaccine passport program. Two leading travel destination states, Florida and Texas, have already banned requiring vaccine passport requirements.

May 18, 2021 • 3:59 pm CDT

The Canadian National Advisory Committee on Immunization (NACI) issued new advice on May 18, 2021, to the federal, provincial, and territorial governments on the recommended use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 15 years of age.

The NACI recommends that a complete series with the Pfizer-BioNTech COVID-19 vaccine should be offered to individuals in this population.

Previously, Health Canada authorized the use of the Pfizer-BioNTech COVID-19 mRNA vaccine in adolescents 12 to 15 years of age on May 5, 2021, following a Phase 3 clinical trial this population.

"Although the risk of hospitalization, admission to ICU, and death associated with COVID-19 is infrequent in this age group, we have seen that adolescents can still experience severe illness," stated Dr. Caroline Quach-Thanh, NACI Chair, in a related press statement.

"The availability of this vaccine for teenagers in Canada will allow them to resume the activities that are so central to their health and well-being, including in-person schooling, events with friends and family, and extracurricular activities, in accordance with local public health measures."

The safety and effectiveness of the vaccine in adolescents will continue to be monitored in clinical trial participants and those receiving the vaccine through public health programs. NACI will closely monitor evolving evidence and update its recommendations if needed.

To see the full update, please see Recommendation on the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents 12 to 18 years of age.

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May 17, 2021 • 8:35 am CDT

India's Minister of Defence, Shri Rajnath Singh, and the Minister of Health and Family Welfare, Dr. Harsh Vardhan, today jointly launched the new COVID drug 2-DG.

The anti-COVID-19 therapeutic application of the drug 2-deoxy-D-glucose (2-DG) has been developed by the Institute of Nuclear Medicine and Allied Sciences, a Defence Research and Development lab Organisation, along with Dr. Reddy’s Laboratories, located in Hyderabad.

Dr. Vardhan remarked in a press statement issued on May 17, 2021, 'that today is a historic day in our fight against COVID and congratulated the scientific community and DRDO for their patience and perseverance in developing the first indigenous medicine.'

'He said that the drug has the potential to become a game-changer in our response against COVID pandemic as it reduces the dependence of patients on oxygen administration and has the potential of getting absorbed differentially and in a selected manner.'

'In the COVID infected cells, it inhibits virus synthesis and energy production for the process.'

Dr. Vardhan further stated 'that the drug will go to the selective cells and prevent the synthesis of virus and reduce recovery time.'

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May 16, 2021 • 6:31 am CDT

The US Centers for Disease Control and Prevention (CDC) issued a new Operational Strategy for K-12 Schools late on May 15, 2021.

The CDC recommends schools continue to use the current COVID-19 prevention strategies for the 2020-2021 school year, including universal and correct use of masks and physical distancing should be maximized to the greatest extent possible.

Masks should be worn at all times, by all people in school facilities, with certain exceptions for certain people, or for certain settings or activities, such as while eating or drinking. Masks should be required in all classroom and non-classroom settings, including hallways, school offices, restrooms, gyms, auditoriums, etc.

And, testing to identify individuals with SARS-CoV-2 infection provides additional layers of COVID-19 protection in schools, stated the CDC.

'All prevention strategies provide some level of protection, and layered strategies implemented at the same time provide the greatest level of protection.'

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May 14, 2021 • 12:42 pm CDT

The US Centers for Disease Control and Prevention (CDC) reported today the current 7-day moving average of daily new COVID-19 cases (35,442) decreased 23.6% compared with the previous 7-day moving average.

Compared with the highest peak on January 8, 2021, the current 7-day average decreased 85.8%.

Since the COVID-19 pandemic began in late 2019, a total of 32,643,851 COVID-19 cases have been reported in the USA as of May 12th.

Furthermore, the current 7-day average hospital admission rate of 12.4% decrease from April 28–May 4th. COVID-19 related hospitalizations have been consistently decreasing since April 19, 2021.

Children ages 5-17 years have the lowest hospitalization rate of all age groups.

And the current 7-day moving average of new deaths (592) decreased 10.3% compared with the previous 7-day moving average, says the CDC.

May 13, 2021 • 7:55 am CDT

The Food and Drug Authority (FDA) of the Republic of Angola confirmed on May 12, 2021, the registration of the single-component Sputnik Light vaccine. The FDA granted Sputnik V an emergency use authorization.

The Russian Direct Investment Fund (RDIF) stated in a press release 'the Sputnik Light vaccine is the first component (recombinant human adenovirus 26 serotype (rAd26)) of the Sputnik V vaccine, which was authorized in Angola in March 2021. The RDIF says the effectiveness of the single-component vaccine "Sputnik Light" is 79.4% from the 28th day after vaccination.

On May 6, 2021, the Ministry of Health of the Russian Federation, the National Research Center for Epidemiology and Microbiology, and the RDIF announced the registration of the Sputnik Light vaccine.

Angola is a Southern African nation of about 31 million residents that primarily speaks Portuguese. With tropical Atlantic beaches to the west, located near the Sub-Saharan desert, Angola is administratively divided into 18 provinces and 163 municipalities.

In Angola, the US Embassy says most COVID-19 cases are in the capital city of Luanda, but COVID-19 has been confirmed throughout the provinces.  Please visit the Angolan COVID-19 Commission’s website for the most up-to-date case numbers.

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May 12, 2021 • 7:25 am CDT

The Moscow Times reported a poll by the Levada Center reported 10% of respondents indicated they have already been vaccinated. On May 12, 2021, the poll found 56% of Russians are not afraid of contracting the SARS-CoV-2 coronavirus, and 42% are afraid.

At its current vaccination pace, Russia is on track to vaccinate 70% of its population by February 2023, wrote the Moscow Times.

The Sputnik V vaccine was Approved for use in Russia during August 2020. Currently, Sputnik V is Authorized in about 64 countries.

The Levada Center stated these figures have not changed since February 2021. Levada conducted the new survey among 1,614 respondents from 50 Russian Federation regions between April 22-April 28, 2021.

May 11, 2021 • 6:54 am CDT

The U.S. Food and Drug Administration (FDA) announced the expansion of the Emergency Use Authorization (EUA) for the mRNA Phizer-BioNTech COVID-19 Vaccine (Comrinaty) to include adolescents 12 through 15 years of age. This EUA was originally issued on December 11, 2020, for administration in individuals 16 years of age and older.

Acting FDA Commissioner Janet Woodcock, M.D., said in a press statement issued on May 10, 2021, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

From March 1, 2020, through April 30, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the US Centers for Disease Control and Prevention.

However, children and adolescents generally have very mild COVID-19 disease course as compared to adults.

The available safety data to support the EUA in adolescents down to 12 years of age, including 2,260 participants ages 12 through 15, enrolled in an ongoing randomized, placebo-controlled clinical trial in the United States. Of these, 1,131 adolescent participants received the vaccine, and 1,129 received a saline placebo.

More than half of the participants were followed for safety for at least two months following the second dose.

The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.

Except for pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so vaccination providers and recipients need to expect that there may be some side effects after either dose, but even more so after the second dose. The side effects in adolescents were consistent with those reported in clinical trial participants 16 years of age and older.

It is important to note that as a general matter, while some individuals experience side effects following any vaccination, not every individual’s experience will be the same, and some people may not experience side effects.

The EUA amendment was issued to Pfizer Inc. The issuance of an EUA is not an FDA Approval (licensure) of a vaccine.

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May 10, 2021 • 8:24 pm CDT

The use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, does not lead to higher rates of death or severe disease in patients who are hospitalized with COVID-19, according to a new observational study of more than 78,000 people in the United Kingdom published in The Lancet Rheumatology journal on May 7, 2021.

NSAIDs are common treatments for acute pain and rheumatological diseases such as rheumatoid arthritis and osteoarthrosis.

Early in the COVID-19 pandemic, there was a clinical debate on whether the use of such drugs increased the severity of COVID-19.

These researchers concluded the study by saying 'NSAID use is not associated with higher mortality or increased severity of COVID-19. Therefore, policymakers should consider reviewing issued advice around NSAID prescribing and COVID-19 severity.'

Prof Ewen Harrison, of the University of Edinburgh and lead author of the study, said, We now have clear evidence that NSAIDs are safe to use in patients with COVID-19, which should provide reassurance to both clinicians and patients that they can continue to be used in the same way as before the pandemic began."

May 10, 2021 • 6:18 pm CDT

The Annals of Internal Medicine published a new study on May 11, 2021, In-Hospital Mortality in a Cohort of Hospitalized Pregnant and Nonpregnant Patients With COVID-19.

These researchers stated, 'Overall and within multiple subgroups, we found a substantially lower rate of in-hospital mortality in pregnant patients than nonpregnant patients hospitalized with COVID-19 and viral pneumonia.'

This retrospective cohort study of patients in the Premier Healthcare Database, an all-payer data repository that captures 20% of U.S. hospitalizations, included female inpatients aged 15 to 45 years hospitalized from April to November 2020 with COVID-19.

In-hospital death occurred in 0.8% (n = 9) of pregnant patients and 3.5% (n = 340) of nonpregnant patients hospitalized with COVID-19 and viral pneumonia.

The median time from admission to death was 18 days for pregnant patients and 12 days for nonpregnant patients.

Among the subgroup of patients admitted to an intensive care unit, in-hospital mortality was 3.5% (9 of 255) in pregnant patients and 14.9% (283 of 1898) in nonpregnant patients. Among those who received mechanical ventilation, in-hospital death occurred in 8.6% (9 of 105) of pregnant patients and 31.4% (294 of 937) of nonpregnant patients.

A strength of this study is the use of a large database, including patient discharge data from 853 hospitals. It is hospital-based, providing a clearly defined population without the biases of registry-based studies.

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May 10, 2021 • 7:25 am CDT

The Drugs Controller General of India (DCGI) approved on May 8, 2021, the application of the drug 2-deoxy-D-glucose (2-DG) developed by the Institute of Nuclear Medicine and Allied Sciences, a lab of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories.

Clinical trial results have shown that this molecule helps in the faster recovery of hospitalized patients and reduces supplemental oxygen dependence. A higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in COVID patients.

In Phase-II trials conducted from May to October 2020, 2-DG was found safe in COVID-19 patients and showed significant improvement in their recovery. A significantly favorable trend (2.5 days difference) was seen in terms of the median time to achieve normalization of specific vital signs parameters compared to SoC.

Based on successful results, DCGI further permitted the Phase-III clinical trials in November 2020.

2-DG comes in powder form in a sachet, taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. 2-DG selective accumulation in virally infected cells makes this drug unique.

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May 9, 2021 • 10:13 am CDT

The U.S. CDC confirmed on May 7, 2021, the principal mode by which people are infected with the SARS-CoV-2 beta coronavirus that causes COVID-19 is through exposure to respiratory fluids carrying infectious virus.

Exposure occurs in three principal ways: (1) inhalation of very fine respiratory droplets and aerosol particles, (2) deposition of respiratory droplets and particles on exposed mucous membranes in the mouth, nose, or eye by direct splashes and sprays, and (3) touching mucous membranes with hands that have been soiled either directly by virus-containing respiratory fluids or indirectly by touching surfaces with the coronavirus on them.

People release respiratory fluids during exhalation, such as quiet breathing, speaking, singing, exercise, coughing, sneezing in the form of droplets across a spectrum of sizes. These droplets carry viruses and transmit infection.

Once infectious droplets and particles are exhaled, they move outward from the source. The risk for infection decreases with increasing distance from the source and increasing time after exhalation, says the CDC.

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May 8, 2021 • 1:24 pm CDT

The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) met on May 3, 2021, reviewing safety signals related to COVID-19 vaccines.

The EMA authorizes four COVID-19 vaccines for use in the EU: Comirnaty, COVID-19 Vaccine Moderna, Vaxzevria (previously COVID-19 Vaccine AstraZeneca), and COVID-19 Vaccine Janssen.

On May 7, 2021, PRAC stated, 'the evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.' These risks are identified on this EMA webpage.

Separately, the World Health Organization (WHO) announced on May 7, 2021, the Sinopharm COVID-19 vaccine had been listed for emergency use.

WHO’s Emergency Use Listing is a prerequisite for the COVAX Facility vaccine supply. It also empowers countries worldwide to expedite their own regulatory approval to import and administer Listed COVID-19 vaccines.

May 7, 2021 • 1:08 pm CDT

According to US Centers for Disease Control and Prevention (CDC) reporting today, the current 7-day moving average of daily new cases (45,817) decreased 13.2% compared with the previous 7-day moving average.

Compared with the highest peak on January 8, 2021, the current 7-day average decreased 81.6%.

Throughout the sixteen-month COVID-19 pandemic, a total of 32,356,034 cases have been reported in the USA as of May 5, 2021.

Three COVID-19 vaccines are currently authorized and recommended for use in the USA, including the one-dose Johnson & Johnson - Janssen vaccine and the two-dose Pfizer BioNTech and Moderna vaccines. All three vaccines are safe, effective, and reduce your risk of severe illness, says the CDC.

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