Coronavirus Breaking News

The European Medicines Agency (EMA) reported today Austrian's national competent authority had suspended using a batch of COVID-19 Vaccine AstraZeneca (batch number ABV5300) after a person was diagnosed with multiple thrombosis and died 10 days after vaccination. Another person was hospitalized with pulmonary embolism after being vaccinated. The latter is now recovering.

As of March 9, 2021, two other reports of thromboembolic event cases had been received by the EMA for this vaccine batch.

Overall, 22 cases of thromboembolic events had been reported among the 3 million people vaccinated with COVID-19 Vaccine AstraZeneca in the European Economic Area during 2021.

However, there is currently no indication that vaccination with the AstraZeneca COVID-19 vaccine has caused these conditions, which are not listed as side effects with this vaccine. Although a quality defect is considered unlikely at this stage, the batch quality is being investigated, stated the EMA in a press release.

Batch ABV5300 was delivered to 17 EU countries and comprised 1 million vaccine doses. Some EU countries have also subsequently suspended this batch as a precautionary measure, while a full investigation is ongoing. The EMA commented the 'information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population.

And the EMA will continue its assessment of any potential issue with the batch as well as its review of thromboembolic events and related conditions.'

The AstraZeneca COVID-19 vaccine, formerly known as ChAdOx1 nCoV-19, is made from a virus (ChAdOx1), a weakened version of a common cold virus. Genetic material has been added to the ChAdOx1 construct, which is used to make proteins from the SARS-CoV-2 coronavirus called Spike glycoprotein.

Researchers from NYU Grossman School of Medicine found people previously infected with the SARS-CoV-2 coronavirus may produce levels of antibodies against COVID-19 after one dose of the Pfizer–BioNTech COVID-19 vaccine that is equal to or higher than people not previously infected have after two vaccine doses.

In the limited study announced on March 9, 2021, people that previously had COVID-19 infection and who received a single dose of mRNA vaccine produced high levels of “neutralizing” antibodies—those capable of defending cells from the virus and of blocking its biological effects at 6 to 14 days after vaccination.

“Our findings support a hypothesis that SARS-CoV-2–experienced people may require only a single dose of mRNA vaccine,” commented Mark J. Mulligan, MD, director of the Division of Infectious Diseases and Immunology and director of the Vaccine Center, in a press release.

“That said, our results would need to be borne out by larger studies before they influenced current policy, which is that patients receive the evidence-based, two-shot regimen."

Researchers say vaccines safely mimic actual infections, which teaches the immune system to be ready for a future encounter. The Pfizer vaccine is based on RNA, or ribonucleic acid, which serves as the primary genetic material instead of DNA for the pandemic coronavirus. The vaccine contains viral mRNA encoding the “spike proteins” used by SARS-CoV-2 to attach to proteins on human cell surfaces, which invade the cells in which it multiplies.

Including the spikes in vaccines has made proteins required for viral ability to infect visible to the human immune system, say the study authors. Once injected into the arm muscle, the spike protein is made. It triggers the production of antibodies, immune proteins that specifically glom onto this viral target protein, disabling it and tagging it for removal from the body.

The Pfizer-BioNTech COVID-19 vaccine was issued the first U.S. Food and Drug Administration (FDA) emergency use authorization for a vaccine to prevent COVID-19 in individuals 16 years of age and older on December 11, 2020. However, the experimental Pfizer-BioNTech COVID-19 vaccine has not been Approved or Licensed by the U.S. FDA.

The Annal of Internal Medicine published the fifth update alert on March 9, 2021, for a living rapid review on the use of masks for the prevention of respiratory virus infections, including SARS-CoV-2, in health care and community settings.

This Alert found the strength of evidence for any mask use versus nonuse in community settings remains low. Other strength-of-evidence ratings related to mask use in community settings were unchanged because of no new evidence.

The comparison of N95 mask only use versus surgical mask use favored the N95, but the difference was not statistically significant (odds ratio, 0.60 [CI, 0.31 to 1.15]). Based on disclosed study limitations and because of inconsistent results across studies, evidence for N95 versus surgical mask use and other comparisons involving mask use and risk for SARS-CoV-2 infection in health care settings remains insufficient.

Furthermore, as with prior updates, there were no new studies on the effectiveness and safety of mask reuse or extended use.

The U.S. CDC announced on March 8, 2021, if you’ve been fully vaccinated with an experimental COVID-19 vaccine, you should still take steps to protect yourself and others in many situations, like wearing a mask, staying at least 6 feet apart from others, and avoiding crowds and poorly ventilated spaces.

Finland-based Rokote Laboratories Finland Ltd. announced it is working to introduce a nasal spray vaccine against COVID. The vaccine candidate uses gene transfer technology developed at the University of Eastern Finland by Academy Professor Seppo Ylä-Herttuala's research group.

The vaccine uses a safe adenovirus carrier that contains a cloned DNA strand, which causes nasopharyngeal cells to produce the virus protein, which, in turn, produces a response to the vaccine. There is no actual SARS-CoV-2 virus in the vaccine.

"Even if we were able to vaccinate the entire population, at least people in medical risk groups will still need new vaccines against new variants in the upcoming years," stated Professor of Virology Kalle Saksela from the University of Helsinki.

According to a press statement issued on March 8, 2021, the technology has already been successfully used in several clinical trials using gene therapy to treat cardiovascular diseases and cancer. Preliminary results show that the vaccine has performed well in animal studies, and clinical testing in humans will start within a few months.

Nasal delivery was chosen as the new vaccine's method of administration because the virus is also naturally transmitted through the airways.

"Vaccines injected intramuscularly produce IgG antibodies in the bloodstream, but nasal vaccines also produce an IgA response that protects mucous membranes. We assume that this can also prevent those who have received the vaccine from transmitting the virus," commented Academy Professor Seppo Ylä-Herttuala from the University of Eastern Finland.

The University of Eastern Finland is an international, participatory, and inclusive scientific community.

The Lancet published a commentary on March 6, 2021, which highlighted the positive impact of the single-dose Oxford–AstraZeneca COVID-19 vaccine followed by a 12-week booster.

Overall, this study provides evidence that a single dose of the ChAdOx1 nCoV-19 vaccine is highly efficacious in the 90 days after vaccination. And that a longer prime-boost interval results in higher vaccine efficacy. Furthermore, the protection against symptomatic COVID-19 is maintained despite a longer dosing interval.

In exploratory analyses, vaccine efficacy after a single standard dose was 76% from day 22 to day 90, and antibody levels were maintained during this period with minimal waning. Supporting a longer-interval immunization strategy, vaccine efficacy was significantly higher at 81% after two standard doses are given at an interval of 12 weeks or longer, compared with 55% when given less than 6 weeks apart.

This analysis offers supporting evidence for the United Kingdom's policies of extending the AstraZeneca COVID-19 vaccine dosing interval to 12 weeks and for rapid mass-immunization campaigns worldwide.

The US Centers for Disease Control and Prevention (CDC) published its weekly COVID-19 report today, showing various trends on the decline. This good news from the CDC on March 5, 2021, includes declines in cases, hospitalization, and mortality related to COVID-19 in the USA.

In recent weeks during 2021, there has been an overall decline of 43.1% of the COVID-19 fatality 7-day moving average since January 13th. The current 7-day average of related deaths is a 6.7% decrease from the previous 7-day average of 2,060 daily deaths.

Hospital admissions of patients with confirmed COVID-19 decreased 67% from the national 7-day average peak on January 9, 2021, to a 7-day average of 5,490 admissions on March 2, 2021.

The percent of COVID-19 RT-PCR tests that were positive continued to decline as well. The 7-day average of percent positivity from tests is now 4.5%. In January 2021, the SARS-CoV-2 virus positivity rate exceeded 10%.

The one metric that significantly increased is the number of COVID-19 vaccinations, which began in the USA on December 14, 2020. As of March 4th, 82.6 million vaccine doses have been administered.

The CDC says, 'As we enter spring, we need to stay focused on reducing spread in our communities. This means we need to continue to practice proven prevention strategies, including wearing a well-fitted mask, staying six feet apart from people we don’t live with, avoiding gatherings, washing hands often, staying home when sick, and getting vaccinated when the vaccine is available to you.'

South Korea-based GC Pharma announced that it would support Moderna Inc. and the Republic of Korea's government to distribute 40 million doses of COVID-19 Vaccine Moderna.

Under the terms of its agreement with Moderna, GC pharma is responsible for local regulatory activities. Under the terms of its agreement with the Korean government, GC Pharma, with the Korean government authorities' support, is responsible for distribution activities in South Korea.

“We are proud to be partnering with the government and Moderna to support the distribution of crucial vaccines to the South Korean public,” said EC Huh, Ph.D., President of GC Pharma, in a press statement. “At GC pharma, with using our industry know-how, we are also exploring multiple ways to specifically help those impacted by COVID-19 and ensure preparedness for future public health emergencies.”

The Korea Diseases Control and Prevention Agency previously announced that it would import 40 million doses of COVID-19 Vaccine Moderna from the second quarter of 2021.

Headquartered in Yongin, South Korea, GC Pharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.