by KS
MODERNA VACCINE GETS FULL APPROVAL :United States
For those who withheld trust for one particular COVID-19 due to its emergency use authorization, that decision may change after a major announcement.
On Jan. 31, the U.S. Food and Drug Administration (FDA) approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older.
Key points:
• Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval.
• Moderna COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since Dec. 18, 2020.
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” said Acting FDA Commissioner Janet Woodcock, M.D.
“While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.
Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine.
It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine.
“The FDA’s medical and scientific experts conducted a thorough evaluation of the scientific data and information included in the application pertaining to the safety, effectiveness, and manufacturing quality of Spikevax. This includes the agency’s independent verification of analyses submitted by the company, our own analyses of the data, along with a detailed assessment of the manufacturing processes, test methods and manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.”
FRIGHTENING LIGHTNING : WORLD
The World Meteorological Organization (WMO) has established two new world records for so-called megaflashes of lightning, in notorious hotspots in North and South America.
In the southern United States, WMO’s Committee on Weather and Climate Extremes on Feb. 1, officially recognized a single flash that covered a horizontal distance of 768 ± 8 km (477.2 ± 5 miles) on April 29, 2020. This happening between the states of Texas, Louisiana, and Mississippi.
“This is equivalent to the distance between New York City and Columbus, Ohio in the United States or between London and the German city of Hamburg,” said WMO in a press release.
The other record announced was for the greatest duration for a single lightning flash – of 17.102 ± 0.002 seconds from the flash – that developed continuously through a thunderstorm over Uruguay and northern Argentina, on June 18, 2020.
The new record for the longest detected megaflash distance is 60 kilometers more than the previous record, which was recorded with a distance of 709 ± 8 km (440.6 ± 5 mi) across parts of southern Brazil on Oct. 31, 2018.
Both the previous and new record used the same maximum great circle distance methodology to measure flash extent, said WHO, meaning the shortest measurable distance between two points on a sphere.
The now runner up for the longest duration megaflash record, stood at 16.73 seconds which was derived from a flash that developed continuously over northern Argentina on March 4, 2019 – that’s 0.37 seconds shorter than the new record announced on Feb. 1.
The findings were published in the Bulletin of the American Meteorological Society.
Other previously accepted WMO lightning extremes have been far more deadly, than spectacular: in Zimbabwe, in 1975, 21 people were killed by a single flash of lightning as they huddled for safety in a hut.
And the grim record for fatalities caused by an indirect lightning strike, saw 469 people killed in Dronka, Egypt when lightning struck a set of oil tanks, causing burning oil to flood the town in 1994.
The previous assessments that established the flash duration and extent records, used data collected by ground-based Lightning Mapping Array (LMA) networks.
Many lightning scientists acknowledged that there are upper limits for the scale of lightning that could be observed by any existing LMA, and that identifying megaflashes beyond these extremes, would require a lightning mapping technology with a larger observation domain.
FRAUDSTERS TAKEN DOWN: EUROPE
Judicial and law enforcement authorities in Bulgaria, supported by Europol and Eurojust, have taken down a network of online investment fraudsters involved in money laundering. On the action day on Jan. 26, officers from the Bulgarian National Police arrested one suspect for defrauding mainly German and Greek investors of at least EUR 10 million. During the action day, a total of 24 locations were searched, while officers interrogated 66 witnesses in Sofia and Burgas. Furthermore, a variety of electronic equipment, financial information and recordings were seized.
Europol deployed two experts on the ground in Bulgaria to facilitate the information exchange and provide real-time operational analysis and technical expertise. Eurojust coordinated the joint action day and provided cross-border judicial support. The national authorities deployed around one hundred officers and prosecutors during the action day.
The scam was exposed after complaints were made by German and Greek investors who had lost all of the deposits they had invested in the online scam. The organized crime group responsible had set up websites and call centers that appeared to be legitimate but were actually fraudulent.
The fraudulent activity was conducted by two call centers. While acting as financial consultants, call operators speaking German, Greek, English and Spanish contacted potential investors with promises of significant profits. As a result, several hundred victims made substantial investments but subsequently lost all of their money.
In 2019, Bulgarian authorities started investigations and Eurojust set up a joint investigation team (JIT) between Bulgaria, Germany, Greece, Serbia and Europol. Following five coordination meetings with Europol and Eurojust, the JIT members were able to identify the two fraudulent call centers in Bulgaria. The Bulgarian police, supported by the Serbian* authorities, dismantled both call centers on the action day.
In 2020, a similar modus operandi was used in another case and a coordinated action day led to the dismantling of two other call centers.
