The coronavirus disease COVID-19 is currently reaching pandemic levels in various countries.
National Center for Health Statistics (NCHS) Mortality Surveillance data available on December 10, 2020, found 14.3% of the deaths occurring during the week ending December 5th (week #49), were due to pneumonia, influenza, and COVID-19 (PIC).
The current increase in PIC mortality is due primarily to COVID-19, and not influenza, says the U.S. CDC.
Governor Greg Abbott announced that the State of Texas will participate in the Pharmacy Partnership for Long-Term Care Program to vaccinate residents and staff of long-term care facilities against COVID-19. The experimental vaccine (BNT162b2) is included in this program and will be provided to pharmacies in Texas during the week of December 21, 2020, and the program will begin December 28, 2020.
Governor Abbott said in a press statement issued on December 11, 2020: "I thank the U.S. CDC for offering this program free of charge to these facilities."
The British firm AstraZeneca has accepted a proposal from the Russian Direct Investment Fund (RDIF) and the N.F. Gamaleya Research Center said it and will begin clinical trials of its COVID-19 vaccine candidate in combination with the Sputnik V vaccine's adenoviral vector of the 26th serotype by the end of 2020. Among the leading vaccines against coronavirus at the moment, only Sputnik V has the technology of two different vectors.
The scheme using two different adenoviral vectors for primary and secondary immunization, which is a unique and fundamental development of specialists from the N.N. N.F. Gamalea, allows you to avoid the immunity to the first vector, which forms after the first immunization, and thereby increase the effectiveness of the second injection and form long-term immunity.
Kirill Dmitriev, CEO of the RDIF, commented in a press release: 'AstraZeneca's decision to conduct a study using one of the two vectors of the Sputnik V vaccine is an important step towards joining forces in the fight against the pandemic.'
Sanofi and GSK announce a delay in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in the elderly. Companies stated in a December 11, 2020, press release, they plan a Phase 2b study with an improved antigen formulation.
If data are positive, a global Phase 3 study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.
Roger Connor, President of GSK Vaccines added: “The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile. It is also clear that multiple vaccines will be needed to contain the pandemic."
"Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”
As of December 9, 2020, the U.S. FDA has authorized 298 coronavirus diagnostic tests, which include 229 molecular tests, 61 antibody tests, and 8 antigen tests during 2020. The state of California leads the USA with completed tests with 21,711,731 coronavirus tests performed, followed by New York (19,384,042), Florida (14,811,403), and Texas (12,539,677).
In total, the USA has confirmed over 207 million coronavirus tests this year.
INOVIO and Advaccine Biopharmaceuticals Suzhou Co., Ltd. announced the successful dosing of its first subject in its Phase 2 clinical trial for COVID-19 DNA vaccine candidate, INO-4800, in China. The dosing regimen involves two vaccinations at 0 and 28 days with either 1.0 mg or 2.0 mg dosing levels and is similar to the Phase 2 segment of Phase 2/3 clinical trial in the USA.
Dr. Bin Wang, Founder of Advaccine, said in a press statement: "After the completion of dosing for Phase 1 trial subjects at Huashan Hospital in Shanghai, China, with regulatory approval, Advaccine quickly launched the Phase 2 clinical trial with Jiangsu Provincial CDC team."
'Air travelers should not be systematically tested for SARS-CoV-2 or asked to quarantine on their return home from Europe because they are generally at low risk of having the virus,' says guidance from the European Centre for Disease Prevention and Control (ECDC), published on December 4, 2020. This advice means 'only people who have had known contact with someone with COVID-19 should be required to quarantine.'
The report published jointly with the European Union Aviation Safety Agency, and the ECDC, says that 'because SARS-CoV-2 is present in most European countries, imported cases are unlikely to significantly increase the rate of transmission.'
The UK government also announced on December 3, 2020, a limited number of exemptions for passengers arriving into England, including for business travelers who meet a set of required criteria.
The British Medical Journal reported on November 30,2 020, a study's findings suggest that ‘sore eye’ should be used to ascertain ocular symptoms linked to COVID-19. The most significant ocular symptom experienced by people suffering from COVID-19 was sore eyes.
Other symptoms associated with other types of conjunctivitis, such as mucous discharge and gritty eyes linked to bacterial infection, did not reach significance.
This study's data show that 81% of participants reported having experienced ocular symptoms within 2-weeks of other COVID-19 symptoms, and 80% reported that they lasted for less than 2-weeks.
A growing body of evidence suggests why children's immune systems appear better equipped to eliminate the SARS-CoV-2 coronavirus than are adults. A study published by the journal Nature on December 10, 2020, states: “Children are very much adapted to respond, and are very well equipped to respond to new viruses."
This study suggests that the reason children can neutralize the virus is that their T cells are relatively naive and are mostly untrained. They might have a greater capacity to respond to new viruses, a phenomenon the researchers are studying in more detail.
Their immune system sees the virus “and it just mounts this really quick and effective immune response that shuts it down, before it has a chance to replicate to the point that it comes up positive on the swab diagnostic test”, says Melanie Neeland, an immunologist who studied the family, at the Murdoch Children’s Research Institute in Melbourne, Australia.
The British Medical Journal (BMJ) reported the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is currently investigating (2) cases of anaphylactoid reactions in NHS staff who received the experimental vaccine BNT162b2 on December 8, 2020. Both people had a history of severe allergic reactions and carried adrenaline auto-injectors.
The MHRA has informed people running BNT162b2 vaccination sites in the UK to report any suspected adverse reactions and to ensure that they have appropriate resuscitation facilities available, stated the BMJ's Elisabeth Mahase, on December 10, 2020.
Reuters announced it has analyzed over 185,000 genome samples from the Global Initiative on Sharing All influenza Data (GISAID), the largest database of novel coronavirus genome sequences, to show how the global dominance of major SARS-CoV-2 strains has shifted over time.
The analysis was published on December 10, 2020, showing (7) main strains of the coronavirus.
The original strain, detected in the city of Wuhan, China, in December 2019, is the L strain. The virus then mutated into the S strain at the beginning of 2020. That was followed by V and G strains. Strain G mutated yet further into strains GR, GH, and GV. Several other infrequent mutations were collectively grouped together as strain O. The most recent mutation to emerge is the GV strain, which has so far been isolated to Europe where it has become increasingly common.
“If the virus changes substantially, particularly the spike proteins, then it might escape a vaccine,” commented Professor Catherine Bennett, Deakin’s Chair in Epidemiology.
The Government of Argentina and the Russian Direct Investment Fund announced an agreement on December 10, 2020, to supply the country with 10 million doses of Sputnik V vaccine, which is targeted against the SARS-CoV-2 coronavirus.
The U.S. CDC published a Research Letter on December 8, 2020, which stated 'we identified SARS-CoV-2 RNA in an oropharyngeal swab specimen collected from a child in Italy with suspected measles in early December 2019.'
This group of international researchers said: 'the amplicon was sequenced by using Sanger technology, resulting in a sequence of 409 bp. Sequence analysis performed by using BLAST showed 100% identity to the reference sequence Wuhan-HU-1 (GenBank accession no. NC_045512.2) as well as to sequences of other SARS-CoV-2 strains circulating worldwide at a later stage. Therefore, accurately determining the origin of the identified strain was not possible.'
Prof. Amendola and Dr. Bianchi at the Department of Biomedical Sciences for Health, University of Milan, Italy, led this study.
The Kingdom of Saudi Arabia’s Food and Drug Agency announced it has registered the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) for import and use in the country, reported SPA on December 10, 2020. The Authority said that based on the approval issued today, concerned health authorities will start the import procedures according to concerned standards and requirements.
The decision of the Authority’s approval of registering the experimental vaccine was based on the data provided by Pfizer on November 24, 2020.
Nepal Health Research Council has decided to test antiviral medicine favipiravir (Avigan) on COVID-19 patients admitted to hospitals in Kathmandu and Pokhara, reported Arjun Poudel, with local media. The influenza medicine, which is being administered under a phase-III trial, will be given to 600 patients with mild or moderate symptoms of the disease caused by SARS-CoV-2 virus infections.
Favipiravir is being manufactured by Deurali-Janta Pharmaceuticals Pvt. Ltd, located in Nepal.
