NEWS
Covovax is 9th COVID-19 vaccine OKd by WHO for emergency use
December 20, 2021 4:32 p.m.
THE World Health Organization issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus.
The vaccine, named CovovaxTM, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries.
WHO’s EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX vaccine supply. It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. ‘This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”
CovovaxTM was assessed under the WHO EUL procedure based on the review of data on quality, safety and efficacy, a risk management plan, programmatic suitability, and manufacturing site inspections carried out by the Drugs Controller General of India. The Technical Advisory Group for Emergency Use Listing (TAG-EUL), convened by WHO and made up of experts from around the world, has determined that the vaccine meets WHO standards for protection against COVID-19, that the benefit of the vaccine far outweighs any risks, and that the vaccine can be used globally.
CovovaxTM is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). It requires two doses and is stable at 2 to 8 °C refrigerated temperatures. The vaccine uses a novel platform and is produced by creating an engineered baculovirus containing a gene for a modified SARS-CoV-2 spike protein.
The originator product produced by Novavax, named NuvaxovidTM, is currently under assessment by the European Medicines Agency (EMA). WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation.
A meeting of WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) this week also reviewed the vaccine. SAGE formulates specific policies and recommendations for vaccines’ use in populations (i.e. recommended age groups, intervals between doses, specific groups such as pregnant and lactating women) and will issue recommendations for NuvaxovidTM/CovovaxTM in the coming days.
WHO emergency use listing
The emergency use listing (EUL) procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency while adhering to stringent criteria of safety, efficacy and quality. The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data, as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine. The WHO prequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability. (From World Health Organization)
NEWS
Atayde named Siklab’s Trailblazer of the Year awardee
3:49 p.m. December 4, 2024
FOR putting premium on grassroots sports development, Quezon City first district Rep. Juan Carlos “Arjo” Atayde will be honored with the Trailblazer of the Year award in the Nickel Asia Corporation Siklab Youth Sports Awards 2024 on Thursday at the Market! Market! Activity Center, Ayala Malls BGC in Taguig City.
Atayde’s efforts as a prime mover of the Youth Football League (YFL) will be recognized as well as for establishing the D1 basketball and volleyball leagues for the youth in Quezon City’s first district, where tournaments are shown live on Facebook everyday to inspire more kids to get into sports.
The QC District 1 Warriors, the team formed and supported by Atayde, crowned themselves champions of the 2024 CLS Cup in Indonesia last June after beating ACBA Tigers Sydney in the final.
The actor-lawmaker is also a staunch supporter of the QCSEP fencing team of City Councilor Joseph Juico that produced the likes of Paris Olympian Samantha Catantan, while giving life-changing opportunities through the YFL with his uncle YFL president Mike Atayde in discovering and developing 18-and-under talents through the years.
Organized by the Philippine Sports Commission-Philippine Paralympic Committee-Philippine Olympic Committee Media Group, the Siklab Youth Sports Awards’ Trailblazer of the year plum is awarded to outstanding individuals who promote quality grassroots sports development that created massive impact to the sporting community.
Three more special awards will be presented to Olympic boxing medalist Nesthy Petecio as this year’s Sports Idol, longtime sports manager Agapito “Terry” Capistrano as Godfather of the Year and noted youth sports supporter Senator Christopher Lawrence “Bong’’ Go as the recipient of the Lifetime Achievement Award.
A total of 80 youth and junior athletes from 37 sports will be recognized in the fourth edition of the awards night supported by Nickel Asia Corporation, Philippine Sports Commission, Philippine Olympic Committee, MVP Sports Foundation, CEL Logistics, Go For Gold, Barley + WHEATGRASS Entrepro, Pacquiao Coffee, Milo, San Miguel Corporation, PLDT and powered by Smart.
World junior champions Tachiana Mangin of taekwondo, weightlifters Angeline Colonia and Lovely Inan headline the Young Heroes Awards together with 2024 US Junior Girls champion Rianne Mikhaela Malixi of golf and wushu’s Alexander Gabriel Delos Reyes.
Joining them are Asian junior gymnastics gold medalist Karl Eldrew Yulo, world youth champion Isabella Butler of ju-jitsu, Asian age-group swimming gold medalist Jamesray Mishael Ajido and table tennis youth champion Kheith Rhynne Cruz.
Muay thai world champions Janbrix Ramiscal and Lyre Anie Ngina, chess Olympiad gold medalist Ruelle Canino will likewise be honored in the Super Kids Award category.
Three-time jiu-jitsu world champion Aleia Aielle Aguilar, Palarong Pambansa multiple gold medalists Albert Jose Amaro II (seven golds) of swimming, Mitchloni Dinauanao and Francis Dave Sombal (five golds each) of dancesports will banner the Rising Stars Award category.
Also leading the list are world youth muay champion Royeth Rosa, fencers Yuna Canlas, Willa Galvez, Hagia Del Castillo and Nicol Amethyst Canlas along with golfers Francesca Nicole Gaisano Gan, Geoffrey Drew Ong Tan, swimmer Behrouz Mohammad Mojdeh and figure skater Dawn Jasmine Gothong.
Thirty awardees have been lined up in the Youth Heroes Award including Ana Bhianca Espenilla (athletics), John Andre Aguja (cycling), JR Pandi (badminton), Brandon Sanchez (baseball), Kieffer Alas (basketball), Marc Dylan Custodio (bowling), Nick Anjelo Payla (boxing) and Naina Dominique Tagle (archery), Gavin Moses Bangayan Ti (obstacle course racing), Micaela Jasmine Mojdeh (swimming), Jonathan Reyes (squash), Jeniva Consigna (sambo) and Joseph Godbout (modern pentathlon).
Meanwhile, Ella Olaso (wrestling), Danielle Escolano (bowling), Xian Baguhin (boxing) Elaiza Yulo (gymnastics), Sebastien Mañalac (karate), Julia Claret Bintulan (karate), Zyche Mae Cruz Jizmundo (pencak silat), Shai Nitura (volleyball), Mariam Grace Balisme (wrestling), Paul Sondrei Capinig (wrestling), Andreas Lucho Aguilar (wrestling), Johanna Jeiel Barbero (wushu), Mark John Lazo (wushu), Carlstein Jade Dulay (sailing), Josa Gonzales (sailing), Marvin Mandac (cycling) and Thirdy Mana-ay (cycling) complete the roster for the Super Kids accolade.
NEWS
Shop local at DTI’s Christmas Village Fair in SM Megamall’s Megatrade Hall
3:36 p.m. December 4, 2024
Celebrate the holidays at the Department of Trade and Industry (DTI)-Bagong Pilipinas Christmas Village Fair at SM Megamall’s Megatrade Halls 2 and 3, happening from November 30 to December 4.
Discover unique gifts, festive treats, and handcrafted treasures created by talented local entrepreneurs. Shop local and make this Christmas truly special!
NEWS
9 Dynasty Cares helps typhoon victims in Kawit, Cavite
3:15 p.m. December 4, 2024
A GROUP of businessmen from Asia that provides entertainment across the continent including the Philippines donated a total of P3 million worth of relief goods last week to the recent typhoon victims in the province of Kawit, Cavite.
The 9 Dynasty Group, headed by its representative Derris Wong, together with his crew, met at least 1,000 affected families at the Barangay Santa Isabel in Kawit and provided them each with canned goods, bed sheets, noodles, rice, and other relief goods.
“At 9 Dynasty, we believe that in times like these, being there for one another is what matters most,” Derris said.
“Typhoons are merciless. So, we, here at the 9 Dynasty Group through our 9 Dynasty Cares program has spearheaded the donation drive for the typhoon victims.”
The residents of Cavite recently experienced the devastating impact of Typhoon Carina, and Tropical Storm Kristine last October, affecting their livelihood, while many people especially in Kawit were displaced due to heavy flooding in most areas.
Derris said in his speech during the donation activity at the barangay complex that they want the people to realize that there is still hope after every storm.
“We are here together to rebuild lives and transform this adversity into a story of hope,” he said.
“To help, we are providing ₱3 million in aid to support families with essential supplies and to rebuild homes, ensuring everyone has a safe place to stay before the holidays. We are here to let you know that you are not alone,” Derris added.
Aside from the 9 Dynasty Group, the donation drive was attended and coordinated by Santa Isabel Barangay Captain Avelino “Tamby” Fallago, his secretary Josephine Memije and VAWC personnel Remie Santonil.
“We are incredibly grateful and happy to 9 Dynasty Group’s generous act,” Fallago said on behalf of his constituents.
Atayde named Siklab’s Trailblazer of the Year awardee
Shop local at DTI’s Christmas Village Fair in SM Megamall’s Megatrade Hall
9 Dynasty Cares helps typhoon victims in Kawit, Cavite
