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)
Filipinas clobber Singaporeans to grab Group A lead in AFF tourney
July 7, 2022 9:37 p.m.
SKIPPER Tahnai Aniss scored a brace as the Philippine outplayed Singapore 7-0 yesterday to seize the Group A lead in the 15th Asean Football Federation Women’s Championship at the Rizal Memorial Stadium.
Doing a yeoman’s job for the Filipinas, Aniss scored in the 10th minute off an own-goal by Singapore goalie Beatrice Tan then had a long looping header in the 19th in anchoring the hosts to their second straight win following a 1-0 upset of Australia last Monday.
With her accurate cross passes, Aniss also set up Sarina Bolden, who scored the game-winner against Australia, with another header in the 38th minute and newcomer Kaya Hawkinson, who scored on a glancing header 11 minutes into the second half.
Slipping past two Singapore defenders, teener Isabella Flanigan opened the scoring floodgates in the 8th minute, Sara Eggsevik had one in the 56th and Anicka Castaneda , who came off the bench in the second half, added the seventh marker on a follow-up in the in the 69th.
With the victory virtually ensured, Aniss earned a well-deserved respite and was relieved by Kathleen Rodriguez in the 58th minute of the competition organized by the Philippine Football Federation.
With their second consecutive win, the charges of coach Alen Stajcic were proudly on top of Group A with six points while the Singaporeans absorbed their first loss in two matches after a scoreless draw with Malaysia last Monday.
Earlier, Thailand refused to be cowed by Australia yesterday, showing remarkable resiliency and rallied for a well-earned 2-all draw against their fancied rivals.
Down at 1-2 at the break, the never-say-die Thais levelled the count through Ploychomphoo Somnuek, who struck with a nifty 20-yard volley that hit the top right corner of the net beyond Aussie goalie Jada Mathyssen-Whyman’s reach in the 60th minute.
Kanyanat Chetthabutr had earlier kept the four-time AFF Women’s football champions in the thick of the fight by scoring their first goal from near the midcourt line in the 40th minute, hitting the ball just hard enough past Mathyssen-Wyman, who strayed too far out of the net.
Following their 4-0 rout of Indonesia last Monday, the charges of Japanese coach Miyo Okamoto had four points and were in second spot in the group.
The Matildas, who dropped a 0-1 decision to the Filipinas two days ago, had only one point to show in two matches.
Aiming to maximize his bench, Stajcic made some changes in his starting lineup, tapping Inna Palacios, making her 50th cap, as the goalie over Oliva McDaniel while giving midfielder Hawkinson and defender Maya Alcantara their national team debuts.
“0bviously this showed we have a deep bench and the great unity of the team,” noted Stajcic in utilizing most of his players.
The Filipinas try to enhance their semifinal prospects when they go for their third consecutive victory as they face Malaysia, which drew 1-1 with Indonesia at the Binan Stadium, tomorrow.
New COA chief Calida vows to protect people’s money
July 6, 2022 1:46 p.m.
AS LONG as he is in power, newly appointed Commission on Audit chairman Atty. Jose Callangan Calida recently assured Filipinos that public public funds will be safeguarded.
“We are not just acting to promote excellence, but also to make it a habit here in COA. We have to do our job properly, be the best in our field,” Calida of Davao City said, adding that the government’s auditing agency will be transparent and fair to the public.
Calida met the media during his first day in the office, saying that he would do whatever it takes to protect every single centavo of the people’s money.
The Commission on Audit is an independent constitutional commission with the primary function to examine, audit and settle all accounts and expenditures of the funds and properties of the Philippine government.
“COA auditors should correctly scrutinize and carefully inspect accounts. I believe they are the best in the field and we’re here to fight corruption in the government,” he added. “I am warning anybody in COA that if there are shenanigans and mischievous activities, I will remove them.”
The former Solicitor General under the term of former President Rodrigo Duterte met for the first time COA’s commissioners, lawyers and other officials on Monday morning at the COA main office in Quezon City.
Calida, who will be turning 72 on Thursday, also thanked employees of COA for the warm welcome. “Those who are earnest in their work, they will remain in this office and will be rewarded.”
Jayke Joson, a former actor producer, and Jay Ruiz, former news anchor and TV host, were seen accompanying Chairman Calida in his first day at COA.
“We are here to help the new COA chairman set up everything in his first day in office. We believe in him, that’s why we volunteered to give an extra hand to help our Good Chairman in his first day. Atty. Calida is our idol. We call him the Enforcer, because he always enforces the law,” Joson said.
“President Marcos appointed a very reliable person to COA. With his track record, he always get the job done. He will not let us down,” he added.
Newly proclaimed President Ferdinand “BongBong Marcos Jr. appointed Calida to lead the COA due to his superb expertise in law and achievements when he led the Office of the Solicitor General, among other government agencies.
Crossovers seek PVL redemption in Invitationals
July 5, 2022 7:01 p.m.
2:30 p.m. – Cignal HD vs Army
5:30 p.m. – Choco Mucho vs Chery Tiggo
From top to near-bottom, Chery Tiggo believes there’s no way to go but up as the Crossovers seek to get over the hump of their Premier Volleyball League Open Conference debacle with another top podium finish in the PVL Invitationals unfolding this weekend.
Sure, Jaja Santiago’s absence told heavily on their unsuccessful title-retention drive but limping to eighth place in a field of nine certainly didn’t speak well of the caliber of the players, who, under then-head coach Aaron Velez, bucked the odds and defanged the fancied Creamline Cool Smashers in a gripping Open finale in bubble setup in faraway Ilocos Norte last year.
But the Crossovers struggled without the 6-5 middle blocker in the recent Open that saw them grope for form at 1-3 in pool play, lose to the Cool Smashers in the quarterfinals and bow to the cellar-dweller BaliPure Water Defenders in the classification round.
The team management felt it was time to do a crossover, tapping coach Clarence Esteban to whip the team back into fighting form, fulfill the team’s goal to rebound and earn at least another crack at the championship.
That’s despite the pressure and challenge not just from the rest of the six other local squads but also from two top-notch foreign teams spicing up the title chase in the second round of the mid-season offering of the league organized by Sports Vision.
“Our lineup is intact since all players have existing contracts. So our focus is on improving their skills and abilities. We want them to play as a team and we will instill the importance of the role of each individual inside the court,” said Esteban, also the man at the helm of UST boys’ volley squad and current coach of Mapua’s women’s team.
“Expect us to give our very best to rebuild and organize the team for us to achieve our goal,” he added.
Chery Tiggo kept assistant coach Brian Esquivel while Yani Fernandez returns after helping steer Foton to the 2015 Superliga Grand Prix title romp. Joining them are trainer Robertly Boto and strength and conditioning coach Kevin Villegas.
Velez is now the team manager.
Meanwhile, the league will have a press conference with social media platform KUMU today (Wednesday) from 2 p.m. to 4 p.m. at the Infinity Ballroom of F1 Hotel Manila in Global City, Taguig.
“We knew what we went through the last conference, so we will work hard and will do it step-by-step to be able to perform well this conference,” said ace Dindin Santiago-Manabat.
The veteran power hitter, however, said Jaja Santiago still won’t be around due to her commitment in Japan but the team remains as talent-laden as ever with Mylene Paat, EJ Laure, Jasmine Nabor and Buding Duremdes raring to showcase their wares and the rest of the Crossovers eager to step up and put Chery Tiggo in the conversation again.
“While the team had a disappointing campaign the last time out, we will not disappoint the team management for the trust it has given us to lead and guide this team,” added Esteban, whose wards will be as much tested as the rest as it kicks off its campaign against Choco Mucho, one of the young but tall and talented squads in the league, on Saturday at the Filoil Flying V Centre.
They clash at 5:30 p.m. after the 2:30 p.m. tussle between Cignal HD and Army Black Mamba.
Petro Gazz and PLDT complete the seven local teams with the top four after the single round elims advancing to the next stage that will feature Japan’s Kobe Shinwa Women’s University and Chinese-Taipei’s Taipei King Whales.
Games will be aired live on One Sports (free to Air Ch 41 and Cignal CH 6) and One Sports+ (Cignal Ch 91 SD, Ch 261 HD) with both channels also available on Cignal’s OTT Platform, Cignal Play, with video on demand also available on the platform.
Matches can also be streamed on social media application KUMU and on the league’s official website pvl.ph.
All the games will be played at the San Juan venue except for the July 23 playdate that will feature Creamline against Choco Mucho, set at the SM Mall of Asia Arena in Pasay.