Friday, October 30, 2020

3 Covid-19 vaccines under pre-screening for clinical trials: FDA

 By Raymond Carl Dela Cruz


At least three potential vaccines for the coronavirus disease 2019 (Covid-19) are under pre-screening but none authorized yet to administer clinical trials in the country, an official of the Food and Drug Administration (FDA) said on Friday.


In a virtual presser, FDA Director General, Undersecretary Eric Domingo said these vaccines are sponsored by Netherlands-based Janssen Vaccines & Prevention (Janssen), China’s Sinovac Biotech (Sinovac), and most recently, Clover Biopharmaceuticals (Clover) from Australia.


Both Janssen and Clover’s vaccines, Domingo said, are currently being evaluated by the Vaccine Expert Panel (VEP) while Sinovac’s is currently undergoing an ethics review and evaluation by the FDA.


“Yung most advanced [Sinovac] is still undergoing evaluation and we hope to have a decision on that within one to two weeks para malaman kung pasado siya o hindi (The most advanced, which is Sinovac’s, is still under evaluation and we hope to have a decision within one to two weeks to know whether it would be approved),” Domingo said.


He noted that Russia’s Gamaleya Institute and its Sputnik V vaccine would also soon be evaluated by the VEP.


“Yung Gamaleya yata meron pang mga tanong at hinihinging information yung VEP (For Gamaleya, I think there are still questions and some information that is being asked by the VEP) and when they submit that, then the formal evaluation of the vaccine expert panel will start,” Domingo said.


Once approved for clinical trial, he said these companies will be allowed to test their vaccines on thousands of human subjects in the Philippines, or up to 40,000 individuals from several different countries.


“We regulate this to protect human rights to make sure that the safety of human subjects is assured. And dapat syempre yung clinical data, yung integrity nun hindi make-question--sigurado tayo (And of course the clinical data, its integrity should not be questionable—we must be sure of it),” Domingo said.


No Covid-19 vaccines approved for sale


Following reports that some Chinese “clinical trial vaccines” for Covid-19 are being sold for up to PHP50,000 per dose, he said the FDA has conducted an investigation and found no vaccines in the reported facility.


“Kahit nagki-clinical trial ang mga produkto sa Pilipinas or sa ibang bansa (Even if these products are undergoing a clinical trial here in the Philippines or in other countries) and it's not a registered product, they cannot be promoted as safe and effective and definitely they cannot be sold,” Domingo said.


He noted that even medical products that have been donated to the country and approved for use by the FDA and the Department of Health (DOH) would need to undergo a separate evaluation and approval process before these can be sold in the country.


“We just want to remind everybody that there are still no registered Covid-19 vaccines in the Philippines. Kung meron po kayong nakikita na naga-advertise, nagbebenta, at sinasabi na meron na (If you find someone advertising, selling, or saying that it’s available), please report them directly to us,” Domingo said.


Earlier, Presidential Spokesperson Harry Roque warned the public of Covid-19 vaccines that are being sold but not approved by the FDA.


He noted that those found attempting to sell these vaccines through chain messages or other marketing methods will be punished under the law.


https://www.pna.gov.ph/articles/1120285

Proposed OFW dept to cover all needs of migrant workers: DOLE

An official of the Department of Labor and Employment (DOLE) on Friday said the creation of the proposed Department of Overseas Filipino Workers (OFWs) would be able to cover all the needs of Filipinos working abroad.


“But this time under one roof, you will see a Department that will protect not only the rights but especially, during pre-employment. We think this is the most important, the pre-employment situation, both in terms of regulation, in terms of welfare and in terms of really protecting them and giving all the benefits and the information they need for them to be successful Filipino citizens abroad,” Labor Undersecretary Joji Aragon said in a Laging Handa briefing.


Aragon, however, said this does not mean promoting overseas employment for Filipinos as a national policy.


"But can you imagine, bundling all of the services, programs, and policies of the government, which is kind of scattered, (is important),” she added.


She also reported that DOLE Secretary Silvestre Bello has informed the senators that he fully supports the creation of the new department.


“Secretary Bello last night sent another letter to the Senate, saying that he supports 100 percent the creation of Department of OFW, on whatever version they have. Let’s remember, the boxing is over, finally approved at the Lower House. In the Senate, it’s on the committee level and we can be sure, we were informed, it might be certified as urgent this 18th Congress,” Aragon said. “We believe that the creation of the Department of OFW, authored by Senator Bong Go and supported by practically all, will strengthen not only sea-based but also land-based.”


Aragon also reiterated the request of Bello for the Philippine Overseas Employment Administration (POEA) and Overseas Workers Welfare Administration (OWWA) to be part of the new Department.


“We hope that the POEA’s regulatory powers and quasi-judicial functions will be preserved and the OWWA who is in charge of the welfare side will likewise be preserved. We also have labor attachés, or POLOs (Philippine Overseas Labor Offices), in-charge on our half way homes, the so-called centers will be presented...” she added.


Aragon is hoping that the new Department will be formed this year or early next year.


In a public address on Tuesday, President Rodrigo Duterte renewed his call for the passage of a law creating a Department of Overseas Filipino Workers, saying the welfare of OFWs should be handled by a separate department other than DOLE.


He also promised the OFWs that there will be a more thorough review of policies for the protection of their rights.


https://www.pna.gov.ph/articles/1120271

Ipagdiwang ang Araw ng mga Santo - Kape't Pandasal kasama si Rissa Sings...

Here’s The Secret To Doing Everything Well

 Commit to the LORD whatever you do, and your plans will succeed.  Proverbs 16:3


Some have called it "the Protestant work ethic!"  But it isn't, really.  It is simply the application of several phrases found in Scripture which can be paraphrased, "If it's worth doing, it's worth doing right; so give it your best effort!"


Four times in the Bible you find a phrase that says, "whatever you do" and emphasizes a relationship between you and God.  The first is found in the Old Testament wisdom literature, specifically the book of Proverbs, mostly written by Solomon.  "Commit to the LORD whatever you do," says Proverbs 16:3, "and your plans will succeed.”  In this same context, the writer says that we as mortals make our plans, but the Almighty, not simply our scheming, determines their outcome.  That first "whatever you do" forges a link between your efforts, God, and success.  Application: When you really take Him as your partner in life--whether it is business or a marriage--what some think of as luck, the Bible says is really the blessing of God.


The second whatever you do is found in Paul's letter to the Corinthians where he wrote, "So whether you eat or drink or whatever you do, do it all for the glory of God" (1 Corinthians 10:31).  To understand the context of this advice, you need to know that the Corinthians were party animals, to use a contemporary expression.  They were debauched, immoral, and, depraved.  Successful merchants, yes, and proud of their accomplishments.  Personal pleasure was at the top of their leisure list.


Paul's advice to these new converts who had grown up in that culture was, whatever you do, whether it is what you say or what your actions are, strive to glorify God--not yourself.  Did his counsel run contrary to their habits and life-style?  Yes, 180 degrees.  Application: When you live a life of integrity and principle, your example is going to run counter to your culture.


When Paul wrote to the Colossians, whose city was an old but fading commercial center, he used that whatever you do expression twice. He first urged them to do whatever they did in the name of the Lord Jesus Christ and to give thanks to Him no matter what the result (Colossians 3:17).  Then Paul's second use of this same expression is this:  "Whatever you do, work at it with all your heart, as working for the Lord, not for men" (3:23).


The context of his remarks was labor relations, putting in a full day's worth of work for a full day's pay.  He reminded slaves that God expects more of his own children—that what counts is giving your best effort, realizing that ultimately God rewards your faithful service.


A closing thought.  Whatever you do includes everything you do--nothing excepted.  Sloppy work is no credit to those who claim to be followers of Jesus Christ.  The Bible makes it clear that whatever you do is a reflection on Him who called you to serve Him, and when you do less than your best, you dishonor your Father in Heaven.


Although the truth has been bent out of shape by some who link prosperity with how much you give, there is a definite link between success and the blessing of God in your life.  He's the unseen factor that can tilt the scales in your favor.  Take time to read Psalm 1, where as a preface to the entire book, the writer announces, "Blessed is the man [the person] who does not walk in the counsel of the wicked or stand in the way of sinners or sit in the seat of mockers.  But his delight is in the law of the LORD" (Psalm 1:1-2).


That phrase whatever you do is all-inclusive!  It's amazing how great is God's interest in--yes, whatever you do.


Resource reading: Psalm 1:1-6


https://www.guidelines.org/devotional/heres-the-secret-to-doing-everything-well/