The World Health Organization chief hailed as “encouraging” Pfizer and BioNTech’s announcement Monday that their vaccine has in trials proved 90-percent effective in preventing Covid-19 infections.
The two pharmaceutical companies said the vaccine they have jointly developed had during Phase 3 trials provided protection to nearly all patients seven days after the second of two vaccine doses.
“We welcome the encouraging vaccine news from @pfizer &@BioNTech_Group & salute all scientists & partners around the who are developing new safe, efficacious tools to beat #COVID19,” WHO director Tedros Adhanom Ghebreyesus said in a tweet.
“The world is experiencing unprecedented scientific innovation & collaboration to end the pandemic,” he said.
Candidate vaccines
As of mid-October, the WHO has identified 42 “candidate vaccines” at the stage of clinical trials, up from 11 in mid-June.
Ten of them were at the most advanced phase 3 stage, in which a vaccine’s effectiveness is tested on a large scale, generally tens of thousands of people across several continents. WHO chief scientist Soumya Swaminathan said in a tweet Monday that the news from Pfizer and BioNTech should “encourage all developers of #COVID19 vaccines to continue with clinical trials.”
“The world needs several safe, effective & affordable vaccines to end this pandemic,” she said.
Record highs
Across much of the globe, COVID-19 infections rates are hitting record highs, with hospital intensive care units filling up and death tolls mounting.
Based on supply projections, the companies said they expect to supply up to 50 million vaccine doses globally in 2020, and up to 1.3 billion doses in 2021.
US biotech firm Moderna, several state-run Chinese labs, and a European project led by the University of Oxford and AstraZeneca are thought to be closing in on potentially viable vaccines.
Two Russian COVID-19 vaccines have been registered for us even before clinical trials were completed, but have not been widely accepted outside of Russia.
Clinical trial
The Phase 3 clinical trial—the final stage—of the new vaccine, BNT162b2, began in late July and has enrolled 43,538 participants to date, 90% of whom have received a second dose of the vaccine candidate as of November 8.
Pfizer said it is gathering two months of safety data following the final dose – a requirement of the US Food and Drug Administration – to qualify for Emergency Use Authorization, which it expects by the third week in November.
"We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks," Bourla said.
Dozens more candidates
The so-called messenger RNA, or mRNA, vaccine is a new approach to protecting against viral infection.
Unlike traditional vaccines, which work by training the body to recognize and kill proteins produced by pathogens, mRNA tricks the patient's immune system to produce viral proteins itself.
The proteins are harmless, but sufficient to provoke a robust immune response.
The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication. AFP with Willie Casas
Question of accuracy
Meanwhile, Department of Science and Technology Secretary Fortunato dela Pena said on Tuesday that the emergency use of Pfizer's vaccine candidate against coronavirus disease 2019 (Covid-19) is unlikely in the Philippines.
"We need to verify the accuracy of (Pfizer's) claim that the vaccine is 90 percent effective. If (Pfizer) will apply to conduct a clinical trial here, the Vaccine Expert Panel will check the data, and would verify the claim," he said during a Laging Handa public briefing.
On Monday, Pfizer announced that its candidate vaccine was found to be "more than 90 percent effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis".
The pharmaceutical firm plans to submit an Emergency Use Authorization to the US Food and Drug Administration around the third week of November.
Pfizer's announcement was based on a Phase 3 clinical study. De la Peña pointed out that the Philippines requires Phase 4 clinical trials for the vaccine candidates.
The DOST chief noted that Philippine authorities could not rely on Pfizer's announcement, since it was the firm's announcement. "We do not know the data that supports (the claim)," he said.
In case Pfizer would not conduct a clinical trial in the Philippines and would submit an application to the Philippine FDA for supply purposes, that would still be referred to the Vaccine Expert Panel for analysis, he added.
Solidarity Vaccine Trial
Meanwhile, de la Peña said there is no date yet as to when the WHO Solidarity Vaccine Trial for Covid-19 would commence.
"As of November 10, we have not received the list of vaccines and the protocols from the WHO," he said.
Most probably, the vaccines in the WHO's list would be those that have finished the Phase 3 clinical trials, according to de la Peña.
Protocols from the WHO would include the age group of clinical trial participants, the number of doses, the required temperature for storage, among others, de la Peña said.
Philippine Covid-19 cases
The Philippines logged on Tuesday 1,347 new coronavirus disease 2019 (COVID-19) cases bringing the total to 399,749, as eight laboratories failed to submit reports, the Department of Health said.
In a report, the DOH said a total of 8 labs were not able to submit their data to the COVID-19 Data Repository System on November 9, 2020.
Top cities and provinces with new daily cases are Cavite, 92; Manila, 77; Quezon City, 58; Baguio City, 55; and Laguna province, 52. There are 30,169 active cases, or 90.5 percent of the total number of cases.
Of the figure, 83 percent are mild; 9.4 percent are asymptomatic; 4.8 percent are critical; and 2.7 percent are severe.
The DOH also reported 187 new recoveries, bringing the total recoveries to 361,919 or 90.5 percent of the total cases.
The DOH likewise reported 14 new fatalities bringing the death toll to 7,661 or 1.92 of the total cases.
Bed capacity
Nationwide, of the approximately 1,900 total ICU bed capacity, 54 percent are available; of the approximately 13,500 total isolation bed capacity, 58 percent are available; of the 5,900 total ward bed capacity, 68 percent are available; and of the approximately 2,000 total units of ventilators, 78 percent are available.
A total of 47 duplicates were also removed from the total case count. Of these, 43 were recovered cases.
Moreover, nine cases previously tagged as recovered were reclassified as deaths.
Additionally, the lower number of new reported cases today may be attributed to the relatively lower reporting rate of laboratories for November 9, 2020.
Based on initial analysis, only 84% of laboratories reported for that day, which is lower compared to the previous days wherein there were laboratory reporting rates of 90% or more.
“We will continue working with our laboratories to ensure prompt and complete submission of data to the DOH Central office,” said the DOH.
Guidelines for Christmas
As the holiday season approaches, the DOH issued guidelines for Christmas celebrations amid the coronavirus pandemic.
Interior Secretary Eduardo Año also suggested a shift to online caroling after some local governments banned caroling in the streets over the holidays.
New Covid-19 czars
Meanwhil, Health Secretary Francisco Duque said he has no qualms about President Rodrigo Duterte appointing COVID-19 czars.
“It’s not about control, it is really about seamless coordination and integration of efforts,” said Duque, in his response on being asked if the appointment of different czars diminished his control over the country's response to the COVID-19 pandemic, during the DOH Beat COVID-19 Media Forum last November 9.
“This is everyone’s job, no one person can be able to lead the response in COVID-19 pandemic,” said Duque.
“Remember, this brought the whole world to its knees and we need all hands on deck,” Duque said.
In a bid to intensify COVID-19 response measures, the Philippine government designated anti-COVID czars to lead each of the components of the government’s COVID-19 strategy, which are testing, tracing, isolation, and treatment.
In his July 13 press briefing in Malacañang, Presidential Spokesperson Secretary Harry Roque, Jr. introduced the four anti-COVID czars, namely, Secretary Vivencio “Vince” Dizon as Chief Testing Czar, Baguio City Mayor Benjamin Magalong as Chief Tracing Czar, Public Works and Highways Secretary Mark Villar as Chief Isolation Czar, and Health Undersecretary Leopoldo “Bong” Vega as Chief Treatment Czar.
All four anti-COVID czars will be directly under the National Task Force Against COVID-19 led by Chief Implementer Secretary Carlito Galvez Jr.
The Palace official said that the government recognizes the recent spike in COVID-19 cases in the country and assured the public that the situation can be controlled.
Philhealth anomaly
Duque is facing several criticisms, especially regarding the anomalies in the Philippine Health Insurance Corp. (PhilHealth) and his performance in handling the COVID-19 pandemic.
Ombudsman Samuel Martires recently suspended for six months without pay eight senior officials of Philippine Health Insurance Corp. (PhilHealth) who are facing administrative and criminal complaints in connection with the alleged irregular release of P2.7 billion from the insurer’s interim reimbursement mechanism.
Duque serves as PhilHealth board chairman.