BRITISH drug manufacturer AstraZeneca has withdrawn its application to hold clinical trials for its vaccine in the Philippines, according to the Food and Drug Administration (FDA).
It comes after the drug maker accepted a proposal from Russia’s Gamaleya Research Institute to begin clinical trials of its AZD1222 vaccine alongside Sputnik V to study its efficacy since both use adenovirus vectors that contain the genetic material of the SARS-CoV2 virus spike protein.
The AZD1222 vaccine, which the British manufacturer developed jointly with the University of Oxford, will now be used alongside Sputnik V in clinical trials before the end of the year.
Gamaleya and Sputnik V vaccine financial backer, Russian Direct Investment Fund (RDIF), offered AstraZeneca to use one of the two components of the Sputnik Vaccine.
While both vaccines use adenovirus vectors that contain the genetic material of the SARS-CoV2 virus spike protein, they differ in the source of the vector, as AZD1222 used the adenovirus of the chimpanzee while Sputnik used human adenovirus vectors found in common cold.
According to the RDIF, the use of two different adenovirus vectors for a prime and boost immunization would be a “unique and ground-breaking discovery,” as this could raise efficacy and create long-term resistance to the virus.
“Scientific collaboration with Gamaleya Research Institute is important to explore the potential of vaccine combinations unlocking synergies in protection and accessibility through a portfolio approach.” the British drug maker said in a statement.
Sought for its reaction, FDA Director-General Rolando Enrique Domingo, in an email reply to The Manila Times, said AstraZeneca has “enough data” that convinced the developer to withdraw its application for clinical trials in the country.
He did not provide other details.
The drug manufacturer signed a deal with the Philippine government and the private sector for about 2.6 million doses of the vaccine, which will become available between May and June of 2021.
Presidential Adviser for Entrepreneurship and Go Negosyo founder Jose Maria “Joey” Concepcion 3rd, who rallied the private sector in securing the advanced commitment from AstraZeneca, declined to comment and would issue a statement next week.
Emergency use authorization
Despite withdrawing from the clinical trials, the vaccine developer can still apply for an emergency use authorization (EUA), which the FDA can grant by virtue of President Rodrigo Duterte’s Executive Order 121.
Before this, AZD1222 had been given approval by the country’s joint ethics review board and was awaiting approval from the Vaccine Experts’ Panel before being evaluated by the FDA.
AstraZeneca had separate clinical trials in the United Kingdom, Brazil, and South Africa, and had planned to do its trials in the country to see if the vaccine would encounter the same efficacy when injected on Asians, according to Jaime Montoya, executive director of the Department of Science and Technology-Philippine Council on Health Research and Development.
Aside from AstraZeneca and Gamaleya, other vaccines being considered for clinical trials are those by Sinovac Biotech Ltd., Janssen Pharmaceutica, and Clover Biopharmaceuticals.
The Vaccine Expert Panel and the Ethics Review Board has approved the vaccine by Clover Biopharmaceuticals.
‘No graft in vaccine purchase’
The Presidential Anti-Corruption Commission (PACC) will act to ensure the country’s deal for the purchase of vaccines against Covid-19 would be corruption-free, its head Dante Jimenez said on Saturday, following reports that Chinese firm and vaccine frontrunner Sinovac had bribed regulators to secure approvals.
Jimenez made the statement after the Washington Post reported that Sinovac has “acknowledged” a bribery case involving its chief executive officer (CEO).
In a statement, Jimemez promised that the PACC would make people in any department accountable if there would be any such allegations forthcoming and would bring the matter to “the attention of the President.”
Not another Dengvaxia scandal
“We don’t want a repeat of the Dengvaxia scandal, where irregularity in transactions was highly tolerated by the previous administration,” Jimenez said.
Jimenez was referring to the controversy that arose in November 2017 after French pharmaceutical company Sanofi Pasteur, Dengvaxia’s manufacturer, issued a belated advisory that the vaccine may lead to more severe symptoms of dengue for patients who have never been infected by the virus prior to vaccination.
This prompted the Department of Health (DoH) to stop the school-based dengue immunization program that was enforced under the previous administration. Several criminal complaints in connection with deaths supposedly linked to Dengvaxia have been filed by the Public Attorney’s Office.
Last week, Washington Post reported that Sinovac was about to run clinical trials of a SARS
vaccine and a swine flu vaccine in 2003 and 2009, respectively, when the bribery charges were made.
The company’s CEO admitted to giving more than $83,000 to a regulatory official from 2002 to 2011. In return, Sinovac’s vaccine certifications were reportedly expedited.
Sinovac is one of the dozen or so companies that have already reached Phase 3 clinical trials.
Palace spokesman Harry Roque Jr. had said Duterte was confident that the FDA would be able to perform its functions properly amid the allegations against Sinovac.
‘Too early to celebrate’
Sen. Christopher Lawrence “Bong” Go said it was “too early to celebrate” the holiday season without risking the spread of Covid-19 to oneself and one’s loved ones.
In a radio interview last Thursday, Go said the initial success in controlling the outbreak was made possible by people’s commitment to act responsibly by following the health and safety protocols issued by the government, which includes social distancing.
On Saturday, the DoH recorded 1,301 new Covid-19 infections, for a total of 448,331 cases, 30,168 of which are active.
There were 111 new recoveries recorded for a total of 409,433 survivors. The death toll increased to 8,730, including the 35 fatalities that were tallied on Saturday.
The Philippine government is eyeing to inoculate around 24.7 million Filipinos in the first part of the vaccination program.
Some 1.76 million health workers are first on the list of priority beneficiaries, followed by senior citizens, indigent Filipinos and uniformed personnel.
with CATHERINE VALENTE and JAVIER JOE ISMAEL