J&J applies for emergency use

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    THE US drugmaker Johnson & Johnson (J&J) has filed for emergency use authorization (EUA) for its vaccine against the coronavirus disease (COVID-19), the Food and Drug Administration said yesterday.

    FDA Director General Eric Domingo said the EUA application was filed on Wednesday last week.

    Domingo said the FDA’s experts panel will evaluate J&J’s application.

    The single-dose vaccine, made by J&J’s vaccine arm Janssen Pharmaceuticals, has obtained an EUA from the US last month.

    J&J is is the seventh vaccine maker to apply for emergency use permit in the Philippines.

    According to the World Health Organization, the J&J vaccine was found to have an efficacy rate of 85.4 percent against severe COVID-19 cases, and 66.9 percent against moderate and severe infection.

    Aside from J&J, also awaiting decision from FDA is Bharat Biotech of India.

    Earlier approved EUA applications are those of American firm Pfizer-BioNTech, the British-Swedish firm AstraZeneca Plc, China’s Sinovac Biotech, and Russia’s Gamaleya.

    The Department of Health said the FDA is still waiting for Sinovac to submit additional evidence on whether its vaccine may be used for senior citizens.

    Health Undersecretary Maria Rosario Vergeire said the government asked Sinovac for additional studies to allow the FDA to amend provisions of its EUA.

    She said the DOH wants to explore the possibility of using Sinovac on senior citizens as AstraZeneca vaccines have run out.

    “We know that we need it because there are no more available AstraZeneca doses. We want to continue vaccinating our elderly citizens,” she said.

    In its EUA, the FDA the Sinovac vaccine CoronaVac may be used on clinically healthy persons aged 18 to 59 years.

    SHOW-CAUSE ORDERS

    Thirteen mayors, a governor, and a councilor have been issued show-cause orders by the Department of Interior and Local Government for allegedly jumping the line in the government’s COVID-19 vaccination program.

    The number includes the nine mayors named last month by the DILG and President Duterte, who had themselves inoculated ahead of healthcare workers who are at the top of the priority line.

    “As of today, 13 mayors, one governor and one councilor and I think we will be adding one more mayor today,” said Interior Undersecretary Epimaco Densing III.

    Densing did not identify the additional officials given the show-cause order.

    Five mayors who have been identified by the DILG were Alfred Romualdez of Tacloban City, Leyte; Dibu Tuan of T’boli, South Cotabato; Sulpicio Villalobos of Sto. Niño, South Cotabato; Noel Rosal of Legazpi City, Albay; and Abraham Iba of Bataraza, Palawan.

    The four mayors named by President Duterte were Mayor Peña of Minglanilla, Cebu; Victoriano Torres III of Alicia, Bohol; Virgilio Mendez of San Miguel, Bohol; and Arturo Piollo II of Lila, Bohol.

    Densing said the DILG is evaluating the explanation given by the 13 mayors, one governor and one councilor on why they got the jabs ahead of those in the priority list.

    Densing said the probe will continue even if the government recently elevated the local government officials, from B to A category, in the COVID-19 vaccination priority list, they being frontliners.

    “During the IATF (Inter-Agency Task Force for the Management of Emerging Infectious Diseases) meeting, I made a query whether the policy was prospective or retroactive and it was very clear that the decision on making our local chief executives as frontliners is prospective,” said Densing.

    “So all those those who jumped the line prior to this decision will continue to be evaluated on their responses to the show-cause orders. So the investigation will continue and if we find their reasons or justifications are not acceptable then we will still file the necessary complaints with the Office of the Ombudsman,” added Densing.

    Densing said the DILG is hoping to finish the probe in the next two weeks.

    Parañaque City Mayor Edwin Olivarez said ll mayors in Metro Manila have agreed to get inoculated to boost public confidence in vaccines.

    Mayors and governors are included in A4 group.

    “If they see the mayors, governors being vaccinated, there will be greater confidence among the public,” said Olivarez, concurrent chairman of Metro Manila Council. – With Victor Reyes and Noel Talacay