AstraZeneca vaccine gets emergency use approval from WHO

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    THE World Health Organization (WHO) on Monday listed AstraZeneca and Oxford University’s COVID-19 vaccine for emergency use, widening access to the relatively inexpensive shot in the developing world.

    “We now have all the pieces in place for the rapid distribution of vaccines. But we still need to scale up production,” Tedros Adhanom Ghebreyesus, WHO Director General, told a news briefing.

    The AstraZeneca/Oxford shot has been hailed because it is cheaper and easier to distribute than some rivals, including Pfizer/BioNTech’s, which was listed for emergency use by the WHO late in December.

    The Philippines is expecting to receive vaccines from AstraZeneca and Pfizer this month and next month under the COVAX Facility.

    AstraZeneca’s vaccine makes up the lion’s share of doses in the COVAX vaccine-sharing initiative, with more than 330 million doses of the shot due to begin being rolled out to poorer countries from the end of February.

    The WHO established its emergency use listing (EUL) process to help poorer countries without their own regulatory resources quickly approve medicines for new diseases like COVID-19, which otherwise could lead to delays.

    The COVAX Facility, which is co-led by GAVI, the World Health Organization, the Coalition for Epidemic Preparedness Innovations and the UN Children’s Fund, has said doses would cover an average of 3.3% of total populations of 145 participating countries.

    COVAX is set to provide the Philippines with 117,000 doses of Pfizer/BioNTech vaccines and 9.2 million doses of AstraZeneca’s.

    The Philippine Food and Drug Administration said the WHO decision will pave the way for the immediate entry of the AstraZeneca vaccines in the country.

    FDA Director General Eric Domingo said the AstraZeneca vaccine can be used in the country because the FDA has issued an EUA last month.

    A WHO statement said it has approved the vaccine as produced by AstraZeneca-SKBio (Republic of Korea) and the Serum Institute of India.

    The British drugmaker, in a statement announcing the approval, said, “In the first half of 2021, it is hoped that more than 300 million doses of the vaccine will be made available to 145 countries through COVAX, pending supply and operational challenges.”

    The listing by the UN health agency comes days after a WHO panel provided interim recommendations on the vaccine, saying two doses with an interval of around 8 to 12 weeks should be given to all adults, and can be used in countries with the South African variant of the coronavirus as well.

    The WHO’s review found that the AstraZeneca vaccine met the “must-have” criteria for safety, and its efficacy benefits outweighed its risks.

    Vaccine czar Carlito Galvez Jr. and Joey Concepcion, presidential adviser for entrepreneurship, said he private sector, would have to turn to other drugmakers such as Novavax and its partner company, Serum Institute of India, for vaccine supplies as AstraZeneca and US firm Moderna are no longer accepting new orders because of limited supply.

    Concepcion and his “Go Negosyo” led at least 300 private companies in signing two tripartite agreements with AstraZeneca and the national government in November last year and in January this year for about eight million doses of vaccines.

    The first agreement involves some 30 multinational companies and was for more than two million doses that are expected to arrive in the third quarter of the year. The second agreement, which also involves local government units (LGUs), is for 17 million doses due in the third to fourth quarter of the year.

    Galvez said about 11 million of the 17 million doses had been allocated for 39 LGUs and the rest was for the more than 300 private firms.

    This is separate from the vaccines being purchased by the government from AstraZeneca and the 5.2 million to 9 million doses that will be sent to the country through COVAX.

    Concepcion urged interested private firms to place their orders as soon as possible as he noted more than 800 companies have expressed interest in securing vaccines from Novavax.

    Galvez said at least 10 million doses are available from Novavax. The government has signed a term sheet agreement with SII for 30 million doses of Novavax.

    The government targets to purchase 148 million doses of vaccine from multiple companies to inoculate 50 million to 70 million Filipinos this the year.

    Aside from AstraZeneca, the country is expected to receive an initial 117,000 doses from Pfizer under COVAX and 600,000 doses of vaccines donated by from Sinovac, a private Chinese firm, this February.

    The government is buying 25 million doses from China’s Sinovac Biotech, 10 to 15 million doses from Russia’s Gamaleya Institute, 20 million doses from Moderna, 15 million doses from Pfizer, and five million from Johnson and Johnson to inoculate the majority of Filipinos for free.

    Meanwhile, President Duterte on Monday night committed to certify as urgent the bills creating an indemnification agreement and amending the Procurement Act to hasten the COVID-19 vaccine negotiations, procurement and deliveries.

    Galvez said the government wants a P500-million indemnity fund indemnity fund set aside in the event that there are adverse effects to beneficiaries of the vaccines while the other measure would allow local government units to use their emergency funds to purchase vaccines under a tripartite agreement. – Gerard Naval, Jocelyn Montemayor and Reuters