COVID-19 vaccination in the Philippines

The COVID-19 vaccination program in the Philippines will be an immunization campaign against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes coronavirus disease 2019 (COVID-19), in response to the ongoing pandemic in the country.

The Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer–BioNTech COVID-19 vaccine on January 14, 2021, prompting that a mass vaccination is underway in the following months. There are nine other COVID-19 vaccines on order for the program, at varying stages of development.

The vaccination program will start in February 2021.[1] The mass vaccination will begin in the 3rd quarter of 2021.[2]

Background

Vaccines on order

The Philippine government has been negotiating with various foreign vaccine manufacturers to secure the country's COVID-19 vaccine supply. These manufacturers include Sinovac Biotech (China), Gamaleya Research Institute (Russia), Moderna (United States), and Pfizer (United States).[3][4] The private sector, with government sanction, has secured at least 2.6 million vaccine doses from British-Swedish manufacturer AstraZeneca[5] The government also has secured 30 million doses from American firm Novavax which would be supplied from the Serum Institute of India.[6][7]

The government plans to secure 148 million doses from at least seven firms by the end of 2021.[8]

The procurement efforts of the national government have been a subject of various controversies. Health Secretary Francisco Duque has been alleged to have "dropped the ball" on a Pfizer vaccine deal which could have secured 10 million doses by as early as January 2021.[3] Plans to secure 25 million doses from China's Sinovac have also been subjected to scrutiny in Congress due to its reported efficacy rate. The efficacy rate of the Sinovac vaccine has varied by country; Turkey has reported an efficacy rate of 91%[9] while Brazil has reported an efficacy rate of 78%.[10] The Department of Health said that Siovac's vaccine satisfy the World Health Organization standards of at least 50 percent efficacy rate while the FDA pointed out that Sinovac is yet to publish an official and published scientific report on their vaccines efficacy rate and that the clinical trial for the vaccine is conducted in different countries and the efficacy rate per country will vary.[5][11][12]

By local governments

Local government units in the Philippines, from individual municipalities and cities and provinces has allocated part of their budgets to procure their own supply of COVID-19 vaccines.[13]

Along with private companies, local governments had to procure vaccines through cooperation with the national government which led to some members of the Congress questioning urging the national government to allow local governments to procure vaccines unilaterally. However, the government pointed out that only national governments could directly procure vaccines through the World Health Organization's COVAX facility and that third-party private firms and local governments had to sign a tripartite deal with the national government and member vaccine manufacturer.[14]

Approval

The FDA announced that three vaccine manufactures namely Pfizer–BioNTech, AstraZeneca, and Sinovac have inquired on the process of obtaining an EUA in the Philippines.[15] Pfizer applied for an EUA for the Pfizer–BioNTech COVID-19 vaccine on December 23, 2020[16] while Oxford–AstraZeneca did the same for AZD1222 on January 6, 2021.[17] On January 6, Gamaleya applied for an EUA for its Sputnik V vaccine.[18] On January 13, Sinovac applied for an EUA for its CoronaVac vaccine. On January 21, Bharat Biotech applied for an EUA for its Covaxin vaccine.

The FDA approved Pfizer–BioNTech's EUA application on January 14, 2021.[19][20] On January 28, the FDA approved Oxford–AstraZeneca's EUA application.[21]

Summary
Summary of vaccine procurement and approval (by the national government)
Vaccine Progress Doses ordered Approval Deployment
Pfizer–BioNTech COVID-19 vaccine phase III clinical trials 25 million January 14, 2021[20] Pending (Expected February 2021)[22]
Oxford–AstraZeneca phase III clinical trials 17 million January 28, 2021[21] Pending (Expected May or June 2021)[23]
Gamaleya phase III clinical trials – Under review Pending
Sinovac phase III clinical trials 25 million Under review Pending (Expected February 20, 2021)[24]
Bharat Biotech phase III clinical trials – Under review Pending
Moderna phase III clinical trials 20 million Pending Pending
Novavax phase III clinical trials 30 million Pending Pending
Arcturus phase II clinical trials – Pending Pending
Janssen phase III clinical trials 6 million Pending Pending
Clover phase II/III clinical trials – Pending Pending

History

Regulatory approval

Under normal circumstances, drugs and vaccines are reviewed for approval by the Food and Drug Administration (FDA) under a period of six months. President Rodrigo Duterte to fast-track the government's medical response to the pandemic signed an executive order on December 2, 2020 which allowed the FDA to grant emergency-use authorization (EUA) to COVID-19 vaccines and treatments.[25] An EUA for a particular vaccine would authorize the government to buy said vaccine and allow to use the same for the vaccination program. An EUA would not authorize the commercial use of such vaccines or consent the use of the vaccine for personal use.[17]

The EUA approval process by the FDA is covered under FDA Circular No. 2020-036.[26][27]

A EUA granted for COVID-19 vaccine or drug remains valid if it fulfills three conditions:[27]

  • Based on the totality of evidence including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19.
  • The known and potential benefits of the drug or vaccine...outweigh the known and potential risks, if any.
  • There is no adequate, approved, and available alternative to the drug or vaccine.

The EUAs validity ends one year from the lifting of the public health emergency status declared in response to the pandemic or one year from the date it was registered if a COVID-19 drug or vaccine gets fully registered with the FDA.[27]

Among the conditions is for a vaccine manufacturer to secure a EUA in the Philippines is to obtain prior EUA in its country of origin or other countries with a "mature" regulator.[15] No manufacturer would be allowed to obtain a EUA in the Philippines first. For the purpose of the FDA's EUA approval process, the following foreign regulators are considered as "mature":[27]

Vaccination program

The COVID-19 Immunization Program Management Organizational Structure was formed on October 26, 2020 to facilitate the distribution of COVID-19 vaccines in the Philippines, however this was replaced by a vaccine cluster within the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) by November 6, 2020. Carlito Galvez was appointed to lead the cluster[28] under the title of vaccine czar.[29] The Philippine National Vaccination Program and Implementation Plan was also approved by November 6, 2020.[28]

Vaccination of the Presidential Security Group

Duterte also said in December 2020 that some members of the military already received COVID-19 vaccine from Chinese manufacturer, Sinopharm despite the vaccine not yet officially approved by the country's health authorities.[30] Few days later, it was reported that some members of the Presidential Security Group had also received vaccine from an unknown manufacturer.[31][32]

Organizations involved

The COVID-19 Immunization Program Management Organizational Structure was formed on October 26 with the intention of it overseeing the distribution of COVID-19 vaccines once these became available. However, by November 6, the vaccine body was abolished and replaced with a vaccine cluster within the National Task Force Against COVID-19 of the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID). The vaccine cluster is distinct from the national task force's COVID-19 response cluster.[33]

The Food and Drug Administration (FDA) on their part is the agency tasked to review and approve the use and commercial distribution of COVID-19 vaccines in the Philippines[34] as well as the issuance of an emergency use authorization for the same.

Rollout schedule

Delivery plan

The national government plans to rollout its vaccination program in February 2021. Within the month the deployment of Pfizer's vaccines will start through the COVAX facility and the first batch of Sinovac's vaccines, consisting of 50,000 doses, will be delivered.[35]

References
  1. Gutierrez, Pia (February 2, 2021). "PH to finalize details of vaccine supply deals by month-end: Galvez". ABS-CBN News.
  2. "Mass vaccination to begin in Q3 — Galvez". CNN Philippines. February 2, 2021.
  3. Ramos, Christia Marie (December 27, 2020). "Moderna 'accelerating huge shipment' of COVID-19 vaccines to PH – Locsin". Philippine Daily Inquirer. Retrieved December 27, 2020.
  4. "Galvez: Bulk of COVID-19 vaccines for PH will come from US drug maker Novavax". Manila Bulletin. January 11, 2021. Retrieved January 11, 2021.
  5. Aurelio, Julie; Salaverria, Leila (December 27, 2020). "DOH: 50% vaccine efficacy is OK". Philippine Daily Inquirer. Retrieved December 27, 2020.
  6. "PH secures deal for 30M doses of Covovax COVID-19 vaccine". Philippine Daily Inquirer. January 10, 2021.
  7. Ranada, Pia (December 22, 2020). "Philippines eyes 30 million doses of Novavax vaccine". Rappler. Retrieved December 27, 2020.
  8. "PH to procure 148 million doses of COVID-19 vaccines this year". CNN Philippines. January 6, 2021. Retrieved January 6, 2021.
  9. "Sinovac's COVID-19 vaccine has 91% efficacy, Turkey says". Nikkei Asia. Retrieved January 11, 2021.
  10. "Sinovac Shot Shown 78% Effective in Brazil After Data Confusion". Bloomberg.com. January 7, 2021. Retrieved January 11, 2021.
  11. "Lacson: Philippines might have to settle for Sinovac after Duterte's threat vs. US on terminating VFA". GMA News. Retrieved January 1, 2021.
  12. "FDA chief: Scientific publication on Sinovac's efficacy yet to be released". GMA News. Retrieved January 1, 2021.
  13. "LIST: Local governments rolling out plans for free COVID-19 vaccines". Rappler. January 4, 2021. Retrieved January 6, 2021.
  14. Salaverria, Leila (January 13, 2021). "No national government 'monopoly' in COVID-19 vaccine procurement – Palace". Philippine Daily Inquirer. Retrieved January 12, 2021.
  15. "Three drugmakers eye vaccine emergency use in PH". CNN Philippines. December 15, 2020. Retrieved December 15, 2020.
  16. Esguerra, Darryl John (December 26, 2020). "Pfizer applies for authorization of its COVID vaccine in Philippines". Philippine Daily Inquirer. Retrieved December 27, 2020.
  17. Ferreras, Vince (January 6, 2021). "AstraZeneca applies for COVID-19 vaccine emergency use in PH – FDA". CNN Philippines. Retrieved January 6, 2021.
  18. "Russia's Gamaleya bids for emergency vaccine use instead of clinical trials". CNN Philippines. January 8, 2021. Retrieved January 9, 2021.
  19. Sabillo, Kristine (January 6, 2021). "FDA aims to decide on Pfizer vaccine emergency use by Jan. 14, AstraZeneca to apply soon". ABS-CBN News. Retrieved January 6, 2021.
  20. "PH authorizes Pfizer's COVID-19 vaccine for emergency use". CNN Philippines. January 14, 2021. Retrieved January 14, 2021.
  21. Tomacruz, Sofia (January 28, 2021). "Philippines approves AstraZeneca vaccine for emergency use". Rappler.
  22. "Philippines will get 50,000 Pfizer doses next month for free". News5. January 15, 2021. Retrieved January 15, 2021.
  23. "First batch of AstraZeneca COVID jabs to arrive May or June: presidential adviser". ABS-CBN News. January 20, 2021.
  24. Esguerra, Darryl John (January 13, 2021). "Sinovac to get EUA in PH before Feb 20 — Galvez". Inquirer.
  25. "Duterte allows FDA to issue emergency use authorization for COVID-19 vaccines, drugs". CNN Philippines. December 2, 2020. Retrieved December 14, 2020.
  26. "FDA Circular No. 2020-036: Guidelines on the Issuance of Emergency Use Authorization for Drugs and Vaccines for COVID-19". Food and Drug Administration of the Philippines. December 14, 2020. Retrieved January 6, 2021.
  27. Tomacruz, Sofia (January 6, 2021). "How FDA grants emergency approval for COVID-19 vaccines, meds". Rappler. Retrieved January 6, 2021.
  28. "IATF approves the Philippine National Vaccination Program and Implementation Plan". ptvnews.ph. November 6, 2020. Retrieved January 6, 2021.
  29. "VERA FILES FACT SHEET: The vaccine czar, explained". Vera Files. November 10, 2020. Retrieved January 6, 2021.
  30. "Duterte claims many in PH have received Sinopharm COVID-19 vaccine". Manila Bulletin. December 27, 2020. Retrieved December 27, 2020.
  31. "Vaccination probe: NBI counting on PSG chief's cooperation". Philippine Daily Inquirer. Retrieved January 3, 2021.
  32. "PSG chief: 'I take full responsibility' for unregistered vaccine use". Rappler. Retrieved January 3, 2021.
  33. "IATF replaces DOH-led task force with COVID-19 vaccine cluster headed by Galvez". CNN Philippines. November 6, 2020. Retrieved January 6, 2021.
  34. "Philippines warns of unapproved Covid-19 shots as soldiers get jabs". The Strait Times.
  35. Aguilar, Krissy (January 12, 2021). "PH eyes rollout of Pfizer's COVID-19 vaccine via COVAX facility in Feb". Philippine Daily Inquirer. Retrieved January 12, 2021.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.