SINOVAC

CoronaVac ang aktwal na pangalan ng bakuna. Ito ay ginawa ng manufacturer, Sinovac Life Sciences Co., Ltd.

• Pananakit sa gugar na ininiksyunan

• Pananakit ng ulo

• Pagkaramdam ng pagod (fatigue)

• Hindi maayos ang pangkalahatang pakiramdam

• Lagnat o panginginig

• Sakit sa kasukasuan o kalamnan (joint pain o muscle ache)
  

Mababang tsansa na ang bakuna at maaring maging sanhi ng malubhang allergic reaction

Maaaring hindi lamang ito ang lahat ng mga posibleng epekto ng bakuna. Maaring may mga malubha at hindi inaasahang side-effects na mangyari. Ang COVID-19 Vaccine CoronaVac ay pinag-aaralan pa sa mga clinical trials.

Sanggunian: DOH Coronovac Flyer

Oo, Ligtas.

"Base sa ginawang pagsusuri ng Philippine Food and Drug Administration (FDA), na sinang-ayunan ng mga eksperto, maganda ang safety profile ni sa mga indibidwal na clinically health na nasa edad 18 hanggang 59 taong gulang.

Ang mga adverse event ay mild to moderate at mababa ang posibilidad ng allergy or anaphylaxis."

— DOH Infographic

Oo, Epektibo. Nakalap mula sa datos ng clinical trial na ito ay

• 50% epektibo para mapigilan ang banayad (mild) na sintomas

• 78% epektibo para mapigilan ang katamtaman (moderate), at

• 100% epektibo para mapigilan ang malubhang (severe) sintomas.

Source: DOH Infographic

Sinuri ng Food and Drug Administration ng Pilipinas ang Sinovac at binigyan ito ng Emergency Use Authorization noong 22 February 2021. Basahin ang buong EUA. Tingnan ang requirements upang mabigyan ng EUA ang isang bakuna laban sa COVID-19.

Sa kanilang five-page EUA na binigay noong 22 February 2021, sinabi ng FDA na:

"After careful consideration of the application, with all its supporting documents and a review of local experts, the FDA has been satisfied that all the conditions for the issuance of an EUA exist as provided under Executive Order (EO) No. 121, s. 2020 entitled “Granting Authority to the Director General of the Food and Drug Administration to Issue Emergency Use Authorization for COVID-19 Drugs and Vaccines, Prescribing Conditions Therefor, and for Other Purposes,” particularly:

1. Based on the totality of evidence available to date, including data from adequate and well- known controlled trials, it is reasonable to believe that the SARS-CoV2 Vaccine (Vero Cell), Inactivated [CoronaVac] may be effective to prevent, diagnose, or treat COVID-19;

2. The known and potential benefits of the SARS-CoV-2 Vaccine (Vero Cell), Inactivated [CoronaVac], when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of said Vaccine as of date; and

3. There is currently no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19.

In issuing this EUA, consideration has been given to the emergency use authorizations given by counterpart National Regulatory Authorities (NRAs) such as China, Brazil and Indonesia. This was followed by a rigorous and thorough review of all submitted published and unpublished clinical trial data and product information.

Basahin ang buong EUA.

Kasama sa EUA na ito ang mga detalye sa mga sumusunod, kasama ang:

• Profile ng bakuna

• Storage requirements

• Para kanino ang bakuna

• Tungkulin ng manufacturer, gobierno, at ng mga taga-administer ng bakuna

• At iba pa

Basahin ang buong EUA.

Pinayagan na ng Department of Health at Food and Drug Administration noong 7 Abril ang paggamit ng Sinovac para sa mga senior citizens, ngunit kailangang may kaakibat na mahigpit at mabusising pagsusuri ng kalusugan at "exposure risk" bago ito ibigay.

Sanggunian

Department of Health. 2021. "DOH, FDA Green-light Coronavac for Senior Citizens." Department of Health, 7 April. https://doh.gov.ph/doh-press-release/DOH-FDA-GREEN-LIGHT-CORONAVAC-FOR-SENIOR-CITIZENS

Kaunting Background

Dahil sa safety protocols, hindi sinama ang mga elderly sa mga unang trials para sa bakuna. Ngunit ngayon naibigay na ito sa marami, maari nang tumuloy nang may pag-iingat. Lahat po ng bakuna ay nasa ilalim ng EUA, kaya laging pong mamanmanan ang mga "special populations," kasama na rito ang elderly.

Heto ang mga payo't kaalaman mula sa World Health Organization

Ang efficacy ng isang bakuna at tumutukoy sa kakayahan nitong i-prevent ang isang karamdaman. Halimbawa, kung may 50 percent efficacy ang isang bakuna, ibig sabihin na kung 100 ang babakunahan laban sa isang sakit, 50 ang maaring magkaroon ng karamdamang iyon (Aubrey 2020).

Ayon sa Centers for Disease Control and Prevention, ang vaccine efficacy/effectiveness ay "interpreted as the proportionate reduction in disease among the vaccinated group. So a VE of 90% indicates a 90% reduction in disease occurrence among the vaccinated group, or a 90% reduction from the number of cases you would expect if they have not been vaccinated" (CDC 2012).

Sanggunian

Aubrey, Allison. 2021. "A COVID-19 Vaccine May Be Only 50% Effective. Is That Good Enough." NPR, 12 September 2020. https://www.npr.org/sections/health-shots/2020/09/12/911987987/a-covid-19-vaccine-may-be-only-50-effective-is-that-good-enough

CDC. 2012. "Lesson 3: Measures of Risk, Section 6: Measures Public Health." CDC, 12 May. https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section6.html

Nabalita na may 50.4 percent ang efficacy ng SInovac sa isang pag-aaral sa Brazil (BBC 2021). Ukol dito, ayon sa isang post (Lynas 2021) mula sa Cornell Alliance for Science noong 13 January 2021,

At face value this 50 percent efficacy figure looks disappointing — it’s not much better than your average flu vaccine. But what might be more important is that the trial shows a 100 percent effectiveness in preventing severe COVID-19, of the sort that kills people. So if you want to save lives and stop health services from being overwhelmed, this vaccine is fine. If you want to eradicate COVID-19, maybe it’s not quite good enough. (Emphasis/pagdiin sa amin)

Aniya ng isang doktor na kasapi ng UP Diliman COVID-19 Task Force, higit na makakatulong ito makaiwas sa pagkamatay dahil sa COVID-19, malubhang COVID-19, at pagkakaospital dahil sa malubhang COVID-19.

Dagdag rin ni Dr. Lulu Bravo, Executive Director ng Philippine Foundation for Vaccination, sa isang Senate Hearing noong Enero 2021,

“The 50 percent (efficacy rate) was actually set by WHO long before, in the beginning of the pandemic. They even said that an efficacy of 50 to 70 percent would be already acceptable. These efficacy rates are actually needed to be put in place when you have a severe pandemic, when the incidence are so high, the 50 percent efficacy would be good enough to have that kind of protection.........No protection is worse than a partial protection." (Mocon-Ciriaco 2021)

Sanggunian

BBC. 2021. "Sinovac: Brazil results show Chinese vaccine 50.4% effective." BBC, 13 January. https://www.bbc.com/news/world-latin-america-55642648
Lynas, Mark. 2021. "Does it matter that China's Sinovac COVID vaccine is only 50%." Cornell Alliance for Science, 13 January. https://allianceforscience.cornell.edu/blog/2021/01/does-it-matter-that-chinas-sinovac-covid-vaccine-is-only-50-effective/
Mocon-Ciriaco, Claudeth. "Vaccine expert tells Senate hearing Sinovac's 50-percent efficacy 'good enough.' Business Mirror, 15 January 2021. https://businessmirror.com.ph/2021/01/15/vaccine-expert-tells-senate-hearing-sinovacs-50-percent-efficacy-good-enough/

Ayon sa World Health Organization sa kanilang palinawag kung ano ang kahulugan ng efficacy,

"There is no single standard vaccine efficacy threshold that can be applied to all vaccines. Any decision to use a vaccine or drug always involves weighing the benefits against the risk. In some vaccines, like the malaria vaccine, we are willing to accept relatively low efficacy because the problem is so severe, and the need for some protection is so great.

The 50% efficacy threshold set for COVID-19 vaccines is because COVID-19 was deemed such a severe disease, that if a vaccine is only 50% effective, it’s still worth using. Fortunately, the emerging data on COVID-19 vaccines suggests that the vaccines are very safe with high efficacy, at least against some of the variants" (emphasis/pagdiin sa amin).

Para sa mas teknikal na paliwanag, tingnan ang batayan (WHO 2021) ng World Health Organization sa mga bakuna laban sa COVID-19.

Sanggunian

WHO 2020. "Considerations for the Assessment of COVID-19 Vaccines for Listing By WHO." WHO, 25 November. https://www.who.int/publications/m/item/considerations-for-the-assessment-of-covid-19-vaccines-for-listing-by-who

WHO. 2012. "What is COVID-19 Vaccine Efficacy." World Health Organization, Regional Office for Africa, 26 February. https://www.afro.who.int/news/what-covid-19-vaccine-efficacy

Sa isang pag-aaral sa Turkey, 83.5% naman ang naibalitang efficacy ng Sinovac (Tavsan 2021). Noong Enero 2021, apat ang nabalitang iba-ibang efficacy rates ng bakuna (Hong 2021).

Pati ang bakuna ng Oxford University at AstraZeneca ay magkaiba ang efficacy rate, 62 percent sa isang pag-aaral at 90 percent naman sa iba pa (Reuters 2021). Tingnan din ang vaccine profile ng Pfizer Biontech, Oxford AstraZeneca, at Gamaleya Sputnik V. Gawa ito ng Department of Health.

So bakit naiiba ang mga efficacy rates? Depende ito sa mga sumusunod:

"Trial size, patient criteria, duration of post-vaccination observation, target groups, prevalence of the virus in each site are among the factors that could impact efficacy, experts said" (Reuters 2021)

Halimbawa,

"ang bakuna ng AstraZeneca showed 62% efficacy when two full doses were administered to adult participants of all age groups, but it rose to 90% in a sub-group of smaller number of participants not older than 55 who were given a half-dose followed by a full dose booster" (Reuters 2021).

Sa kaso naman ng Sinovac,

"Brazil conducted trials with healthcare workers only, while Turkey and Chile recruited both medical workers and general public, and Indonesia general public only.

Medical workers could be more alert to mild symptoms and report those more proactively than general public, which Sinovac suspects may be among the reasons behind the less robust 50% reading, the person said" (Reuters 2021).

Ayon sa World Health Organization (WHO 2012) sa kanilang palinawag kung ano ang efficacy,

"There is no single standard vaccine efficacy threshold that can be applied to all vaccines. Any decision to use a vaccine or drug always involves weighing the benefits against the risk. In some vaccines, like the malaria vaccine, we are willing to accept relatively low efficacy because the problem is so severe, and the need for some protection is so great.

The 50% efficacy threshold set for COVID-19 vaccines is because COVID-19 was deemed such a severe disease, that if a vaccine is only 50% effective, it’s still worth using. Fortunately, the emerging data on COVID-19 vaccines suggests that the vaccines are very safe with high efficacy, at least against some of the variants" (emphasis/pagdiin sa amin).

***

Sanggunian

Hong, Jinshan. "China's Covid Shot Has Four Wildly Different Efficacy Rates." Bloomberg, 12 January. https://www.bloomberg.com/news/articles/2021-01-12/china-vaccine-going-global-with-four-different-efficacy-rates

Reuters. 2021. "Explainer: What's behind varying efficacy data for Sinovac's COVID-19 vaccine?" Reuters, 14 January. https://www.reuters.com/article/health-coronavirus-sinovac-explainer-int-idUSKBN29J0M1

Tavsan, Sinan. "Sinovac's COVID-19 shot is 83% effective, not 91%, Turkey says." Nikkei Asia, 4 March. https://asia.nikkei.com/Spotlight/Coronavirus/COVID-vaccines/Sinovac-s-COVID-19-shot-is-83-effective-not-91-Turkey-says

WHO. 2012. "What is COVID-19 Vaccine Efficacy." World Health Organization, Regional Office for Africa, 26 February. https://www.afro.who.int/news/what-covid-19-vaccine-efficacy

Boluntaryo po ang pagtanggap ng Sinovac. Kung nais maghintay ng iba pang brand ng bakuna, tandaan lang na habang wala tayong bakuna, nariyan pa rin ang panganib na magkaroon tayo ng COVID-19.

Hindi pa rin natin alam, sa ngayon (late April 2021), kung kailan magiging available ang iba pang bakuna, o kung maidi-distribute siya sa buong bansa.

Kaya nasa ating pakinabang makakuha ng proteksiyon mula sa COVID-19 sa lalong madaling panahon, lalo na't tayo'y nasa isang pandemya kung saan maaring pabugsu-bugso ang mga kaso ng COVID-19.

Sabi nga nila, "the best vaccine is the one that's available now."

Ayon sa World Health Organization (WHO 2012) sa kanilang palinawag kung ano ang efficacy,

There is no single standard vaccine efficacy threshold that can be applied to all vaccines. Any decision to use a vaccine or drug always involves weighing the benefits against the risk. In some vaccines, like the malaria vaccine, we are willing to accept relatively low efficacy because the problem is so severe, and the need for some protection is so great.

The 50% efficacy threshold set for COVID-19 vaccines is because COVID-19 was deemed such a severe disease, that if a vaccine is only 50% effective, it’s still worth using. Fortunately, the emerging data on COVID-19 vaccines suggests that the vaccines are very safe with high efficacy, at least against some of the variants" (emphasis/pagdiin sa amin).

***

Sanggunian

WHO. 2012. "What is COVID-19 Vaccine Efficacy." World Health Organization, Regional Office for Africa, 26 February. https://www.afro.who.int/news/what-covid-19-vaccine-efficacy

Kailangan nating makumpleto ang dose ng bakuna bago tayo makakuha ng pinakamataas na proteksiyon. Huwag pong kampante. Patuloy na mag-ingat.

Tingnan po ang mga puwede at hindi puwedeng gawin, at mga kaakibat na pag-iingat, ang "When You've Been Fully Vaccinated" na page ng Centers for Disease Control and Prevention sa Amerika.

Magtungo rin po sa "Pagkatapos Magpabakuna" page ng website na ito.