EUA on Pfizer vaccine won’t be revoked yet despite Norway deaths, DOH says

Robie de Guzman   •   January 18, 2021   •   482

MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.

Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.

Vergeire also said that studies need to be done on the matter.

“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.

“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.

The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.

FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.

Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.

“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.

“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)

Evaluation of EUA application for Sinopharm vax may be completed in less than 21 days – FDA

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The evaluation process for the Sinopharm COVID-19 vaccine will not take long before it can be granted an emergency use authorization (EUA) in the Philippines, the Food and Drug Administration (FDA) said Tuesday.

FDA director-general Eric Domingo said the Sinopharm vaccine has already been included in the emergency use listing (EUL) of the World Health Organization (WHO) and access to its documents, including inspection reports from the WHO will be faster.

“Useful yung kanyang Emergency Use Listing sa WHO kasi before this, wala pa siyang EUA from a stringent regulatory authority katulad ng mga USFDA ganyan or Europe, Japan… hindi pa siya listed sa mga iyon. Pero yung WHO na emergency use listing that’s equivalent to a stringent regulatory authority,” he said.

“Ang maganda sa WHO kasi very transparent ang documents nyan. Available din siya sa FDA. Lahat ng ni-review nila, maaari naming ma-access kaya hindi tayo masyado mahihirapan sa paghingi ng information,” he added.

The Department of Health (DOH) earlier said it has started the process of applying for EUA, pending documents about the vaccine product.

The FDA said the process may take less than 21 days once the DOH completes the application process.

“Kapag ganyan na merong WHO EUL, mas mapapabilis iyan. Nakakaya natin iyan usually less than 21 days,” Domingo said.

The FDA also echoed the DOH’s earlier statement that there are no irregularities with the government’s move to file an EUA for a Chinese-made vaccine since they also applied for the EUA of other COVID-19 vaccine brands, such as Sinovac, AstraZeneca, and Pfizer, in order for these vaccines to be delivered to the country.

“Talagang nasa batas and it’s a worldwide practice,” he said. “Based on WHO guidelines, posible naman na gobyerno gusto bumili ng bakuna na walang local manufacturer or representative dito. In those cases, the government itself can get EUA.”

“Hindi naman conflict yun dahil ang EUA ay hindi naman product registration o marketing authorization lang, talagang for emergency use lang ang mga bakuna,” he added. – RRD (with details from Correspondent Aiko Miguel)

Philippines posts 4,734 new COVID-19 cases

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The Philippines on Tuesday recorded 4,734 new cases of novel coronavirus disease (COVID-19), pushing the total tally to 1,113,547.

In the latest bulletin, the Department of Health (DOH) said the country’s total number of active cases is at 56,752.

Of this number, 93.4 percent are mild, 2.2 percent are asymptomatic, 1.8 percent are severe, and 1.4 percent are in critical condition.

The DOH said the lower case count is due to the low number of samples received by the laboratories. At least 12 laboratories also failed to submit their data last Sunday.

Ngayong 4 PM, Mayo 11, 2021, ang Department of Health ay nakapagtala ng 4,734 na karagdagang kaso ng COVID-19. Samantala…

Posted by Department of Health (Philippines) on Tuesday, May 11, 2021

The number of recoveries rose to 1,038,175 after 7,837 more patients recuperated from the viral respiratory disease.

The death toll climbed to 18,620 with 59 new fatalities.

The DOH also reported in its bulletin a positivity rate of 12.2 percent out of 32,205 tests.

The case count reflected in the latest bulletin was based on tests conducted on May 9, it added.

2 cases of B.1.617 COVID-19 variant have no travel history to India – DOH

Robie de Guzman   •   May 11, 2021

MANILA, Philippines – The B.1.617 coronavirus disease (COVID-19) variant first detected in India has been found in the Philippines, the Department of Health (DOH) confirmed Tuesday.

The DOH said the two cases found with the said variant are two male overseas Filipino workers. One patient is a 37-year old male who arrived from Oman on April 10, while the other is a 58-year old male who came from the United Arab Emirates (UAE) on April 19.

According to DOH Epidemiology Bureau Director Alethea de Guzman, the patients have already been tagged as recovered and released from quarantine after they tested negative for the virus.

 “Yung ating dalawang kaso po have already been tagged as recovered and as mentioned, they are currently asymptomatic,” De Guzman said during an online briefing.

“It’s been more than 2 weeks for one, and almost a month mula nang unang arrival ng isang kaso natin. Yung unang kasong nabanggit natin na nasa region 12 na po ay nag-test negative na po on their repeat PCR,” she added.

 There were no listed close contacts of the two cases, De Guzman said.

 “Dahil ang ating mga kaso naman pagdating ay nailagay na sa quarantine tapos nilipat sa isang isolation facility mula nang mag-test positive, wala po tayong na-detect na close contacts,” she said.

The two patients also had no travel history to India based on their information, De Guzman added.

The B.1.617 variant was first detected in India last October 2020 and is currently found in 46 countries, according to the global genome database (GISAID).

De Guzman said this variant has at least 15 different mutations, with two mutations of significance in the spike region – L452R and E484Q.

Health experts said that the mutation L452R has been associated with increased transmissibility and reduced antibody neutralization, which means that this may help the virus evade antibodies in recovered or vaccinated individuals.

The mutation E484Q, meanwhile, can increase the virus’ binding capacity to the ACE2 receptor and may help the virus escape immune response.

“Further studies are necessary to understand the transmissibility, infectivity, and effect on vaccine efficacy of the B.1.617 variant,” experts said.

The World Health Organization (WHO) on Monday classified the B.1.617 variant as a “variant of concern at the global level.” This is the fourth coronavirus variant to be classified as such, joining the B.1.1.7 (United Kingdom), B.1.351 (South Africa), and P.1 (Brazil) variants.

The WHO defines a variant of concern as more contagious than the original form, hard to control or they lead to more severe illness.

The B.1.617 variant contains mutations linked to increase transmissibility, and immune escape.

The Philippines has implemented a 15-day travel restriction until May 14 on inbound passengers from India, Nepal, Pakistan, Bangladesh, and Sri Lanka.

The DOH called on local authorities to implement stricter border control to prevent a local transmission of the said variant.

 

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