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FDA: Emergency approval for COVID-19 vaccine possible in January
Gaea Katreena Cabico (Philstar.com) – December 3, 2020 – 4:24 pm
MANILA, Philippines – The country’s Food and Drug Administration could grant an emergency clearance to top coronavirus vaccine candidates in January at the earliest, its boss said Thursday.
This, if drug manufacturers developing COVID-19 vaccines apply for an emergency use authorization (USA) with the local FDA in the short term.
“If they ask us during the first weeks of January, we will be able to provide USA and arrive a little earlier, have a chance in March, have a vaccine here in the Philippines,” said FDA Director General Eric Domingo at a briefing by the palace.
(If you submit your application, we may already be able to issue USA by the first weeks of January. Perhaps there will already be a vaccine here in the Philippines by March).
President Rodrigo Duterte signed an executive order Tuesday giving the FDA the power to issue US for COVID-19 vaccines and treatments, shortening the regulatory approval process from the usual six months to just 21 days.
US applicants in the Philippines must have an equivalent emergency authorization from the countries where they were developed, the counterpart regulatory body, or the World Health Organization.
If applicants submit all necessary documents, the vaccine safety and efficacy review will be completed within 21 to 28 days.
Process
In a separate briefing organized by the Department of Health, Domingo said US applications will be sent to the local FDA.
The agency’s Center for Drug Regulation and Research will assess the quality of the candidate vaccine, while a panel of experts will conduct a review of the safety and efficacy data of COVID-19 vaccines or drugs.
Domingo also said the FDA, in conjunction with the DOH Office of Epidemiology, will establish “very strong” post-authorization monitoring to track the effects of the vaccine or drug on the public once it is administered.
“We would like to assure the public that we will take it very seriously, that we will make sure that the benefits outweigh the risks more than anything before we even consider administering EUA to any vaccine and of course it will come with many conditions to ensure we safeguard safety from the public, ”said Domingo.
China is allowing the emergency use of vaccine candidates from Sinovac and Sinopharm. The United Kingdom granted emergency authorization to Pfizer’s coronavirus vaccine, ahead of the United States. Moderna, another pioneer in vaccines, also applied to the US FDA for the US.
Domingo said these four vaccine developers along with AstraZeneca could be the first to apply for emergency use in the Philippines.
If granted, an emergency authorization will only be valid within the duration of the public health emergency due to COVID-19. The FDA may also revise or revoke the EUA “to protect the health and safety of the general public.”
With more than 430,000 COVID-19 cases and 8,000 deaths, the Philippines is struggling to obtain vaccine supplies to help end one of the worst outbreaks in Southeast Asia.
The country, thanks to the efforts of some 30 private companies, has so far obtained 2.6 million doses of the COVID-19 vaccine developed by Astrazeneca. The British-Swedish developer said that the average efficacy of its vaccine candidate was 70%. – with report from Xave Gregorio
How does it happen
LAST UPDATED: December 2, 2020 – 3:42 pm
Pharmaceutical giants Sanofi and GSK said on July 29, 2020 that they agreed to supply Britain with up to 60 million doses of a possible COVID-19 vaccine. The agreement covers a candidate vaccine developed by France’s Sanofi in association with Britain’s GSK and is subject to a “final contract”.
This thread compiles some of the main advances in the search for a vaccine to alleviate the new coronavirus pandemic. (Main photo by AFP / Joel Saget)
December 2, 2020 – 3:42 pm
Britain’s approval of BioNTech-Pfizer’s vaccine against COVID-19 marks a “historic moment” in the battle against the pandemic, the chief executive of the US pharmaceutical group said on Wednesday, after his company obtained the first authorization from this guy in the West.
“Today’s emergency use authorization in the UK marks a historic moment in the fight against COVID-19,” says Albert Bourla, Chief Executive Officer of Pfizer.
The US company and the German company BioNTech add that they expect new regulatory decisions from other countries “in the coming days and weeks.” – AFP
December 2, 2020 – 3:20 pm
The UK approves the Pfizer-BioNTech vaccine for launch “next week”.
Britain on Wednesday becomes the first country to approve Pfizer-BioNTech’s COVID-19 vaccine for general use and says it would be introduced next week.
“The government today accepted the recommendation of the Medicines and Healthcare Products Regulatory Agency (MHRA) to approve the use of the Pfizer-BioNTech Covid-19 vaccine,” the health department said in a statement.
“The vaccine will be available across the UK from next week,” the statement says, and priority groups include nursing home residents, health and care staff. – AFP
December 2, 2020 – 2:41 pm
President Rodrigo Duterte grants authority to the Food and Drug Administration to issue an emergency use authorization for COVID-19 vaccines, says Executive Secretary Salvador Medialdea.
Duterte Executive Order 121 also allows the FDA to release emergency use authorization for COVID-19 drugs, prescription conditions, and for other purposes.
December 2, 2020 – 8:15 a.m. M.
The Pfizer and Moderna COVID-19 vaccines could be approved in a matter of weeks, but who will get them first in the United States?
A high-level panel of American experts voted Tuesday that healthcare workers and residents of long-term care facilities should take priority in the first phase.
“I believe that my vote reflects the maximum benefits, the minimum harm, the promotion of justice and the mitigation of inequalities in health that exist, with respect to the distribution of this vaccine,” said José Romero, president of the Advisory Committee on Practices of Immunization of the Centers for Disease Control. and Prevention.
Yet as the sequence continues, US experts may differ from other countries in prioritizing the “critical workers” who keep society going, potentially even before those most at risk. – AFP
December 1, 2020 – 8:45 pm
The European Medicines Agency (EMA) said on Tuesday it will hold an extraordinary meeting on December 29 “at the latest” to consider emergency approval for a COVID-19 vaccine developed by Germany’s BioNTech and US giant Pfizer.
“If the data presented is robust enough to reach a conclusion on the quality, safety and efficacy of the vaccine, the EMA … will conclude its evaluation during a special meeting scheduled for December 29 at the latest,” he said. the EU regulator in a statement.
Pfizer and BioNTech previously announced that they had formally applied for conditional EU approval for their jab, following a similar request in the United States. – AFP
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