2 US Vaccine Manufacturers Can Supply PH: Shipped

The Philippines will be able to obtain between 4 and 25 million doses of COVID-19 vaccines from Moderna Inc. and Arcturus Therapeutics Holdings Inc., the Manila ambassador to Washington said on Friday.

US companies would be ready to supply the vaccines from the third quarter of 2021, if the Duterte government considers their proposals acceptable, Ambassador José Manuel Romualdez said in a statement.

“We hope that our government will consider the promising candidates from Moderna and Arcturus for inclusion in our country’s pool of anti-COVID-19 vaccines,” said Romualdez.

A U.S. panel of experts voted Thursday to recommend emergency approval of the Moderna vaccine, paving the way for six million doses to begin shipping as soon as this weekend. US President Donald Trump in a tweet on Friday said Moderna’s vaccine had been approved and that he would. ship immediately, although the U.S. Food and Drug Administration (USFDA) has yet to make any public announcement of its decision.

This makes Moderna’s vaccine the second to be approved in a Western country.

“The Moderna vaccine was approved by an overwhelming majority. Distribution will begin immediately, ”Trump said in a post on Twitter.

At a press conference in Manila, Undersecretary of Health Maria Rosario Vergeire welcomed signs of progress in the vaccine negotiations, but said each candidate vaccine would need to obtain regulatory approval to ensure safety and efficacy. .

The Philippines plans to purchase 25 million doses of a vaccine supplied by China’s Sinovac Biotech for delivery in March. Additionally, the private sector agreed last month to purchase 2.6 million injections of a vaccine developed by AstraZeneca in the country’s first supply deal for a coronavirus vaccine.

Benefits vs risks

The Philippines had missed an opportunity to buy 10 million doses of the vaccine from Pfizer for delivery in January, Romualdez said.

The US panel of experts voted 20 in favor of Moderna’s vaccine, none against and one abstention.

They were asked to answer the question: “Based on the totality of the available scientific evidence, do the benefits of the Modern COVID-19 vaccine outweigh its risks for use in people 18 years of age and older?”

Epidemiologist Arnold Monto, who chaired the live-broadcast discussion, said nothing should be read about the fact that the vote was even more overwhelming than last week in favor of the Pfizer-BioNTech vaccine.

“Academics have a way of getting into the details, and what we’ve been doing for the last eight or nine hours is going over the details,” he said.

Cutting edge technology

The meeting came as the death toll from coronavirus is fast approaching 310,000 in the United States, the world’s worst-affected country, which this week began vaccinating healthcare workers and long-term care residents with the vaccine. Pfizer.

Both pioneers are based on cutting-edge messenger ribonucleic acid (mRNA) technology, which had never been approved before the pandemic, and both are two-dose regimens.

Although the level of protection against COVID-19 for both is around 95 percent, much higher than experts thought possible, there have now been a handful of people around the world who developed significant allergic reactions after receiving the Pfizer vaccine.

The United States, which has recorded more than 17 million cases of the virus, will likely become the first country to approve the Moderna vaccine.

The small Massachusetts-based biotech company partnered with scientists from the US National Institutes of Health on the product and has received more than $ 2.5 billion from the US government for their efforts.

A clinical trial of 30,400 people found it to be 94.1 percent effective at preventing COVID-19 compared to a placebo, with slightly better performance in younger adults compared to the elderly.

Jacqueline Miller, Moderna’s vice president for infectious disease development, said Thursday that there was a strong suggestion that the vaccine also protected most people against infection, which is important from a public health perspective as it would prevent the broadcast.

A USFDA review of all available data found that “no specific safety concerns were identified”.

Caution label

But on Thursday, USFDA official Doran Fink said that if an EUA was granted, the agency would issue an enhanced warning label regarding possible allergic reactions.

This comes after two health care workers in Alaska had such reactions to the Pfizer vaccine and one of them was hospitalized. Two healthcare workers in the UK also had allergic reactions.

Moderna was criticized by Stanford expert Steven Goodman for her plans to offer the vaccine to participants in her trial who received the placebo, even before it was normally available to their demographic.

This would deprive the trial of a control group and reduce the quality of data that could be obtained from it, as well as setting a bad precedent for future trials, he said.

But Tal Zaks, Moderna’s medical director, defended the proposal.

Common side effects

“None of the participants in our trial would be ‘jumping the line’ before others, because we have clinical trial supplies that would actually expire and go to waste,” he said, adding that many participants were at high risk and one person in the group of placebo had died of severe COVID-19.

The most common side effects associated with the drug, called mRNA-1273, were injection site pain, fatigue, headache, muscle pain, joint pain, and chills.

Few of these effects were classified as “severe”.

Allergic reactions occurred in 1.5 of the vaccinated population compared to 1.1 percent of the unvaccinated, but none were classified as severe.

To date, there have been three reports of Bell’s palsy, a facial paralysis condition, most often temporary, in the vaccine group and one in the placebo group.

The USFDA said there was insufficient information to determine that either vaccine was the cause, but will continue to monitor.

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