WASHINGTON – A panel of experts on Thursday voted to recommend emergency approval of Moderna’s COVID-19 vaccine, paving the way for six million doses to start shipping as soon as this weekend.

The Food and Drug Administration (FDA) is now expected to imminently grant an emergency use authorization or EUA, which would make Moderna’s vaccine the second to be approved in a Western country. The panel voted 20 in favor, none against, with one abstention.

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

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

“Academics have a way of getting involved in details, and what we have done for the last eight or nine hours was to go over the details,” he said.

The meeting came as the number of deaths from the coronavirus quickly approaches 310,000 in the worst-hit country in the world, which this week began vaccinating healthcare workers and long-term care residents with the Pfizer vaccine.

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

Though the level of protection against COVID-19 for both is around 95 percent – far greater than experts had thought was possible – there have now been a handful of people around the world who developed significant allergic reactions after receiving the Pfizer vaccine.

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

The small Massachusetts-based biotech firm teamed up 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 its efforts.

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

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

‘No specific safety concerns’

An FDA review of all available data found there were “no specific safety concerns identified.”

But on Thursday, FDA official Doran Fink said that should an EUA be granted, the agency would issue a beefed-up warning label regarding potential allergic reactions.

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

Moderna was criticized by Stanford expert Steven Goodman because of its plans to offer the vaccine to participants in its trial who received the placebo, even before it would normally be available to their demographic group.

This would deprive the trial of a control group and reduce the quality of data that could be gleaned from it, plus set a bad precedent for future trials, he said.

But Tal Zaks, Moderna’s chief medical officer, defended the proposal. “None of our trial participants would be ‘jumping the line’ ahead of others, because we have clinical trial supplies that in fact would expire and go to waste,” he said, adding many participants were at high-risk, and one person on the placebo group had died from 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 classed as “severe.”

Allergic reactions occurred in 1.5 percent of the vaccinated population compared to 1.1 percent of the non-vaccinated, but none were classed 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 FDA said there was insufficient information to determine that either vaccine was the cause but would continue monitoring.

In a statement, Philippine ambassador to the US Jose Manuel Romualdez said Moderna and another American biopharmaceutical firm, Arcturus – aside from Pfizer – are ready to provide four million to 25 million doses of COVID-19 vaccines to the Philippines.

“I am pleased to report that aside from Pfizer, Moderna and Arcturus are ready to supply four to 25 million of their respective vaccines starting Q3 2021, should the Philippine government find their proposals acceptable,” Romualdez said.

“We are hoping our government will consider the promising candidates of Moderna and Arcturus for inclusion in our country’s pool of anti-COVID vaccines,” he said.

Useless to blame

Romualdez’s statement came after Foreign Affairs Secretary Teodoro Locsin Jr. revealed that the country was supposed to receive 10 million doses of Pfizer’s COVID-19 vaccine by January until “somebody dropped the ball.”

Locsin said he and Romualdez facilitated a deal with US Secretary of State Mike Pompeo to secure Pfizer’s vaccine.

The purchase, Locsin said, was supposed to be funded by the World Bank and the Asian Development Bank.

Romualdez, however, said the Philippines’ deal with Pfizer for the procurement is still “in progress.”

He said the January 2021 delivery date of the vaccines was pushed back to June because other nations finalized deals earlier and the Philippines “did not act quick enough on the Confidentiality Disclosure Agreement (CDA)” for the procurement.

“It’s useless for us to blame people, nothing will happen to us. The bottom line is, we did not act quickly which we all have to accept, and just simply move on,” Romualdez said in an interview on TeleRadyo yesterday.

Sought for comment on Romualdez’s statement, presidential spokesman Harry Roque said “defer to Sec. Galvez,” referring to vaccine czar Carlito Galvez Jr., the chief implementer of the government’s COVID-19 response.

Locsin said all vaccine manufacturers, not just Pfizer, require that they be held “free and harmless” for any harm caused by their vaccine.

“Anyone says the delay was caused by Pfizer requiring that it be held free and harmless for any harm caused by its vaccine. All vaccine makers demand the same free and harmless clause. I mean f****** all. Also Pfizer never demanded downpayment,” he said on Twitter yesterday.

The country’s top diplomat also backed the purchase of COVID-19 vaccines from different countries to overcome vaccine resistance in the country caused by the Dengvaxia controversy.

“That’s what I proposed with breathtaking logic: a mixed offer of all vaccines, some free, some you pay for, to overcome vaccine resistance thanks to Dengvaxia, thereby reducing Filipino native suspicion of anything not Caucasian – and yet BioNTech was invented by Turkish couple,” Locsin said. — Christina Mendez,AFP



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