COVID-19 surge hastens vaccine development

The renewed surge of the COVID-19 pandemic has hit countries across the world, with the number of cases globally spiking to 55.86 million and deaths due to the disease, at 1.33 million. Worst hit is the United States, with nearly 11.5 million recorded cases (155,000 a day) and 250,000 deaths (over 1,100 a day).

That’s very bad news by any measure.

However, there has been a positive twist to the surge. It has accelerated the last phase of trials (Phase 3) being conducted by the multinational pharmaceutical firms racing to develop an anti-COVID-19 vaccine. It enabled the vaccine-testing firms to increase participants in their trials. And the faster that participants get sick, the faster the drug firms accumulate enough data to know whether their candidate-vaccines are effective.

The Phase 3 trial ends after the testing firms have accrued a certain number of cases (150 to 170), being assured the results have enough “statistical power” to tell how well the vaccine works, per a report by the New York Times last Thursday.

However, two American pharmaceuticals using the same brand-new technology – Pfizer (partnering with the German firm BioNTech) and Moderna – announced early this week that their candidate-vaccines are 95 percent effective. In the case of Moderna, it had planned on finishing with only 53 cases of COVID-19 to turn up for experts to begin looking at the data. But the surge in infections in the US enabled it to easily reach 95 sick participants. Similarly, Pfizer’s data covered 94 participants, nearly three times the number it had originally targetted, the NYT reported. But an Al Jazeera report quoted by PhilStar yesterday said that Pfizer-BioNTech had accumulated 170 infection cases.

Pfizer-BioNTech said they are preparing to formally ask the US Food and Drug Administration to allow emergency use of their vaccine. They have also begun what they called “rolling submissions “ for their vaccine’s use with regulators in the European Union, the United Kingdom and Canada.

US health and human services secretary Alex Azar was quick to say about the Pfizer and Moderna vaccines: “We now have two safe and highly effective vaccines that could be authorized by the (FDA) and ready to distribute within weeks.”

But note the cautionary statement of BioNTech co-founder and chief executive officer, Dr. Ugur Sahin, and that of US FDA adviser Dr. Paul Offit.

Sahin said, “The available vaccine doses are just too small to ensure that we could make a significant difference to society (outrightly).”  However, if by next year the candidate-vaccines of several other companies also prove to be effective, “we might be able to get control of this pandemic situation (by) late summer 2021.” While initial supplies will be scarce and rationed, he noted, the supplying drug firms have a responsibility to help ensure that lower-income countries (such as the Philippines) shall have access to the vaccines.

The US government has made previous arrangements with Pfizer and Moderna to ensure that, initially, there would be vaccines available to inoculate 20 million Americans, with the Center for Disease Control and Prevention deciding who would be vaccinated first, expectedly health workers and the elderly.

On the other hand, Dr. Offit said that while “there’s every reason to be enormously optimistic,” he added: “When these vaccines roll out, you’re only going to know it’s effective for a limited period of time.” Which may mean repeated innoculation of the same vaccine. More follow-up information will have to come, he said.

Meantime, the UK’s Oxford University and AstraZeneca vaccine development tandem has made it known that the early results of its trials, published in the Lancet medical journal, show that their candidate-vaccine stimulates an immune response in older adults (from 56 years old to the 70s) as good as the response among younger people. There were also fewer side effects reported in older people than in younger ones.

Oxford vaccine group chair Andrew Pollard said that they are not competing with Pfizer-BioNTech and Moderna, so they are not rushing to publish the efficacy results of their anti-COVID-19 vaccine trial. Nonetheless, he said, “We’re optimistic we will be able to do so before Christmas.”

Already, the British government has ordered 100 million doses of the Oxford-AstraZeneca vaccine, although it had also pre-ordered 40 million doses of Pfizer-BioNTech’s version and five million doses of Moderna’s, reported the Guardian. The UK vaccine, the report pointed out, is likely to be priced much cheaper than those of the two American brands. Moreover, the UK vaccine can be stored in ordinary refrigerators, rather than in freezers – thus easier for worldwide use.

Weighing in on these developments, the World Health Organization has emphasized that “there’s an enormous amount of work to do and resources that will be needed to actually deliver the vaccines to everybody who needs them,” should these in fact be made available, as “the press releases indicate.”

Kate O’Brien, WHO director for immunization and biologicals, warned that Pfizer’s vaccine poses a challenge to low-income countries because it has to be stored in a freezer with temperature of minus-70 degrees Centigrade or lower. Moderna’s version, however, she said, can be kept at a standard refrigerator temperature of between two and eight degrees Centigrade.

WHO chief scientist Soumya Swamanathan pointed out that there will be “very, very limited doses” of the vaccines during the first half of 2021. Many of the drug firms testing vaccines have made bilateral deals with some countries, she notes, however expressing hope that enough doses would be appropriated for the WHO-sponsored Global COVAX facility (in which the Philippines is participating).

Such is the situation under which the Philippines must urgently adopt and pursue a program to procure any of the candidate-vaccines that finally may be authorized by the US FDA and other countries’ regulators for procurement and use. In this regard, President Duterte has finally agreed to advance supply agreements and to make early payments to the vaccine manufacturers that may be selected.

The huge funding requirement has to be determined and resolved as soon as possible. The government’s proposed 2021 annual budget calls for a measly P18-billion funding for vaccines, which Senate president pro tempore Ralph Recto urged to be raised up to P100 billion or more. Meantime, several big businesses and organizations are working on a “tripartite agreement” with the government and a pharmaceutical firm towards donating the agreed-on vaccine(s).

This is a fine gesture of goodwill, one that’s appreciated by a public tired of sourgraping, badmouthing and other negativities being spewed like COVID droplets.

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