Following Russia's announcement of the registration of the world's first anti-coronavirus vaccine, the Financial Times broke that US President Donald Trump considered fast-tracking UK-Swedish AstraZeneca's COVID-19 drug AZD1222 before the US election. Citing three unnamed people briefed on the plan, the media outlet alleged that the company's product could be granted an Emergency Use Authorisation (EUA) on the basis of a 10,000-subject Phase 3 clinical trial. Back in May, the US administration and AstraZeneca negotiated the delivery of at least 300 million doses of AZD1222, with the first batch possibly supplied as early as in October 2020 under Trump's Operation Warp Speed.
However, the British-Swedish drug maker shredded the FT report by saying that the speculations are "premature" and that it is neither in talks with the US government over the emergency use authorisation of its potential anti-COVID vaccine, nor does the company "anticipate efficacy results until later this year".
Development of Vaccine Highly Politicised Amid 2020 Election Race
Judging from Trump's 22 August tweet, the US president is really striving to get vaccines and other anti-COVID medicines as soon as possible and suspecting the "deep state" of throwing a wrench into his gears.
"The deep state, or whoever, over at the [Food and Drug Administration, FDA] is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics", he wrote. "Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!"
The debate over the apparent politicisation of the anti-COVID vaccine has been simmering in the US for the past few months. While Trump is lambasting Operation Warp Speed's opponents for putting American lives at risk by delaying the vaccine's release to diminish his election odds, the left-leaning media and politicians are claiming that the incumbent president wants to turn the vaccine into a "campaign stunt" at the cost of American lives.
"With the 2020 presidential election approaching, the pandemic and development of a vaccine are being politicised by partisanship on both sides that actually puts the public health at greater risk", admits Max Parry, a US independent journalist and geopolitical analyst.
Trump obviously has taken a great deal of criticism for his handling of the pandemic and would likely benefit from the availability of a vaccine before the election, according to the American journalist. Parry observes that "it isn't necessarily a vaccine per se that would score points for Trump, but a reduction in the severity of the outbreak in the United States in any form, which has been far and away the worst of any country".
For the very same reason, the Democrats "are likely to characterise the debut of any vaccine before November as hasty, whether it is actually hurried or not", as they "have been hinging a great deal of Joe Biden's chances upon the widespread perception that Trump has mishandled the crisis".
Thus, in June, The New York Times published an op-ed by Ezekiel J. Emanuel, an oncologist and former White House adviser, and Paul Offit, professor of paediatrics and co-inventor of a rotavirus vaccine, who warned against Trump's "warp speed" approach towards anti-COVID vaccination. Though AstraZeneca earlier pledged to roll out its vaccine in October, one should not rush to get one but test it thoroughly, the op-ed warned.
Meanwhile, on 24 August, Democratic leaders of the House Committee on Energy and Commerce wrote a letter to the FDA urging it not to succumb to President Trump's pressure with respect to fast-tracking any anti-COVID drugs. "We all want a safe and effective COVID-19 vaccine as soon as possible", the Democratic officials insisted, adding however, that they highly appreciate the FDA's stance of making any potential vaccine candidate available only after thorough trials, which means that it "will be unlikely before spring 2021".
"We already saw this exact same situation play out with the controversy over Trump's touting of the anti-malaria drug hydroxychloroquine", Parry underscores. "The casualty of this factionalism in Washington is the public's already waning trust in the US political system on both sides of the aisle, where not even during a national health crisis can partisan politics be put aside".
Russia's Sputnik V & Operation Warp Speed
While the observers are unsure whether AstraZeneca is dancing to the anti-Trump camp's tune or really needs more time to make sure its vaccine is efficient and safe, they admit that currently the only officially registered anti-COVID vaccine is Russia's Sputnik V, developed by the Gamaleya National Research Centre.
Like AstraZeneca's AZD1222, Russia's anti-coronavirus drug is based on the well-known adenovirus platform with two major differences: first, Gamaleya scientists use human adenoviruses which have proven to be safe, not affecting fertility and not heightening a cancer risk; second, Sputnik V is administered in two shots, which improves the vaccine's efficiency, according to the developers.
Once Sputnik V was registered on 11 August, American politicians and healthcare officials, including "COVID Czar" Dr Anthony Fauci, rushed to denounce Moscow's vaccine and accuse Russian scientists of cutting corners on clinical trials. CNN claimed that the Russians approached US officials offering help under Operation Warp Speed, but were rebuffed.
"Dr Fauci has hardly covered himself in glory with regard to COVID-19, or for that matter, with Dr Birx, on HIV/AIDS", notes Wall Street analyst and investigative journalist Charles Ortel. "Science should be a field where advances are welcomed, and evaluated, by qualified experts drawn from across the planet. History demonstrates that Russians have made large contributions to science over long periods of time".
Addressing soaring scepticism in the Western MSM, Gamaleya scientists explained that the high-speed of development of Sputnik V is by no means surprising given the institutes' decades-long research in the field of adenovirus-based drugs and a successful development of anti-Ebola and anti-MERS vaccines. The latter coronavirus, MERS-CoV, has similarities with SARS-CoV-2, which causes COVID-19, according to them. On 26 August, the Gamaleya Centre kicked off large-scale Phase 3 trials which will involve 40,000 volunteers. According to the institute's head, Alexander Gintsburg, the anti-COVID mass vaccination programme in Russia may start as early as in October or even mid-September 2020.
Hypothetically, the Trump administration could have picked the Russian vaccine for EUA, but imagine how his opponents would react, Parry remarks.
"Trump is already being persecuted politically by the foreign policy establishment in Washington for merely suggesting the idea of detente with Moscow and his perceived ingratiation with his Russian counterpart, so assuming Sputnik V proves to be effective, if his administration were to approve distributing it as part of Operation Warp Speed it would inevitably set off another round of hysteria around Trump and Russia in the US media and Washington", the journalist underscores.
For his part, Charles Ortel expresses hope that "Operation Warp Speed will evaluate all potential advances carefully without regard to national origin". An effective and safe anti-COVID vaccine would help reopen and revive the economy, he stresses, adding that "Americans are hungry for jobs''. According to him, American politicians should encourage the best scientists worldwide to work together rather than poisoning the process of getting safe and lasting cures.
Bold results of Sputnik V in fighting the pandemic would likely cause enormous scandals as it would mean that Western governments let people needlessly die from the outbreak by snubbing the Russian anti-COVID drug due to the politicisation of the issue, Parry concludes.