President Donald Trump has previously made several promises that the country will have a COVID 19 vaccine “very soon”, including by election day.
But on November 3, all vaccine candidates worldwide are still in the preclinical and clinical evaluation stage, according to the latest report from the World Health Organization (WHO) on Tuesday. These include several that are being developed by companies in the U.S., none of which have applied for approval of their vaccine candidates.
In September, Trump said: “So we will have a vaccine very soon, maybe even before a very specific date. You know what date I’m talking about,” Trump accused the Food and Drug Administration (FDA) and health experts at the U.S. Center for Disease Control and Prevention (CDC) of playing politics with the goal of election day.
Back in August, during an interview with Geraldo Rivera, the president said in Geraldo Rivera’s Roadwill podcast that “in some cases” a vaccine could be ready before the election.
“I think in some cases, yes, it could be ready before [the election]. But around that time,” Trump told Rivera. “We have great companies,” Trump said. We have great companies. These are the largest companies in the world. And the rest of the world makes vaccines, too. So let’s see how they do.”
On Friday, White House Director of Strategic Communications Alyssa Farah noted that the President’s promise to deliver a vaccine by November 3 was “a kind of arbitrary deadline.
Farah told reporters: “We have nearly half a dozen vaccines in Phase Three clinical trials, which for a novel virus like the one we have, is a record time to get it there.
“We remain very confident that we will have a vaccine by the end of the year and are ready to make it available to one hundred million Americans.
“His [trump card]goal has never been – election day is a kind of arbitrary deadline,” she said.
Latest development of the COVID-19 vaccine in the USA
Worldwide, 47 vaccine candidates are in the clinical evaluation stage, 10 of which are in phase three trials, while according to the WHO 155 candidates are still in the preclinical evaluation stage.
Among the potential vaccines in the third phase of clinical trials is one being developed by Pfizer, the major pharmaceutical company based in New York City, in collaboration with BioNTech, a biotechnology company in Germany.
Last month, Pfizer announced that it could file for safety approval with the FDA as early as the third week of November, “provided positive data from recent studies are available,” said Albert Bourla, Pfizer’s Chairman and Chief Executive Officer (CEO), in an open letter.
“In the event of an emergency approval in the U.S. for a potential COVID 19 vaccine, the FDA requires companies to submit two months of safety data on half of the study participants after the last dose of the vaccine.
“Based on our current study recruitment and dosing pace, we expect to reach this milestone in the third week of November. Safety remains our top priority and we will continue to monitor and report safety data for all study participants for two years.
“So let me make it very clear: assuming positive data, Pfizer will apply for emergency approval in the U.S. shortly after reaching the safety milestone in the third week of November,” said Bourla.
In September, the company announced that it would apply to expand its Phase 3 study to “approximately 44,000 participants, which will also allow the inclusion of new populations,” the company stated in a statement at the time.
On October 22, the Massachusetts-based biotechnology company Moderna completed recruitment of 30,000 participants for the Phase 3 study of mRNA-1273, with the vaccine candidate COVID-19 being developed in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).
“Moderna will decide whether to submit a dossier to the FDA for emergency approval based on an assessment of whether the potential benefits of the vaccine outweigh the potential risks once the two months of median safety follow-up have passed,” Moderna said in a statement last month.
Last week, Moderna confirmed that it is on track to report interim data from its last study this month, Reuters reported.
U.S.-based Johnson & Johnson, which last month suspended its clinical trials of its vaccine candidate COVID-19 due to an “unexplained illness” in one of its participants, recently announced that it is preparing to resume recruitment for its Phase 3 study.
“After a thorough evaluation of a serious medical event that occurred in one study participant, no clear cause could be identified. There are many possible factors that could have caused the event.
“Based on the information gathered to date and input from independent experts, the Company has found no evidence that the vaccine candidate could have caused the event,” the Company said in a statement on October 23.
Already at the end of September, the Maryland-based biotechnology company Novavax started the third phase of its NVX-CoV2373 vaccine trial, which is being conducted in the UK in collaboration with the UK government’s Vaccines Taskforce, the company confirmed in a statement.
Last Thursday, during a live chat on Twitter and Facebook, Dr. Anthony Fauci, director of NIAID, noted that Americans are likely to “know sometime in December whether or not we have a safe and effective vaccine”.
“The first interim review [of the study results]should, we hope, take place in the coming weeks,” Fauci said.
Last month, U.S. Secretary of Health and Human Services Alex Azar said: “In anticipation of FDA approvals, we believe we could have up to 100 million doses by the end of the year – enough to cover particularly vulnerable populations – and we expect to have enough for every American who wants a vaccine by March to April 2021”.