In a letter dated August 27th, Robert Redfield, the director of the U.S. Centers for Disease Control and Preventions, said U.S. states will receive permit applications in the near future from McKesson Corp., which has contracted with the CDC to distribute vaccines to places including state and local health departments and hospitals.
U.S President Donald Trump has also forecasted a U.S. vaccine approval by October.
So, who is in the race of developing America’s Covid-19 vaccine? The three leading drug makers backed by the U.S. in late-staging testing now are Moderna, Pfizer and AstraZeneca.
Moderna CEO, Stephane Bancel, said that they should have enough data from its late-stage trial to know whether its vaccine works in November. The Cambridge, Massachusetts-based biotechnology company also became the first to publish the blueprints of its study following public pressure for greater transparency. Moderna’s Covid-19 vaccine enters the final stage trial this month.
As of September 19th, Moderna had recruited 25,296 volunteers. Among them, 10,025 had received their second dose, 28 days after the first. It’ll take a few more weeks to recruit the full quotient of 30,000 participants and for them to receive their second doses. Only Covid-19 infections recorded two weeks or more after the second dose are counted, to give the vaccine sufficient time to take effect.
Pfizer CEO, Albert Boula said its vaccine could be distributed to Americans before the end of the year, citing that the company should have key data from its late-stage trail by the end of October, which is line with what U.S President Donald Trump’s wants. Currently at phase 3 trials, Pfizer also published the blueprints for its research, soon after Moderna’s move.
While Pfizer is a household name in pharmaceuticals, it’s also a collaborating with a lesser known Biopharmaceutical New Technologies. Pfizer and BioNTech are planning to expand the enrollment of their phase 3 COVID-19 vaccine trial from 30,000 to 44,000 participants.
AstraZeneca co-developed a vaccine with the University of Oxford, but the global trials for it were suspended last week after a study volunteer, a previously healthy 37-year-old woman “experienced confirmed transverse myelitis” after receiving her second dose of the vaccine.
AstraZeneca has since announced that it will pause the the trial worldwide. The trial resumed in the U.K. on Saturday but is yet to resume in the U.S. Communications about the patient’s condition has not been fully transparent too, citing a company spokesperson that they “cannot disclose medical information.”
Trump said a vaccine could be three or four weeks away, despite cautionary warnings by U.S public health officials about that accelerated timeline.
Trump, speaking at a town hall hosted by ABC News in Philadelphia, defended his handling of the coronavirus crisis, and said a vaccine could be ready for distribution before the US presidential election on Nov 3.
“We’re very close to having a vaccine,” he said.
“If you want to know the truth, the previous administration would have taken perhaps years to have a vaccine because of the FDA and all the approvals. And we’re within weeks of getting it … could be three weeks, four weeks.”
U.S Democratic presidential candidate Joe Biden contradicted Trump, warning Americans that they cannot trust the president’s word. The president has since hit back at Biden, accusing him of spreading “anti-vaccine rhetoric”.
Stages of the race
The vaccines are usually tested on animals first to assess the safety and also its effects on the immune system. In order to pacen the process, researchers have tested both and animals and humans together.
Clinical Trials (Phase 1)
Vaccine is given to a group of people (usually between 10-50)
Clinical Trials (Phase 2)
Further tests are then administered on hundreds of people.
Many coronavirus vaccines combine both phase 1 and 2 trials, which means that it is directly tested on hundreds of people instead in its supposing first phase.
Clinical Trials (Phase 3)
Thousands of people across different ages and locations are then given the vaccine; researchers later observe on how many contact the virus then. This shows how good it is at reducing new infections.
The trial results are then reviewed by regulators who then determine whether it should be approved for licensing and large-scale manufacturing
Each step can typically take up to two years or more to complete, but the race has since forced some companies to combine or skip steps to accelerate the process.
Operation Warp Speed
The U.S. government has stood by an “America First” approach to finding a vaccine. The Operation Warp Speed initiative is an effort largely similar in purpose with the mission to get a man on the moon. Launched in May this year, it aims of delivering 300 million “safe, effective’ doses by January 2021; eight of the most promising vaccine candidates has been selected and given a boost by the U.S. government.
$10.8 billion has been dedicated for vaccine development and procurement while $1.5 billion has been pumped in for manufacturing and distribution.