As COVID-19 Vaccines Approach WHO Cautions Against Remdesivir
Last week Pfizer and German partner BioNTech became the first companies to seek emergency authorization for the COVID-19 (Coronavirus, 2019) vaccines in the United States. Data released on November 9th showed the vaccine they are working on being quite effective. Shortly after, Moderna also announced similar results providing a major step forward in the battle against the virus.
The following data outlines the efficacy of the Pfizer and BioNTech vaccine:
- Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose;170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group
- Efficacy was consistent across age, gender, race, and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%
- Safety data milestone required by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved
- Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%
- Companies plan to submit within days to the FDA for EUA and share data with other regulatory agencies around the globe
- The companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021
On Monday morning, AstraZeneca and Oxford University released data regarding their COVID-19 vaccine, “…Interim analysis from its phase three vaccine trial shows that the 70% effectiveness comes from combining two-dose regimes. One was 90% effective, the other 62%.”
“These findings show that we have an effective vaccine that will save many lives. Excitingly, we’ve found that one of our dosing regimens maybe around 90% effective and if this dosing regime is used, more people could be vaccinated with planned vaccine supply,” said Professor Andrew Pollard, director of the Oxford Vaccine Group and chief investigator of the Oxford Vaccine Trial.
The news comes a day after Dr. Moncef Saloui spoke on CNN’s State of the Union show regarding the Pfizer vaccine. “By December 11 or 12, I’m hopeful the first people will be immunized across the US, in all states,” he said on the program.
Dr. Saloui added that at least 70% of the United States population would need to receive the vaccine for “true herd immunity to take place,” before adding, “That is likely to happen somewhere in the month of May, or something like that based on our plans. I really hope and look forward to seeing … people’s acceptance of the vaccine increasing. That’s critical.”
This positive news comes after the World Health Organization (WHO) released a memo to journalists warning nations and their citizens against taking the drug Remdesivir to combat COVID-19. The antiviral medication is sold under the brand name Veklury, is an investigational drug, and has never been used to treat a condition.
A portion of the memo reads:
After thoroughly reviewing this evidence, the WHO GDG expert panel, which includes experts from around the world including four patients who have had covid-19, concluded that Remdesivir has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement.
The memo stated there isn’t any evidence to show Remedesivir improves the condition of patients who are battling Coronavirus, “…Given the remaining possibility of important harm, as well as the relatively high cost and resource implications associated with Remdesivir (it must be given intravenously), they [WHO GDG panel] judged this to be an appropriate recommendation,” the memo continued.
All related news comes after 141,641 new COVID-19 cases were reported in the United States on Sunday after the country recently passed 12 million total cases since the beginning of the pandemic earlier in 2020.
Illinois (168,413), Texas (154,332), California (137,043), Michigan (99,472), and Ohio (97,559) have seen a drastic number of COVID-19 cases between November 8th – November 21st. Florida (94,750) also sits over 90,000 cases during the period.
While the vaccine news shows Coronavirus will one day be under control, a lot of damage is still yet to come due to many refusing to wear masks and respect social distancing guidelines.