Drugmaker AstraZeneca announced on Monday that its experimental coronavirus vaccine has shown an average efficacy of 70% in large-scale trials — the latest of several vaccine trials worldwide to post their results this month.
The news follows Pfizer and BioNTech announcement Friday that they submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate. The agency could make a decision early next month about whether to issue an emergency use authorization, according to a source.
Here’s a look at the major developments announced by Covid-19 vaccine makers:
- Nov. 20: Pfizer submitted their application for emergency use authorization to the Food and Drug Administration.
- Pfizer announced last week that its vaccine has a 95% efficacy rate. They included more data than they have before – looking at 170 confirmed cases of Covid-19, and they said it has 94% efficacy for people 65+.
- Dec. 10: The FDA advisory committee will meet to discuss Pfizer’s EUA application.
- If given a green light, the CDC’s vaccine advisory committee will meet within 24-48 hours and make a recommendation on who should be first to get the vaccine. Shots in arms are expected to begin after that recommendation is made, likely on determination of priority.
- Based on current projections, Pfizer expects to produce up to 50 million vaccine doses in 2020, and up to 1.3 billion doses in 2021. They have not said how much of that would be for the US.
- Pfizer said last week it would test distribution of its coronavirus vaccine candidate in four states to see how hard it will be to deal with a product that has to be kept at temperatures well below the capacity of standard freezers.
- Nov. 17: Moderna announced efficacy results from a data safety monitoring board (DSMB). Initial results show 94.5% efficacy, with no significant side effects.
- FDA and CDC will make their determinations and recommendations, similar to the process outlined above for Pfizer.
- Moderna expects to have 20 million doses ready for the US by the end of the year.
- Same timeline as outlined by Dr. Anthony Fauci for Pfizer.
- Nov. 23: AstraZeneca announced their vaccine candidate has shown an average efficacy of 70%.
- This week: The company will show data to the FDA and regulators in Europe.
Johnson & Johnson
- Nov. 19: Johnson & Johnson announced they expect efficacy results by January or February of 2021.
- The trial expects to reach its enrollment goal of 60,000 participants by the end of the year.
- Nov. 9: The vaccine maker announced last week it received fast-track designation from the FDA for its vaccine candidate.
- Novavax expects to begin its Phase 3 trial in the US and Mexico by the end of November. The vaccine candidate will require two doses with hopes to deliver 100 million units by the end of the year.
- Nov. 12: Biopharmaceutical company Medicago and GlaxoSmithKline announced that Phase 2/3 clinical trials are set to begin for a Covid-19 vaccine candidate.
- The trial evaluates the efficacy, safety and immunogenicity of Medicago’s experimental vaccine combined with GlaxoSmithKline’s booster.
- The Phase 3 part of the study will start before the end of this year and will evaluate the efficacy and safety of the vaccine candidate compared to a placebo in more than 30,000 subjects across North America, Latin America and/or Europe and within the same population – or a broader one pending approval by regulatory authorities.
Hartsfield-Jackson Atlanta International Airport – the world’s busiest – is expecting 1.1 million passengers around the Thanksgiving holiday, down 1/3 from Thanksgiving last year, airport officials said Monday.
The airport’s general manager John Selden said the busiest day of the period – which begins today and goes through the weekend — will be Sunday, where some 190,000 passengers are expected to pass through the airport.
Selden also debuted a revamped South Terminal TSA checkpoint that will employ three dimensional CT scanners, which he says will create greater efficiency by reducing the amount of bag searches.
New York City Health Commissioner Dave Chokshi issued caution ahead of the Thanksgiving holiday, warning a major source of Covid-19 spread in the city – and the country – is from small social gatherings.
“A major source is smaller social gatherings, as we head into the holidays knowing that people from different households may be gathering, may be convening, it is so important to stay safe,” Chokshi said.
“Avoid those types of smaller social gatherings if at all possible and if you do have to have them make sure you are following the rules around distancing and wearing masks because those have been major contributors to spread,” he added.
Earlier Mayor Bill de Blasio echoed Chokshi’s guidance, saying “please don’t travel,” but if you do, “take every conceivable precaution.”
Amid a rush of Thanksgiving travel, accelerating infection rates and no significant change in mobility data, “many Americans could take one simple step to protect themselves: Buy a better mask,” Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration, wrote in a Wall Street Journal op-ed on Sunday.
“While there are still some shortages of medical masks, health-care workers have dedicated supply chains,” Gottlieb wrote. “It’s time to revise the guidance to consumers.”
N95 masks and their equivalents offer the best protection against the novel coronavirus, Gottlieb said. If used properly, they can filter out at least 95% of infectious particles. Equivalents include the KN95 from China and the FFP2 from Europe.
Surgical masks are the next best option, which could offer protection of about 60%, Gottlieb said – but quality matters. Many masks sold on Amazon say they are for dust and allergens but aren’t surgical masks. Real medical-procedure masks are cleared by the FDA and offer one of three levels of protection, with a level 2 or level 3 mask generally being best.
Finally, cloth masks are the least protective, Gottlieb said. If it is the only available option, it should be thick, snug-fitting and made of cotton-polyester blends, as these will generally offer more protection.
“But even a very good cloth mask may only be about 30% protective; scarf or bandanna, 10% or less,” Gottlieb wrote.
While it may be more expensive to buy better quality masks, having a few available for high-risk settings can reduce transmission risks, he said. The Department of Homeland Security has also published online instructions for disinfecting and reusing N95 masks, which can extend their life.
“Slowing the current cycle of spread will be difficult,” Gottlieb wrote. “But encouraging Americans to wear higher-quality masks is a simple step that might make a difference.”
The percent of people who tested positive for Covid-19 city wide is at 2.95%, New York City Mayor Bill de Blasio said today – with a seven-day rolling average of 3.06%, he said.
The mayor said the number giving him “tremendous” concern is the new reported cases on a seven-day average, a threshold of which the city has “blown by many times over.”
Starting last Thursday, New York City closed down its public school buildings after the city’s seven-day average reached the 3% positive testing rate threshold. All students transitioned to remote learning.
With regard to new reported cases on a seven-day average, NYC reports 1,381 cases. The city set threshold is 550 cases.
“Clear as a bell,” he said, this “continues to be huge challenge.”
The daily number of people admitted to hospitals for Covid-19 is at 100, under the 200 threshold. The confirmed positivity rate for Covid-19 for those patients is 43.27%.
“That positivity rate has gone up,” he said “that’s a real concern.”
“The 100 patients, too many but again we see an interesting gap here in that that number has not grown consistently so far, we are not out of the woods,” he said.
He added that intensive care units have not been as full as expected.
New York City Mayor Bill de Blasio reiterated that he believes the city is heading toward the “orange zone” designation based on the trajectory of the state’s numbers, and outlined his initial plan for bringing schools back online. In the orange zone, indoor dining and gyms will be closed.
“We can and we will bring back our schools, it will take a lot of work,” he said.
Remember: New York City closed down its public school buildings starting last Thursday after the city’s seven-day average reached the 3% positive testing rate threshold. All students transitioned to remote learning.
The mayor said there is a “strong strong likelihood that in a matter of days the state of New York will determine that NYC is an orange zone according to state standards.”
De Blasio stressed that he is not speaking for the state but is taking the trajectory of their numbers and analyzing them, adding “basing on what the state has said already there’s a likelihood as soon as next week even that NYC will be declared and orange zones.”
“Once that happens we will be in a position to take additional measures to reopen schools,” he said.
The clear protocol for that involves a lot more testing he said, and a very “aggressive” approach, he said.
Testing would be done in advance of children and staff returning to school on top of much more testing throughout the school year.
A lot of details have to be worked out between the city and state he said.
The first focus will be special education, or district 75 schools, followed by youngest grades including early childhood education and then elementary.
He did not elaborate further on the plan.
National lockdown restrictions in England will end next week as scheduled, British Prime Minister Boris Johnson said on Monday.
Gyms, shops and salons will be allowed to reopen but there will be regional tiered restrictions.
“We are not there yet,” Johnson said to members of parliament as he laid out his plans to return to a tiered system after Dec. 2.
Johnson said he plans to lay out which parts of the country is in which tier on Thursday.
Toronto, Canada’s largest city, was placed into lockdown for 28 days on Friday, with officials shutting shops, businesses and restaurants and banning indoor gatherings to curb a growing spike in Covid-19 cases.
Here’s what you need to know about the restrictions:
- The lockdown will begin on Monday in the city and in Peel, a part of the Greater Toronto area to the west of the city center.
- Indoor social gatherings or events that include members of different households will be banned, and outdoor gatherings will be limited to no more than 10 people, Ontario Premier Doug Ford announced.
- Under the lockdown, retail stores will be open for curbside pickup only, and restaurants and bars will be solely able to provide takeaway.
- Certain businesses such as grocery stores and pharmacies will be allowed to open at 50% capacity.
- Wedding services, funerals, and religious ceremonies where physical distancing can be maintained indoors or outdoors will be limited to no more than 10 people, but schools will stay open.
- Other parts of the province will move to higher levels of restrictions on Monday as well, but will avoid a full lockdown.
More than 1,400 new coronavirus cases were reported in Ontario on Friday, taking the province’s total case since the start of the pandemic beyond 100,000.
The region has been battling a rapidly rising rate of infections, with Toronto particularly badly hit; the city broke its record for new infections on Tuesday and has reported several hundred new cases each day this week.
On Tuesday, Canadian Prime Minister Justin Trudeau said the country is “not there yet” when asked whether a new national lockdown would be imposed.
Read more here.
Wall Street started the holiday-shortened week on a strong note as further progress on the Covid-19 vaccine front gives investors more confidence about the outlook for 2021.
Here’s how things looked at the opening bell:
- The Dow rose 200 points, or 0.7%.
- The S&P 500 gained 0.6%.
- The Nasdaq climbed 0.6%.
- US oil prices advanced 1% to nearly $43 a barrel.
The rally comes despite skyrocketing Covid-19 infections around the US and the return of health restrictions that will pressure the economy.
The good news: AstraZeneca announced its experimental coronavirus vaccine showed an average efficacy rate of 70%, making it the third vaccine candidate to show promising results.