News

Stanford vaccine expert: 'They do look very safe'

Member of vaccine review panel says the vaccines bring hope but that millions more doses are needed

A person receives a dose of the Pfizer-BioNTech COVID-19 vaccine, which received the Food and Drug's approval for emergency use on Dec. 11. Courtesy © BioNTech SE 2020, all rights reserved.

As initial shipments of COVID-19 vaccines arrive throughout the United States this week and in coming weeks, Dr. Yvonne Maldonado, a Stanford professor who serves on the Western States review panel for the COVID-19 vaccines, envisions the general population could receive the vaccine by spring or summer.

Under the federal rollout plan, Phase 1A calls for the country's estimated 20 million health care workers and 3 million residents of long-term-care facilities to be vaccinated; Phase 1B covers essential workers; Phase 1C will cover the roughly 80 million people who are 65 years and older with underlying medical conditions that make them vulnerable for severe illness from the coronavirus.

Maldonado said that while the nation's current allocation of 100 million doses of the vaccines might seem plentiful, "We do not think that is enough."

If the nation's nearly 330 million people are to receive two doses each, which is necessary to reach 94% or 95% immunity, the country would need about three quarters of a billion doses. Not everyone would want the vaccine, Maldonado noted, but the point is that they should be able to get it should they choose to.

The government is currently in negotiations to purchase more doses. Any hitches that might slow availability of the vaccines would likely be on the manufacturing side.

Help sustain the local news you depend on.

Your contribution matters. Become a member today.

Join

"The supply chain might be an issue," she said.

Maldonado, who is also a liaison to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, said Wednesday that she expected the CDC's review of Moderna Inc.'s vaccine on Thursday, Dec. 17, to be more streamlined than it was for the Pfizer-BioNTech vaccine.

Dr. Yvonne Maldonado, a Stanford University professor, serves on the Western States review panel for the COVID-19 vaccines. Courtesy Stanford Health Care.

On Thursday, the FDA's Center for Biologics Evaluation and Research's Vaccines and Related Biological Products Advisory Committee recommended the emergency use authorization of Moderna's vaccine or anyone 18 years and older by a vote of 20 in favor and one abstention.

"If things go well tomorrow, by Saturday or Sunday we could have the votes from the CDC and allocate the Moderna vaccine for Phase 1B health care workers. Shortly thereafter, in February, first responders and other essential workers could receive the vaccine," she said.

More vaccines could be in the pipeline in 2021 beyond Pfizer and Moderna, she said. Johnson & Johnson's vaccine clinical trials, which tested 30,000 people, including at Stanford, will be completed at the end of this year and could be approved in early 2021.

Stay informed

Get daily headlines sent straight to your inbox in our Express newsletter.

Stay informed

Get daily headlines sent straight to your inbox in our Express newsletter.

Astrazeneca's vaccine is also undergoing trials and could be available in 2021. Two others, by Novavax and Sanofi, are also in process. Technical issues with the Sanofi vaccine could delay the start of its trials until February, she said.

Maldonaldo said that, having extensively reviewed the data on the Pfizer and Moderna vaccines, the most remarkable thing she noticed is the companies' transparency about their data. Based on that data, the vaccines "do look very safe," she said.

At Stanford, many of Maldonado's colleagues are excited about the vaccines. They think the vaccines are "an opportunity to really stem this pandemic," she said.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

Sue Dremann is a veteran journalist who joined the Palo Alto Weekly in 2001. She is a breaking news and general assignment reporter who also covers the regional environmental, health and crime beats. Read more >>

Follow Palo Alto Online and the Palo Alto Weekly on Twitter @paloaltoweekly, Facebook and on Instagram @paloaltoonline for breaking news, local events, photos, videos and more.

Stay informed on important covid news. Sign up for our FREE daily Express newsletter.

Stanford vaccine expert: 'They do look very safe'

Member of vaccine review panel says the vaccines bring hope but that millions more doses are needed

by / Palo Alto Weekly

Uploaded: Fri, Dec 18, 2020, 6:50 am

As initial shipments of COVID-19 vaccines arrive throughout the United States this week and in coming weeks, Dr. Yvonne Maldonado, a Stanford professor who serves on the Western States review panel for the COVID-19 vaccines, envisions the general population could receive the vaccine by spring or summer.

Under the federal rollout plan, Phase 1A calls for the country's estimated 20 million health care workers and 3 million residents of long-term-care facilities to be vaccinated; Phase 1B covers essential workers; Phase 1C will cover the roughly 80 million people who are 65 years and older with underlying medical conditions that make them vulnerable for severe illness from the coronavirus.

Maldonado said that while the nation's current allocation of 100 million doses of the vaccines might seem plentiful, "We do not think that is enough."

If the nation's nearly 330 million people are to receive two doses each, which is necessary to reach 94% or 95% immunity, the country would need about three quarters of a billion doses. Not everyone would want the vaccine, Maldonado noted, but the point is that they should be able to get it should they choose to.

The government is currently in negotiations to purchase more doses. Any hitches that might slow availability of the vaccines would likely be on the manufacturing side.

"The supply chain might be an issue," she said.

Maldonado, who is also a liaison to the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices, said Wednesday that she expected the CDC's review of Moderna Inc.'s vaccine on Thursday, Dec. 17, to be more streamlined than it was for the Pfizer-BioNTech vaccine.

On Thursday, the FDA's Center for Biologics Evaluation and Research's Vaccines and Related Biological Products Advisory Committee recommended the emergency use authorization of Moderna's vaccine or anyone 18 years and older by a vote of 20 in favor and one abstention.

"If things go well tomorrow, by Saturday or Sunday we could have the votes from the CDC and allocate the Moderna vaccine for Phase 1B health care workers. Shortly thereafter, in February, first responders and other essential workers could receive the vaccine," she said.

More vaccines could be in the pipeline in 2021 beyond Pfizer and Moderna, she said. Johnson & Johnson's vaccine clinical trials, which tested 30,000 people, including at Stanford, will be completed at the end of this year and could be approved in early 2021.

Astrazeneca's vaccine is also undergoing trials and could be available in 2021. Two others, by Novavax and Sanofi, are also in process. Technical issues with the Sanofi vaccine could delay the start of its trials until February, she said.

Maldonaldo said that, having extensively reviewed the data on the Pfizer and Moderna vaccines, the most remarkable thing she noticed is the companies' transparency about their data. Based on that data, the vaccines "do look very safe," she said.

At Stanford, many of Maldonado's colleagues are excited about the vaccines. They think the vaccines are "an opportunity to really stem this pandemic," she said.

Find comprehensive coverage on the Midpeninsula's response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.

Comments

Palo Alto Resident
Registered user
Downtown North
on Dec 18, 2020 at 9:18 am
Palo Alto Resident, Downtown North
Registered user
on Dec 18, 2020 at 9:18 am

Is Dr. Maldonado related to the Maldonado's who run the eponymous pizza shop in Mountain View? If so, that is a very accomplished family - awesome pizza and Stanford doctors.


parent
Registered user
Barron Park
on Dec 18, 2020 at 7:55 pm
parent, Barron Park
Registered user
on Dec 18, 2020 at 7:55 pm

Only tenured professors at Stanford get the vaccine first. Front line residents, fellows, and medical students only will receive the vaccine after protests of not being on the priority list.


Local
Registered user
Stanford
on Dec 19, 2020 at 7:27 am
Local, Stanford
Registered user
on Dec 19, 2020 at 7:27 am

I also really enjoy Maldonado's pizza - it's an amazing place, and even more impressive that the family has such an accomplished academic as well. I will get an autograph next time I am there (after the pandemic).


Chris
Registered user
University South
on Dec 20, 2020 at 8:21 pm
Chris, University South
Registered user
on Dec 20, 2020 at 8:21 pm

People 75+ will be in the 2nd group along with the most essential front-line workers including teachers. That should take care of January.


Lee Forrest
Registered user
Crescent Park
on Dec 21, 2020 at 7:09 am
Lee Forrest, Crescent Park
Registered user
on Dec 21, 2020 at 7:09 am

Safe but effective given that the Covid-19 virus is rapidly mutating?

The UK is now in partial lockdown despite mass public innoculations last week & it appears the coronavirus is here to stay.


Cassandra
Registered user
Another Palo Alto neighborhood
on Dec 22, 2020 at 3:45 pm
Cassandra, Another Palo Alto neighborhood
Registered user
on Dec 22, 2020 at 3:45 pm

@Lee: Covid-19, Covid-20, Covid-21, ...


Lee Forrest
Registered user
Crescent Park
on Dec 22, 2020 at 4:03 pm
Lee Forrest, Crescent Park
Registered user
on Dec 22, 2020 at 4:03 pm

>"@Lee: Covid-19, Covid-20, Covid-21, ..."

^ Or Covid-19.1 then Covid-19.2/19.3/ etc.

When an unchecked Covid version 20.1 rears its ugly head, we'll all be checking in with the undertaker.


Anonymous
Registered user
Duveneck/St. Francis
on Dec 22, 2020 at 11:00 pm
Anonymous, Duveneck/St. Francis
Registered user
on Dec 22, 2020 at 11:00 pm

I prefer experts who are not ethnic-focused. While that is one prism through which to view things, when it is the principal way, it is important to also get the main story without constantly bringing up perceived past grievances.


Linda
Registered user
Los Altos
on Dec 26, 2020 at 4:40 pm
Linda, Los Altos
Registered user
on Dec 26, 2020 at 4:40 pm

In all the other countries in the world, they are vaccinating their vulnerable to high risk of death people first. Only in the US, are people jockeying for position and taking vaccines away from people who really need them. People should be ashamed of themselves especially young politicians who know that their likelihood to die from this are so low. People should think if my risk of dying from this is low then I’m basically taking the vaccine away from someone who doesn’t have those odds. As far as I’m concerned, we should just be doing it by age… Over 80’s first, then over 65 and people with high risk factors, then when we get to the younger population, then there should be some determination of who Frontline workers are but only at that point and if supplies are limited. People are making the case that, high exposure people should get it first but the vaccine has not been proven to protect the spread of the disease therefore that logic makes no sense.
At the beginning it made logical sense that the vaccine would protect spread, therefore vaccinating those that are most likely to spread the disease made sense. Now we know that’s not the case so everything should be prioritized on risk of death. Ask any ICU Doctor who makes up most of its patients and they can tell you that it’s older people and people with high risk conditions. Texas and Florida have it right. California should follow and do the morally right thing.


Peter Carpenter
Registered user
Menlo Park
on Dec 26, 2020 at 5:10 pm
Peter Carpenter, Menlo Park
Registered user
on Dec 26, 2020 at 5:10 pm

"In all the other countries in the world, they are vaccinating their vulnerable to high risk of death people first."

Almost every country is vaccinating their front line health care workers first - a wise and morally sound decision.


Lee Forrest
Registered user
Crescent Park
on Dec 26, 2020 at 6:04 pm
Lee Forrest, Crescent Park
Registered user
on Dec 26, 2020 at 6:04 pm

As far as establishing vaccination priorities....

From The Week/Dec. 29 pp.5...

"States will select their own order of priorities for vaccinations, said Dr. Leanna Wen in WashingtoPost.com, and whatever they decide, "many people will be angry." Ethical questions are piling up:
Should people with a higher risk for severe disease, such as the elderly, be prioritized over "those living in conditions rife for infection, such as inmates"? Is a meat-packer more of an essential worker than a teacher? With bodies piling up, "it would be tragic for vaccines to sit, unused while policymakers argue."

So you folks can decide or opine..should jail/prison inmates get priority over vulnerable elders? And who should determine what occupations are more critical to preserve (outside of health care professionals) from the standpoint of surviving the pandemic?


Peter Carpenter
Registered user
Menlo Park
on Dec 31, 2020 at 8:46 am
Peter Carpenter, Menlo Park
Registered user
on Dec 31, 2020 at 8:46 am

"Pfizer now discloses no post vaccination assurances after ONLY 3 weeks."

Pfizer NEVER claimed any efficacy from a single shot. Their clinical trials, submission and EUA were based on two shots.

The UK decision to only give a single Pfizer shot in order to vaccinate more people is NOT justified by the clinical data.


Peter Carpenter
Registered user
Menlo Park
on Dec 31, 2020 at 9:05 am
Peter Carpenter, Menlo Park
Registered user
on Dec 31, 2020 at 9:05 am


"Every potential bad outcome of a Covid vaccine should be weighed against the chance of getting sick or dying from the disease."

"Getting a vaccine appears to be orders of magnitude safer than getting infected with the virus."

"Those of us who communicate about public health have too often failed to be clear during this pandemic. Many Americans wound up being confused about masks, tests and certainly in how we should think about risk. This has not only led to confusion. It likely also led to sickness and death. Let’s do better with vaccines. There’s a real chance we can stop this pandemic in 2021 if we get this right."

Web Link


Peter Carpenter
Registered user
Menlo Park
on Dec 31, 2020 at 12:17 pm
Peter Carpenter, Menlo Park
Registered user
on Dec 31, 2020 at 12:17 pm

"Pfizer has criticised the UK’s decision to lengthen the gap between doses of its Covid-19 vaccine, saying the “safety and efficacy” of the new schedule had not been evaluated, as infections and hospitalisations continued to soar across the UK.

The rare intervention by the US pharma company came amid growing controversy over the move, with GPs complaining that they were having to cancel appointments and reassure anxious patients who had previously been told they needed the second dose to keep them safe.

“[Our] study . . . was designed to evaluate the vaccine’s safety and efficacy following a two-dose schedule, separated by 21 days,” the company said.

“The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design.”

Web Link



Lee Forrest
Registered user
Crescent Park
on Dec 31, 2020 at 1:09 pm
Lee Forrest, Crescent Park
Registered user
on Dec 31, 2020 at 1:09 pm

Curious...what % of the U.S. population would need to be vaccinated in order to assure some vestige of herd immunity AND scientifically speaking, if 100% of the population were to be innoculated, we would never be able to establish whether Covid-19 was actually eradicated or subsided on its own.


[email protected]
Registered user
Mountain View
on Dec 31, 2020 at 2:11 pm
[email protected], Mountain View
Registered user
on Dec 31, 2020 at 2:11 pm

WOW,

I find it interesting that it appears EVERY comment I wrote has been deleted from this page. Talking about censorship when I did not violate any of the terms of use.

[Portion removed. Please read the email we sent to you yesterday regarding your commenting behavior.]


Peter Carpenter
Registered user
Menlo Park
on Jan 1, 2021 at 11:23 am
Peter Carpenter, Menlo Park
Registered user
on Jan 1, 2021 at 11:23 am

Some very useful rethinking by an acknowledged expert:

"Taken together, if we have vaccine doses to distribute in Jan-Apr, it seems increasingly evident that a strategy of getting as many people (particularly high-risk) their first shot ASAP will save far more lives than sticking with the two shot plan," Wachter said, adding, "Far better to have 100M people who are 80% protected than 50M people who are 95% protected, particularly as we are facing a foe that is getting smarter and nastier. Or at least it seems that way to me."

Web Link


Lee Forrest
Registered user
Crescent Park
on Jan 1, 2021 at 12:00 pm
Lee Forrest, Crescent Park
Registered user
on Jan 1, 2021 at 12:00 pm

Don't miss out on the discussion!
Sign up to be notified of new comments on this topic.

Post a comment

Sorry, but further commenting on this topic has been closed.