Category: Covid-19 Vaccine

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Once a COVID-19 vaccine is here it will likely take two doses – TwinCities.com-Pioneer Press

August 29, 2020

Minnesotans will likely need two separate doses of a coronavirus vaccine once one becomes available.

Minnesota is one of a handful of states working with the federal government to determine the best way to distribute vaccines against COVID-19 once they become available.

President Donald Trump has speculated a vaccine will be ready by the end of the year, but Minnesota health officials are being more cautious.

Kris Ehresmann, director of infectious disease and epidemiology for the state Department of Health, said past experiences with mass vaccinations have shown it is better to under promise and over deliver.

Prospective vaccines are already being produced by several manufacturers although they continue to be studied for safety and effectiveness. The U.S. government is funding that effort to help speed the availability of a vaccine once it is proven to work its nicknamed Project Warp Speed.

Minnesota health officials met online with leaders from the Centers for Disease Control and Prevention this week to provide input on who should be among the first to be vaccinated against the coronavirus that has killed 1,810 Minnesotans and sickened at least 73,240. Whenever a vaccine becomes available it will almost certainly be in short supply and high demand early on.

Erhesmann said state health officials recommended essential workers such as health care providers and long-term care staffers should be among the first to receive the vaccine.

Until a vaccine is released, state health officials continue to plead with residents to follow community mitigation measures in place to slow the spread of the coronavirus. They include wearing a mask, maintaining a social distance of six feet, staying home when you are sick and diligent hand washing.

COVID-19 has sickened more than 24.5 million worldwide and killed at least 830,000. In the U.S. more than 178,000 have died and 5.8 million have tested positive.

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Once a COVID-19 vaccine is here it will likely take two doses - TwinCities.com-Pioneer Press

S. Africa May Be First in Region to Produce Covid-19 Vaccine – Bloomberg

August 29, 2020

Photographer: Andrey Rudakov/Bloomberg

Photographer: Andrey Rudakov/Bloomberg

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South Africa may sign a deal to help produce a Covid-19 vaccine, potentially boosting access to immunization on a continent with limited manufacturing capacity.

The Coalition for Epidemic Preparedness Innovations, a global organization funding vaccine development, is considering the Cape Town-based Biovac Institute as a fill-finish site, according to Helen Rees, the chair of the organizations Scientific Advisory Board. The state-owned vaccine company is one of a few in the country that has the capacity to package doses into sterile dispensers if clinical trials are successful.

What we are looking at is partnerships, Morena Makhoana, Biovacs chief executive officer, said in response to questions. Once that is signed, we will be able to make an announcement.

A manufacturing agreement will put Africa on a similar path to other continents, much like the clinical trials are doing, he said.

South Africa is the only country in Africa that hosts several clinical studies. It has 2,000 people in the AstraZeneca Plc and University of Oxford vaccine trial, while Novavax Inc. announced earlier this month its starting a Phase 2b clinical trial. One-fifth of the 60,000 volunteers expected to enroll worldwide in Johnson & Johnsons Covid-19 vaccine trial will be in South Africa, said Glenda Gray, the chief executive officer of the South African Medical Research Council.

With 618,286 confirnmed cases, the country has the worlds fifth biggest outbreak.

For more on the first trial click here

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Covid-19 has really thrown into focus that we have very limited capacity for vaccine manufacturing across the African continent, even in countries like South Africa, said Rees. But theres tremendous interest and we need to have more countries being able to manufacture vaccines.

(Updates with number of infections in 6th paragraph)

Before it's here, it's on the Bloomberg Terminal.

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S. Africa May Be First in Region to Produce Covid-19 Vaccine - Bloomberg

EU working on further COVID-19 vaccine contracts: Merkel – WHTC News

August 29, 2020

Friday, August 28, 2020 6:27 a.m. EDT by Thomson Reuters

BERLIN (Reuters) - The European Commission is working on signing further contracts with drug companies to secure COVID-19 vaccines, German Chancellor Angela Merkel said on Friday.

On Thursday a spokesman had said that the European Commission has made a 336 million euro ($399.5 million) downpayment to British drug maker AstraZeneca to secure at least 300 million doses of its potential COVID-19 vaccine.

"Further such contracts are in the works," Merkel told journalists at a news conference.

(Reporting by Berlin bureau; Writing by Maria Sheahan; Editing by Riham Alkousaa)

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EU working on further COVID-19 vaccine contracts: Merkel - WHTC News

Trump promises a safe, effective vaccine for Covid-19 before year’s end ‘or maybe even sooner!’ So where does that leave the FDA? – Endpoints News

August 29, 2020

On May 19, Principia CEO Martin Babler received an unsolicited email from the other side of the planet. It was Sanofi CEO Paul Hudson, and he wanted to know if Babler had time to hop on the phone.

These were busy, likely stressful days for the freshman Big Pharma chief. The week prior, he had caused a minor intercontinental controversy when he told Bloomberg that the US would get first rights to pre-order of their Covid-19 vaccine because BARDA had invested in it at risk. The words did not sit well in Sanofis home country of France, where both the government and chairman Serge Weinberg viewed the company as something of a national institution. President Emmanuel Macron had summoned Hudson to the presidential palace and, according to some local reports, they were meeting that day.

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Trump promises a safe, effective vaccine for Covid-19 before year's end 'or maybe even sooner!' So where does that leave the FDA? - Endpoints News

Who in the US Should Get the COVID-19 Vaccine First? – Medscape

August 29, 2020

Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.

Editor's Note: Please view Dr Caplan's video, Both Sides Now, with Drs Auwaerter, Rees and Waldman as they further debate the topic, "COVID-19 Vaccine: Which Country Should Get It First?"

This transcript has been edited for clarity.

Hi. I'm Art Caplan, and I'm at the Division of Medical Ethics at the NYU Grossman School of Medicine. One issue that is becoming increasingly divisive and debated among doctors, ethicists, and policymakers is: If we got a vaccine against COVID-19, who in the United States should go first to get it?

Now, why is that an issue? Because even if we got a vaccine approved early next year, it would not be available for everyone right away. Even if you try to manufacture a vaccine in advance so you have a large amount, you still need to get needles and ship the vaccine out to different locations where people can get it. You'd need to train people to administer it, and you need to get informed consent forms and liability forms out there so that people know what they're agreeing to receive.

If you don't have all of that done, then many folks are going to say, "Don't worry about who goes first. I'm not taking this until I'm convinced that it's safe."

We've had a lot of talk about speed and warp speed and racing that isn't helpful to building trust. We want to be talking about racing and going fast and warp speed to a safe vaccine. Assuming we get that and the data come in and something looks like it's fairly effective and very safe, and we have all the distribution handled and the manufacturing handled and so on, we can assume that we might see 30 or 40 million doses.

In a country of 330 million, that leaves many folks not vaccinated. Even if a significant number of people say they don't want it, there is still going to be a lot of push to get it among people who do see the vaccine as one helpful tool in working our way out of this pandemic.

If you look at the discussion, almost everybody including government officials, FDA officials, advisory panelists, and ethicists says the first group that should get this is healthcare workers. They say it, although they're not always clear about why.

One idea is that you need to give it to them because they will keep the healthcare system working, and another is that you need to give it to them because they face risk and they should get rewarded for having done that almost, if you will, a matter of reciprocity by being first to get the vaccine.

Whichever the reason, I think there's something else that's interesting when people all agree that it's healthcare workers, which is the definition of who's a healthcare worker. You could easily get millions and millions of people designated as healthcare workers.

We normally think that it's going to be doctors and nurses who work in ERs and ICUs. If you don't vaccinate technicians, people who clean the rooms, make food, transport patients, provide security, do the laundry, and so on, you're not going to have a functioning hospital. You're not going to have a functioning ICU and you're not going to have a functioning ER.

The definition of healthcare worker, even if we say let's give it there first, doesn't answer the question completely about who's going first. Of the group I just mentioned, all of them have to be handled if you're going to keep your hospital functioning.

You also have first responders who are going to bring the patients to the hospital. At a minimum, you've got police, fire, ambulance drivers, and probably Uber drivers who are involved in transport. I think right there, if we put forward those groups broadly defined, you probably used up the initial first supply of vaccine before you even get to anybody else.

That's an interesting feature of distribution. Just defining "healthcare worker," doing it sensibly, doing it reasonably, and including first responders is probably going to wipe out your initial 10-20 million vaccine doses, particularly if the vaccine requires two doses, which some of them do.

After that, I think we get into a more interesting argument about who should go next, and I favor protecting people and saving lives. If you're going to die if you get infected, that's a reason to try to immunize those people if it provides protection against getting the virus in a way that could harm you. That probably means elderly people in nursing homes, but it also means prisoners. Prisons have been heavily ravaged in our country by COVID-19, ailments, and death.

We also have poor neighborhoods, populations where there's a lot of comorbidity, poor healthcare access. Poor minority groups, Native Americans on reservations, inner-city people, and African Americans in very poor neighborhoods may have to get a designation of going next, even though it might prioritize race, zip code, or geography. That does seem to be the reality of where the harms and the deaths are followed.

Then I think we have a third population, and this starts to become a tradeoff between the likelihood of getting sick and whether the vaccine provides any protection against spread of the disease.In other words, vaccines can help you build up enough immunity so that you don't die if you get infected. They may also protect against shedding virus and infecting others.

It's at this third level where we have to start thinking about the spread of the vaccine. We might decide that instead of trying to protect additional people at risk say, teachers, daycare workers, or others who might legitimately make a claim it might make more policy sense to try to do a protective ring around places like Florida, Houston, Louisiana, or Phoenix, where outbreaks are raging (if there's still raging at that time of the year) and try to contain the spread of the virus, ultimately hoping to save more lives.

If you look at who is going to get the vaccine first, it's popular to answer this with healthcare workers. I think that answer doesn't even cover all healthcare workers broadly defined in a way that I think you have to do it and first responders. We still may have to make choices about who in that group goes first. Even when we address that, we have to trade off saving lives vs containing the spread of the epidemic. Both strategies are valuable and I think we'll have to give some supply toward each purpose.

Now, if that debate interests you and you want to hear more about how we might decide what to do if we had vaccine supply here, took care of our neediest first, but then discussed sharing with other countries, I have an excellent debate coming up on the show that I host, Both Sides Now, with internationally renowned experts who will discuss what's ethical in the distribution of vaccine worldwide.

I'm Art Caplan at the Division of Medical Ethics at New York University's Grossman School of Medicine. Thanks for watching.

Arthur L. Caplan, PhD, is director of the Division of Medical Ethics at New York University Langone Medical Center and School of Medicine. He is the author or editor of 35 books and 750 peer-reviewed articles as well as a frequent commentator in the media on bioethical issues.

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Who in the US Should Get the COVID-19 Vaccine First? - Medscape

Opinion | A Vaccine That Stops Covid-19 Wont Be Enough …

August 26, 2020

Focusing on how to block the coronaviruss transmission is a much more efficient approach.

This is why randomized controlled trials of the vaccines currently under consideration should include regular monitoring for the presence of SARS-CoV-2 in study subjects. The goal should be to evaluate whether the subjects acquire the infection at all, and for how long, as well as how abundantly they shed and spread the virus, when and how.

Studying these issues could also help cast a light on the role of so-called superspreading events in this pandemic.

More and more research suggests that a very small number of instances gatherings at restaurants or bars, choir rehearsal, funerals, church services might account for a vast majority of the cases of infection overall.

But the discussion about those instances has tended to focus on their settings and circumstances, such as the presence of crowds in confined spaces for extended periods of time.

Yet the question of whether some infected individuals, perhaps especially at certain stages of infection, are particularly infectious whether they, themselves, are superspreaders also needs to be studied head-on: When does contagiousness peak in whom and why? And can vaccines modify any of that?

The best vaccines dont just protect the inoculated from getting sick from a disease. They also protect everyone else from even contracting the pathogen that causes that disease.

Preventing the very transmission of SARS-CoV-2, no less than stopping it from turning into Covid-19, should be a main priority of current efforts to develop the vaccines to end this pandemic.

Adam Finn (@adamhfinn) is a senior clinician in the pediatric immunology and infectious diseases clinical service at Bristol Royal Hospital for Children and a professor of pediatrics at the University of Bristol. Richard Malley (@rickmalley) is a physician specializing in infectious diseases at Boston Childrens Hospital and a professor of pediatrics at Harvard Medical School.

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Opinion | A Vaccine That Stops Covid-19 Wont Be Enough ...

COVID-19 vaccine: From the lab to your doorstep – DW (English)

August 26, 2020

Long parallel aisles flanked by columns of nearly two-meter tall freezers, each set to -80 degrees Celsius (-112 Fahrenheit), is where some of the COVID-19 vaccines will be making a pit stop before arriving at your doorstep.

The huge facility the size of a soccer field is one of the two freezer farms that US logistics firm UPS is building to safely store millions of doses of coronavirus vaccines and promptly ship them across the world.

The farms are part of a global effort that has seen governments, international organizations, pharmaceutical companiesand logistics firms pump billions of dollars to kickstart mass production of yet-to-be approved vaccines and to boost supply chain capabilities, ensuring they are not caught off guard once the vaccines are given the green light.

"We are currently leveraging[our experience and expertise] and investing and gearing up to be able to support the pharmaceutical industry, support the battle against the COVID virus," Anouk Hesen, the head of UPS Healthcare in the Netherlands, told DW.

The facilities, being built close to UPS air cargo hubs in the United States and Germany, will together house 600 freezers, each capable of storing 48,000 vials of vaccine. The deep-freezers are being set up to store the more fragile vaccines, including those that are based on messenger RNA (mRNA) to produce viral proteins in the body.

Hesen did not disclose if the company had already scored any clients for the freezer farms, only saying it was in talks with "leading pharmaceutical companies" without disclosing any names. US company Moderna, Pfizer and BioNTech, a German biotech firm, and Curevac, another German firm, are some of the leading names working on vaccines based on mRNA.

The deep freezers at the facilities will be set to -80 degrees Celsius.

Once ready, vaccines will leave the laboratory in specialized, well-insulated boxes, filled with dry ice or frozen carbon dioxide. The boxes will be brought to one of the freezer farms, where they would be carefully opened on a soft stretcherlike table and stored in freezers.

"You would not be able to operate in the freezer farms without personal protective equipment [PPE]. So, our people are supplied with the right gear, like specific gloves and goggles to be able to handle the products inside," Hesen told DW. "It's not a temperature that you'll be able to walk into."

Based on instructions or orders from customers, the vaccines would be put back in insulated boxes filled with dry ice, capable of maintaining an ideal temperature for up to 96 hours. Depending on how stringent specifications willbe, the repackaging will take place in a room with temperature as low as -20 degrees Celsius or one with temperatures ranging from 2 degrees to 8 degrees Celsius the ideal storage temperature range for most vaccines to ensure the shots are not compromised.

The vaccines will then be shipped by air while ensuring they remain stable. UPS says it would be able to provide overnight delivery to almost any part of the world thanks to the proximity of its freezer farmsin Louisville, in the US state of Kentucky, and the Venlo-Roermond area in the Netherlands, to its air hubs. The firm is also setting up deep-freeze units in some places, including in Frankfurt and the UK.

With COVID-19 vaccines being developed at an unprecedented pace, there is hardly any data available on their fragility or stability. UPS is in talks with vaccine makers and US authorities, including the Operation Warp Speed team a public-private partnership initiated by the Trump administration to accelerate vaccine development about how the supply chain would look like. Some experts say the first shipments of the shots would need to be transported at "vaccine-untypical"conditions of -20 degrees Celsius, if not at -80 degrees a major challenge for freight companies.

UPS is also boosting capacity to store vaccines that can remain stable in 2-8 degrees Celsius

UPS is gaining critical hands-on experience; one of its units is involved in delivering COVID-19 vaccines for clinical trials under strict guidelines. Thefirm, based in the US city of Atlanta, Georgia, was also part of global efforts to distribute huge volumes of PPE kits for health care workers, coronavirus test kits and equipment for intensive care units at the height of the pandemic.

There are close to 170 vaccines in development, with 30 of them in clinical trials, according to the World Health Organization. Not all vaccines under development wouldneed to be stored at -80 degrees Celsius; the less fragile ones would be able to maintain potency at higher temperatures.

UPS is adding storage space even for these vaccines as can be noticed from rows of empty yellow shelves in a hall with the temperature ranging from 2-8 degrees at its Roermond facility.

Hesen did not reveal how much UPS is investing in its COVID-19 efforts but said the freezer farms are part of the company's plans to expand its health care offerings and that it expects them to remain in demand even after the pandemic ends.

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COVID-19 vaccine: From the lab to your doorstep - DW (English)

Could U.S. regulators authorize a COVID-19 vaccine before the election? – Reuters

August 26, 2020

NEW YORK/CHICAGO (Reuters) - U.S. President Donald Trump has said a vaccine for the novel coronavirus could be available before the Nov. 3 presidential election, sooner than most experts anticipate.

FILE PHOTO: A small bottle labeled with a "Vaccine" sticker is held near a medical syringe in front of displayed "Coronavirus COVID-19" words in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/Illustration

A COVID-19 vaccine as early as October could become a reality if drugmakers deliver on optimistic timelines for completing large, late-stage clinical trials and regulators allow for its use prior to a full review and approval.

HOW CAN U.S. REGULATORS SPEED UP AVAILABILITY OF A VACCINE?

The U.S. Food and Drug Administration can greenlight medical products during public health emergencies by issuing an emergency use authorization (EUA) before all the data are in to complete a formal review.

The FDA has issued EUAs for many COVID-19 tests and for a few treatments. On Sunday, the FDA authorized on an emergency basis the use blood plasma from recovered COVID-19 patients as a treatment. The FDA commissioner later corrected data he cited at a news conference that significantly overstated the treatments known ability to save lives.

EUAs are not typically used for vaccines intended for healthy people to prevent infection. That presents a higher bar for approval than treatments for people with life-threatening disease.

Nevertheless, the FDA in June released EUA guidance for COVID-19 vaccines. Once it grants an EUA, the agency eventually must issue a formal marketing approval or revoke emergency authorization.

Typical FDA approval reviews take eight months or longer, with a priority review shaving off a couple of months. But the agency has moved quickly during past public health crises. During the 2009 H1N1 swine flu pandemic, it only took two months to get an approved vaccine, but those were based on existing seasonal flu vaccines.

An EUA for a vaccine using a new approach might only save a few weeks, some experts say. The FDA would still need substantial data, said Dr. Kathryn Edwards, former chairwoman of the FDAs vaccine advisory committee and scientific director at the Vanderbilt Vaccine Research Program.

What they do seem to be telling us is that once you show that your vaccine works ... that might be a time when an EUA may be used before the paperwork is completed, said Filip Dubovsky, chief medical officer of vaccine maker Novavax Inc (NVAX.O).

The U.S. government decided against an EUA for the H1N1 vaccine after a survey found 64% of Americans would not take it if it had not gone through the formal approval process.

Consumer rights watchdog Public Citizen urged regulators not to use an EUA for COVID-19 vaccines, which it says could create the appearance of a rushed review.

The FDA and other U.S. health experts say there must be sufficient safety and efficacy data before a vaccine is authorized for public use.

I certainly would not recommend nor would I ever allow myself to be injected with a vaccine that has not been thoroughly vetted and approved by the FDA, said former FDA associate commissioner Dr. Peter Pitts, president of the Center for Medicine in the Public Interest.

COULD TRUMP PRESSURE THE FDA TO ISSUE AN EUA WITHOUT SUFFICIENT DATA?

Trump, without citing evidence, on Saturday accused deep state elements in the FDA of holding up vaccines and treatments in order to undermine his reelection prospects.

FDA Commissioner Stephan Hahn has denied that assertion. Peter Marks, one of the FDAs top drug reviewers, told Reuters he would resign if he felt the agency was pressured to approve a vaccine before it was ready.

Dr. Jesse Goodman of Georgetown University, a former FDA chief scientist, said a vaccine EUA could undermine public confidence in the agency. He cited pressure around hydroxychloroquine, a treatment pushed by Trump and others in his administration, which received an EUA that was later revoked when data showed a lack of efficacy and safety issues.

Were certainly seeing a situation where norms are not being respected government-wide, Goodman said.

WHICH DRUGMAKERS HAVE A SHOT AT A VIABLE VACCINE BEFORE THE ELECTION?

AstraZeneca Plc (AZN.L) in conjunction with Oxford University researchers and Pfizer Inc (PFE.N) with partner BioNTech SE (22UAy.F) have said they could have pivotal data by October. Moderna Inc (MRNA.O) is not far behind with late-stage data expected as soon as November or December.

Reporting by Carl O'Donnell and Julie Steenhuysen, editing by Peter Henderson and Bill Berkrot

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Could U.S. regulators authorize a COVID-19 vaccine before the election? - Reuters

Will Trump Pressure the FDA to Approve a Covid-19 Vaccine …

August 26, 2020

On Saturday, President Donald Trump fired off one of his most deranged, conspiratorial, and flat-out terrifying tweets since he took office which at this point is really saying something.

The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics, he wrote. Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!

In other words, Trump is claiming there are anti-Trump forces in the Food and Drug Administration who are deliberately hamstringing efforts to develop a Covid-19 vaccine in order to hurt his re-election chances. Trump wrote that this is obviously the case, tagging FDA Commissioner Stephen Hahn, whom Rolling Stone dubbed one of the four men responsible for Americas failed response to the pandemic, along with Trump.

Trumps tweet came five days after his trade adviser, Peter Navarro, reportedly accused FDA officials to their faces of being part of the Deep State, telling them they need to get on Trump Time in facilitating a cure for the novel, once-in-a-generation virus that has now killed over 175,000 Americans. The blame has to fall somewhere, and of course it cant be on the Trump administration, which has an election to win.

Trump and Navarros frustration stems from both the lack of a vaccine which typically take years, not months, to develop and the lack of approved therapeutics to treat the virus. After the FDA last week put a hold on granting emergency-use authorization for using blood plasma from people who have recovered from Covid-19 to treat the virus, Trump told reporters it could be a political decision. After alleging on Saturday that the agency is run by the Deep State, Trump criticized its decision in June to revoke the emergency-use authorization for hydroxychloroquine, a drug Trump and Navarro championed and which the FDA ultimately deemed an ineffective Covid-19 therapeutic.

As fate would have it, a day after Trumps critical tweets the FDA issued an emergency-use authorization for using blood plasma to treat Covid-19. The decision was made despite objections from government scientists at the National Institute of Health, including Dr. Anthony Fauci, who argued that the data on plasmas effectiveness was insufficient. The pressure from the Trump administration apparently carried a little more weight. We broke the logjam over the last week, Trump said during a press briefing on Sunday. I think there are people in the FDA and actually in your larger department that can see things being held up.

The potential for the FDA to cow to pressure from Trump has been a concern since the race to develop a vaccine began. The concern is swelling now that the president is trailing in the 2020 election polls and desperate for a win such as, say, headlines about a vaccine breakthrough. Unfortunately, Trump Time, as Navarro puts it, has no real concern for the opinion of scientists, or for the fact that it typically takes years if not decades to develop a safe and effective vaccine. Rushing the approval of a Covid-19 inoculation, or therapeutics, that could be administered to tens of millions could lead to a public-health catastrophe on top of the existing public-health catastrophe.

Although we see regulation as burdensome, you want the FDA to regulate these products, Dr. Paul Offit, director of the Vaccine Education Center at the Childrens Hospital of Philadelphia and a member of the FDAs vaccine advisory committee, told Rolling Stone in May. You want someone to take a long hard look at what the data are before they license it for use in this country.

There was a moment when Donald Trump said the FDA was working with them, Offit said. That worries me.

Others took comfort in the integrity of the scientists staffed at the Food and Drug Administration. FDA employees tend to insulate themselves pretty well from all the hype, and they tend to look at things without bias, Dr. Peter Hotez, dean of Baylors College of Tropical Medicine, told Rolling Stone. Theyre really good scientists trying to think through this, so I dont think theyre going to be swayed. But who knows whats going to happen.

What could happen, though, is that the good scientists will just resign. On Friday, Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, told Reuters he would step down if the Trump administration forces the approval of a vaccine that has yet to be proven safe and effective. I could not stand by and see something that was unsafe or ineffective that was being put through, he said. You have to decide where your red line is, and thats my red line. I would feel obligated [to resign] because in doing so, I would indicate to the American public that theres something wrong.

Marks initially threatened to resign during a recent call between government officials, pharmaceutical executives, and members of the NIHs working group on vaccines. Concern was reportedly expressed about an October surprise in which the Trump administration would rush to announce a vaccine candidate right before the election, prompting Marks to say hed step down if this happened.

Although Trump has said on multiple occasions that a vaccine could be ready by the election, this is unlikely, if not impossible. Hotez told Rolling Stone that late 2021 or early 2022 is the best-case scenario. Its not going to be easy, he said. Its going to have to be a very carefully orchestrated dance between the epidemiological models, the scientists, the business community, and government leaders to work this out. Its doable, but its not going to be easy.

The president might not see that timeline working for him.

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Will Trump Pressure the FDA to Approve a Covid-19 Vaccine ...

Legislature needs an emergency hearing on vaccines for COVID-19 and the flu – CALmatters

August 26, 2020

In summary

Its critical that we encourage the early adoption of any successfully developed COVID-19 vaccine and promote the widespread use of the flu vaccine.

Kelly Danielpour is a high school senior at Crossroads School in Santa Monica, VaxTeen@gmail.com. Shes the founder of VaxTeen and works as an intern for Dr. Jeffrey Klausner, researching Californias vaccine policy.

Dr. Jeffrey Klausner is a professor of Medicine and Public Health at the University of California, Los Angeles. He is a former medical officer for the Centers for Disease Prevention and Control, and a former deputy health officer at the San Francisco Department of Public Health, JDKlausner@mednet.ucla.edu.

As we attempt to mitigate the widespread effects of the COVID-19 pandemic, our legislators must address several urgent issues.

Its critical that we encourage the early adoption of any successfully developed COVID-19 vaccine. We must promote the widespread use of the vaccines we already have in particular, the flu vaccine, before this years flu season begins. And we need to curb growing vaccine hesitancy while putting systems in place to facilitate and manage the use of vaccines.

Keep tabs on the latest California policy and politics news

The convergence of this falls flu season with a second wave of COVID-19 infections could be disastrous. Since influenza and COVID-19 have similar symptoms, people will likely misattribute them and clog health care systems. Patients will need to be tested for both viruses, placing a strain on personnel and supplies.

If the flu season is severe with a high rate of hospitalization, combined with COVID-19, this could quickly overburden hospitals. Although the flu vaccine does not provide 100% protection, it reduces symptoms and the likelihood of hospitalization. We need to vaccinate all eligible Californians against the flu now.

During the coronavirus pandemic, childhood vaccination rates have fallen dramatically in California, nationally and globally, fueling concerns of outbreaks of vaccine-preventable diseases.

This April, vaccine doses given to California children fell by more than 40% compared to the previous year. Parents have avoided doctors offices, fearing COVID-19 exposure, but the risk is low with the numerous precautions in place. We could soon be facing outbreaks of measles and chickenpox alongside COVID-19.

This backlog of missed vaccinations only heightens the urgency of improving Californias immunization registries. These databases keep track of vaccinations and will play a key part in children catching up on vaccinations, as well as the uptake of an eventual COVID-19 vaccine.

In California, many providers are required to input all vaccination information, but there are large gaps in reporting, and registries arent sufficiently accessible to parents and those who have been vaccinated. Exacerbating the concern, vaccines against COVID-19 will likely require two doses given about a month apart and come in several types.

Without a thorough centralized system keeping track of who got what vaccine and when, vaccine distribution will become chaotic. Improved registries would also allow us to identify and target areas where vaccination compliance is lacking. To navigate COVID-19s impacts, Californias immunization registries require legislators immediate attention.

Further compounding the unnecessary toll of preventable illnesses in California are the low rates of human papillomavirus vaccination, which continue to result in increased cancer cases and significant costs to the state. A recent UCLA study suggested that if 99.5% of Californias population were fully vaccinated against HPV, approximately 74% of HPV-related cancer cases and the huge associated economic burdens on the health care system would be averted. Its time for the state Legislature to require HPV vaccination for all young Californians as a condition of school entry.

All of these concerns are tied to the overarching problem of growing vaccine hesitancy, something that threatens all Californians health. This has been furthered by the widespread distribution of vaccine misinformation, which has been allowed to grow and fester unchecked.

In addition to witnessing outbreaks of once-eliminated diseases due to under-vaccinated communities, were facing the alarming prospect that a significant portion of the population would refuse a COVID-19 vaccination. Theres a high likelihood that this would prevent us from attaining the level of herd immunity necessary to stem transmission and allow the diseases devastating toll to continue to mount.

We urgently need new legislation that would support science-based community education to counteract the pernicious effects of the anti-vaccine movement and research to identify sources of vaccine hesitancy.

Our state leaders need to act decisively to protect the health of all Californians. As the current pandemic has shown us, vaccinations are crucial both in saving lives and averting economic catastrophe. With the flu season fast approaching, along with a possible second wave of COVID-19 infections, and hopefully a COVID-19 vaccine, theres no time to waste. Legislators need to convene an emergency hearing on vaccines and methods of assuring their equitable use now.

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Dr. Jeffrey Klausner has also written about ending the state of emergency over COVID-19, Californias shelter-at-home-policy and the sexually transmitted disease crisis.

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Legislature needs an emergency hearing on vaccines for COVID-19 and the flu - CALmatters

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