Alex Azar says there’ll be enough Covid vaccine for all Americans by March

Health and human services secretary Alex Azar says there will be enough doses of COVID-19 vaccine for ‘all Americans’ by March after Pfizer revealed its jab may be 90 percent effective. 

Azar gave a timeline on Tuesday for when the coronavirus vaccine would be rolled out after Pfizer said a day earlier it was on track to apply later this month for emergency-use approval from the FDA. 

He said the US could receive 20 million doses per month starting at the end of this month if Pfizer moves as quickly as expected to secure regulatory approval.   

‘We have anticipated that we will have enough vaccine by the end of December to have vaccinated our most vulnerable citizens in nursing homes and otherwise,’ Azar told NBC’s Today.

‘By January, enough for all health care workers and first responders and enough for all Americans by the end of March to early April to have general vaccination programs.’

While news of the potential breakthrough in a COVID-19 vaccine has fueled hope, the government now faces logistical challenges, including how to effectively distribute the jab on a wide scale level and the financial burden that will bring for states. 

The Trump administration has paid $1.95 billion for 100 million initial doses of the Pfizer vaccine. Pfizer says it could have up to 50 million doses available by the end of this year if approved. 

Manufacturers already have begun stockpiling vaccine doses in anticipation of eventual approval but the first shots will be in short supply and rationed. 

State health officials have already estimated they will need additional funds to help distribute the vaccine.

The CDC announced $200 million in funding back in September to specifically help states with vaccine planning but state officials have already said that isn’t enough.

Pfizer’s vaccine also needs to be stored in ultra-cold temperatures that some experts have said match an Antarctic winter.

The CDC asked states last month to identify locations that could store a vaccine in temperatures of 94 degrees Fahrenheit below zero.

Pfizer has already said it plans to personally handle the physical distribution of its vaccine by shipping to those locations.  

It will not use the government’s main distribution partner, McKesson, on shipping the vaccine. 

Pfizer has previously said it will fit its shipments with GPS trackers to stop any potential theft of its vaccines.  

State officials started submitting plans to the federal government last month on how they plan to distribute the vaccine.

Virginia was one of the few states that estimated how much it would cost the state to roll out distribution, according to Bloomberg.

The state says it will cost $120 million, including: $2.5 million for freezers and transportation equipment and $71 million to help local health departments set up clinics. 

The timing of Pfizer’s announcement, which came 48 hours after Joe Biden claimed victory and less than a week after the election, quickly raised questions. 

Trump has since accused the FDA of holding up Pfizer’s vaccine until after the election and said the decision to delay it would cost lives. 

‘As I have long said, @Pfizer and the others would only announce a vaccine after the election, because they didn’t have the courage to do it before. Likewise, the @US_FDA should have announced it earlier, not for political purposes, but for saving lives!’ Trump tweeted on Monday night. 

‘The @US_FDA and the Democrats didn’t want to have me get a Vaccine WIN, prior to the election, so instead it came out five days later – As I’ve said all along!’

President-elect Joe Biden welcomed Pfizer’s news but cautioned that it could be many months before vaccinations become widespread in the US. He warned Americans to rely on masks and social distancing in the meantime, saying the country still faces a ‘dark winter’.  

The timing of Pfizer’s announcement, which came 48 hours after Joe Biden claimed victory and less than a week after the election, quickly raised questions. Trump has since accused the FDA of holding up Pfizer’s vaccine until after the election and said the decision to delay it would cost lives

Trump’s son, Don Jr., immediately raised questions about the timing of Pfizer’s announcement, tweeting on Monday: ‘The timing of this is pretty amazing. Nothing nefarious about the timing of this at all right?’

Pfizer, which developed its vaccine with German drugmaker BioNTech, became the first to release promising preliminary findings of its jab based on early and incomplete test results.

With a possible 90 percent efficacy rate, Pfizer is on track to apply later this month for emergency-use approval from the FDA once it has the necessary safety information in hand. 

Authorities have stressed, however, that it is unlikely any vaccine will arrive much before the end of the year and the limited initial supplies will be rationed. 

The drugmaker had initially said it would know if its vaccine was effective by October but shifted that timeline last month to say it expects to seek FDA authorization in the third week of November. 

Pfizer is still on track to meet that timeline. 

The company said the results of its preliminary analysis came after a discussion with the FDA but it is not yet clear exactly what those discussions involved or when they occurred. 

Nearly 44,000 people are enrolled in Pfizer’s final testing of the vaccine. Pfizer has said that 94 people in the trial have so far tested positive for COVID-19. 

Over 90 percent effectiveness implies that no more than eight of the 94 people who caught COVID-19 had been given the vaccine. 

Doing the math, that would mean almost all the infections counted so far had to have occurred in people who got the dummy shots.  

The efficacy rate is well above the 50 percent effectiveness required by the FDA for a vaccine. To confirm the efficacy rate, Pfizer said it will continue the trial until there are 164 COVID-19 cases among participants.  

The Trump administration has paid $1.95 billion for 100 million initial doses of the Pfizer vaccine. Pfizer says it could have up to 50 million doses available by the end of this year if approved

The FDA has also said companies must track half their participants for side effects for at least two months, which Pfizer says it expects to reach later this month.

Pfizer’s initial plans called for evaluating the vaccine when just 32 infections had been counted. Many scientists, however, warned that was simply too small to draw conclusions about a vaccine needed by billions.

Pfizer said it reconsidered and went back to the FDA for permission to change the plan and do its first interim analysis when there were more cases. 

By the time Pfizer made the change and caught up with a backlog of virus tests, the board had 94 infections to analyze.

Meanwhile, the FDA on Monday allowed emergency use of the first antibody drug to help the immune system fight COVID-19.

The FDA cleared the experimental drug from Eli Lilly for people 12 and older with mild or moderate COVID-19 not requiring hospitalization. 

It’s a one-time treatment given through an IV.

The therapy is still undergoing additional testing to establish its safety and effectiveness. 

It is similar to a treatment Trump received after contracting the virus last month. 

Early results suggest the drug, called bamlanivimab, may help clear the coronavirus sooner and possibly cut hospitalizations in people with mild to moderate COVID-19. 

A study of it in hospitalized patients was stopped when independent monitors saw the drug did not seem to be helping in that situation.

The government previously reached an agreement to buy and supply much of the early production of Lilly’s drug.

Only one drug – Gilead Science’ remdesivir – has full FDA approval for treating COVID-19. 

Government treatment guidelines also back using dexamethasone and other steroids for certain severely ill, hospitalized patients. 

FDA regulators authorized the Lilly drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.

In normal times the FDA requires ‘substantial evidence’ to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment´s potential benefits outweigh its risks.

The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Lilly will have to submit additional research to fully define the drug´s safety and benefit for patients.

The government has signed an agreement with Lilly to spend $375 million to buy 300,000 vials of the drug. How many doses that would provide is unclear. Each vial contains 700 milligrams and that dose proved ineffective in the early results. It took four times that amount – 2,800 milligrams – to show any effect.  

Source: | This article originally belongs to Dailymail.co.uk

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