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UK Approves Updated Covid-19 Vaccine From Moderna, Targets Omicron And Original Strain 

The United Kingdom has become the first nation to approve an updated version of Moderna’s Covid-19 vaccine booster, meant to target the omicron strain as well as the original virus that first appeared in 2020. 

“An updated version of the COVID-19 vaccine made by Moderna that targets two coronavirus variants (known as a “bivalent” vaccine) has today been approved for adult booster doses by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness,” read an official government release.

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“Half of the booster, called Spikevax bivalent Original/Omicron, targets the original coronavirus strain while the other half targets Omicron,” it said.

The MHRA, the UK government’s independent expert scientific advisory board, endorsed the decision to approve of the new vaccine after carefully reviewing the evidence. 

The clinical trial by Moderna reported that the booster targets Omicron and showed a stronger immune response against the variant in addition to the original strain. The company said the “updated booster showed a potent response against BA.4 and BA. 5 sub variants.” 

“The side effects are the same as for the original Moderna booster dose and found to be typically mild and self-resolving. No serious safety concerns were identified,” the UK government release said.

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MHRA Chief Executive Dr. June Raine said that “the new Moderna booster will help keep communities protected.

“The first generation of COVID-19 vaccines being used in the UK continue to provide important protection against the disease and save lives. What this bivalent vaccine gives us is a sharpened tool in our armory to help protect us against this disease as the virus continues to evolve.”

The UK’s Joint Committee on Vaccination and Immunization will advise on the vaccine’s rollout, as it is not yet clear who will be offered the booster or when. 

Stéphane Bancel, Chief Executive Officer of Moderna, said on Twitter he was “delighted the vaccine had been approved.”

“This represents the first authorization of an Omicron-containing bivalent vaccine, this bivalent vaccine has an important role to play in protecting people in the UK from Covid-19 as we enter the winter months.”

Besides Moderna, Pfizer and BioNTech have been testing two Covid-19 vaccine boosters that will also target the Omicron variant.

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Following Unanimous Vote, CDC Recommends Novavax COVID-19 Vaccine

On Tuesday, a panel of the Center for Disease Control and Prevention’s (CDC) outside vaccine advisors voted to recommend the use of the Novavax COVID-19 vaccination for those 18 and older.

“Novavax’s COVID-19 vaccine, which will be available in the coming weeks, is an important tool in the pandemic and provides a more familiar type of COVID-19 vaccine technology for adults,” the CDC said in a statement.

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Novavax’s vaccine had previously been authorized by U.S. regulators last week, but the CDC’s approval was the final obstacle for it to become available. The agency stressed the importance of multiple options and flexibility for the public.

67.6% of the American population is fully vaccinated, with 79.1% having received at least one dose. However, the CDC stated there are still between 26 million to 37 million adults who have yet to receive a single dosage.

“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” CDC Director Dr. Rochelle Walensky said.

“With COVID-19 cases on the rise again across parts of the country, vaccination is critical to help protect against the complications of severe COVID-19 disease.” 

The Novavax vaccine is particularly interesting because of how it works in contrast to other COVID-19 vaccines. All vaccines are trained to recognize the virus’ outer coating, the spike protein. Vaccines like Moderna and Pzifer give the body genetic instructions on how to replicate the spike protein.

In contrast, instead of telling the body how to make spike protein copies, the Novavax vaccine delivers copies, made in a lab and packaged into nanoparticles, straight to the body that will help the immune system to respond to the vaccine.

One of the ingredients used in this process is adjuvant. The CDC noted vaccines using protein subunits “have been used for more than 30 years in the United States, beginning with the first licensed hepatitis B vaccine” and later with influenza and whooping cough.

According to a Food and Drug Administration (FDA) report, the vaccine was found to be 90% effective against mild, moderate, and severe disease in Novavax’s Phase 3 trial, which involved 30,000 participants.

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While that study was done before the Delta and Omicron waves, leaving the vaccine’s efficiency against the subvariants unknown, the company also possesses a COVID-19 Omicron vaccine that currently sits in Phase 3.

The hope is that the Novavax vaccine will present familiarity and assurance to those who haven’t received a dosage due to the mRNA technology utilized being unfamiliar.

It’s anyone’s guess as to if that play will work, but more vaccinations of any kind will undoubtedly help to continue curbing a pandemic that’s once again seeing surges in the warm summer months. The country is currently averaging 127,000 new cases per day.

The Novavax vaccine’s initial quantity will be scarce, the Biden Administration told states, which will be unable to start requesting shipments until next week. Additionally, not all providers will carry the vaccine. Given the timeline presented, the Novavax vaccine should start seeing use sometime in August.

Child Vaccine

FDA Says Pfizer-BioNTech Covid-19 Vaccine Safe And Effective For Children Under 5

Staff for the US Food and Drug Administration (FDA), said on Sunday that the Covid-19 vaccine made by Pfizer and BioNTech is safe and effective for children under the age of 5. Staff members said the vaccine is effective in producing a virus-blocking response without any major safety concerns, now the results will be studied by a group of independent advisers for the FDA.

Independent experts working for the agency will review a request for emergency use authorization for the vaccine in children under the age of 5. The group will also review a similar request from Moderna for the use of their vaccine for children under the age of 6. 

After the advisers make their recommendations, the FDA will then decide whether or not to follow the panel’s advice, which it likely will. If the agency approves, and the Centers for Disease Control and Prevention (CDC) do the same, the vaccines could be available for young children and infants as soon as the beginning of next week. 

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According to the FDA, “overall preliminary data indicated the vaccine was 80.4% effective in preventing symptomatic covid-19. The rate was 75.6% for babies and toddlers six to 23 months old, and 82.4% for children 2-to-4-years-old.

It’s still too soon, however, to reach definitive conclusions on the vaccine’s effectiveness.”

“Side effects were minimal and included irritability and drowsiness for children 6-to-23-months-old, and pain at the injection site and fatigue for children 2 to 4. Babies and children younger than 5 — a group numbering 19 million — remain the only age group in the United States not yet eligible for a coronavirus vaccine.”

The FDA also emphasized with these findings that they believe vaccines for the youngest group of Americans are critical for navigating the rest of the pandemic. 

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“Given the uncertainty of the pandemic and likely continued virus transmission in coming months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” the agency said.

Assuming that both Pfizer and Moderna receive an emergency use authorization, most children will likely be able to receive their shots at their pediatricians office, however, many states and communities are already gearing up to set up vaccine clinics and make the shots available throughout local pharmacies. 

Sallie Permar, an expert in pediatric vaccines, said that her facility will offer both vaccine options to ideally make it easier for the parents to choose what they want their child to receive. 

“While there may be some confusion over the difference between the two vaccines, offering both gives you more flexibility. Parents can weigh all the information and decide,” she explained. 

U.S. Opens Second COVID-19 Boosters For Americans 50 And Up

On Tuesday, the Food and Drug Administration (FDA) authorized an extra dosage of the Pfizer or Moderna vaccine for Americans 50 and up — plus certain younger age groups that are higher risk for COVID-19 — given that it’s been four months their last vaccination.

The Center for Disease Control and Prevention (CDC)’s director Dr. Rochelle Walensky discussed the additional booster, stating how anyone who was boosted during the recent Omicron surge — which saw a peak of over 1.1 million new cases in a single day in January — was much less likely to either be hospitalized or die.

“During the recent Omicron surge, those who were boosted were 21-times less likely to die from COVID-19 compared to those who were unvaccinated, and 7-times less likely to be hospitalized.”

Walensky added that the new dosage is “especially important” for those 65 and up. Still, while the Center has assured the second booster will give extra protection to those more susceptible to the virus, it didn’t go so far as to say the new shot is a necessary precaution that should be taken as soon as possible.

The FDA’s vaccine chief Dr. Peter Marks explained that regulators set the age at 50 because that’s when chronic conditions that increase COVID-19 risks begin to appear. People between the ages of 50 to 64 have accounted for around 18% (182,663) of all COVID-19 related deaths since 2020.

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Prior to this authorization, the FDA only allowed a fourth dosage for immune-compromised as young as 12. Those who have already received a fourth shot will also be eligible for a fifth, though it has to be a Pfizer shot for those ages 12 to 17. Only adults 18 and older can receive a Moderna or Johnson & Johnson vaccination.

Meanwhile, anyone who received J&J’s vaccination — which only requires one initial dosage instead of two — and a booster can receive either a Pfizer or Modern shot, which are preferred in most situations by the CDC. While a J&J user can get their first booster only two months after the vaccination (instead of the standard five), they must wait four months for their third like their two counterparts.

Currently, 77.5% (255 million) of the U.S. population has received at least one vaccination dosage, while 66% (217 million) are fully vaccinated. 29.6% (97 million) have received a booster through the first seven months of it being administered.

The second booster comes at an uncertain and critical time in a pandemic that’s now entering its 25th month. Hope certainly abounds: cases in the U.S. are significantly down after the Omicron surgance, with Mar. 29 seeing just 25,628 new cases (29,351 seven-day average), while daily cases haven’t reached over 100,000 in over a month.

Still, time may play a factor in where trends go from here. Original vaccinations are becoming less and less effective against new variants — which continue to pop up and threaten another spike — giving boosters that much more value.

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Most concerning is the Omicron “stealth” subvariant BA.2, which the CDC said is now dominant in the U.S. after it accounted for 55% of COVID-19 cases that have undergone genetic sequencing. The subvariant made up just 1% of sequenced cases back in early February.

White House chief medical advisor Dr. Anthony Fauci previously said that though Americans could see an uptick in cases due to BA.2, he doesn’t expect another surge. Other countries haven’t been so fortunate, with BA.2 causing outbreaks in the U.K. (which saw daily counts double in the last two weeks, along with a 11.5% rise in hospitalizations over the last seven days), Germany, and China.

Another potential issue is the funding behind the fourth dosage, should it become necessary, with the federal government having run out of money to pay for the testing and treatment of uninsured Americans. Moderna previously applied for a second booster for the general population earlier this month, though it did so to provide the CDC “flexibility” when recommending what groups should be eligible.

White House Discussing Covid-19 Booster Shot Plan Amid New CDC Data

Top Biden administration health officials have decided that most Americans will need Covid-19 booster shots after reviewing a new set of data from the US Centers for Disease Control and Prevention (CDC). The data showed a drop in vaccine efficacy over time after several months of observation and collection. 

Federal scientists who performed the research claim that a resurgence in Covid-19 cases has been caused by the spreading of the more contagious Delta variant, as well as a lack of individuals choosing to get vaccinated. 

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The Biden administration is now expected to formally announce a strategy plan for rolling out booster shots as well as new health and safety procedures to get America’s infection rate back down. 

The government is not expected to offer third shots of the Pfizer or Moderna vaccines until mid-September at the very earliest. The Food and Drug Administration (FDA) must first authorize the booster shots, and it’s likely that the CDC will formally recommend that everyone gets one eight months after completing their initial vaccination round. 

As of right now the plan doesn’t call for boosters for recipients of the single-dose Johnson & Johnson vaccine, but federal officials are currently awaiting results of a study on that vaccine and the effectiveness of administering a second booster shot. 

Officials at the CDC have been skeptical within the past few months over whether or not booster shots would be necessary for vaccinated Americans. However, health officials all over the country working on the front lines in hospitals and ICU units have been calling for a more efficient vaccination plan or the implementation of another lockdown to slow the spread of Covid and its variants. 

Data from a study in Israel showed that Pfizer’s efficacy declined for older individuals who received their shots in January when they were first made available. The CDC had similar findings that provided them all they needed to make a recommendation for booster shots. 

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It’s expected that the administration’s emerging booster plan will rely on 100 million doses of both Pfizer and Moderna’s vaccines. The government has also contracted for an additional 400 million shots to be distributed once an official announcement is made, according to two senior officials working in the White House. 

The World Health Organization (WHO) has urged developed countries to hold off on all booster shots until more lower-income countries get access to their initial supplies of the vaccines. 

“Administration of booster doses will exacerbate inequalities by driving up demand and consuming scarce supply while priority populations in some countries, or subnational settings, have not yet received a primary vaccination series.”

Celine Gounder, an infectious disease specialist who also served on the Biden transition Covid-19 advisory board, is one of many health experts who also is against booster shots due to the fact that so many countries around the world are still vulnerable and unvaccinated.

“It’s really inequitable and it’s not in our interest because you’re leaving much of the world unprotected, where you’re going to have the emergence of other variants. I feel like this is very short-term thinking. It’s very individualistic, nationalist thinking.” 

A formal plan from the White House is likely to be released to the public this week regarding a booster shot plan and any new procedures America should implement to slow the spread of the virus.

Singapore Announces Separate Rules For People Who Received Their Covid-19 Vaccines 

Singapore is introducing new health and safety measures for those who are vaccinated against Covid-19. New cases are continuing to rise in the city, so only fully vaccinated individuals and people who have recovered from Covid-19 will now be able to dine in groups of five without taking a Covid test.

The health ministry made the announcement this week, stating these rules would go into effect on July 19th. Any food and beverage establishment must implement a system so that they can check every patrons vaccination status. 

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Children under the age of 12, who are not yet eligible for the vaccine, are able to dine together with members of their household without taking a Covid test. The press release from the health ministry claimed that individuals are fully vaccinated once it’s been two weeks since their second dose of either the Pfizer or Moderna vaccine. 

Authorities have also stated that those who receive shots developed by China’s Sinovac Biotech will not be given the same perfs as those who have received a Pfizer or Moderna vaccine. Sinovac’s vaccine has not yet been included in Singapore’s national vaccine program, and is only available in the city-state through a special access route. 

A cluster of about 120 new Covid cases have been linked to a KTV lounge in Singapore. Nightclubs, bars, KTV/karaoke lounges have all been banned from operating in Singapore since the beginning of the pandemic. 

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A number of these establishments have been able to remain open, however, by just serving beverages and food and not providing any other entertainment services. The number of new infections hit 127 this week; up 23 from the week before according to the health ministry. 

Singapore in total has experienced about 63,000 cases of Covid-19. Health Minister Ong Ye King recently told reporters that 73% of the population has received at least one dose of their vaccine while 45% of the population is fully vaccinated. 

That figure is currently set to rise by 50% in the coming weeks based on currently scheduled vaccination appointments in the city-state. 

“Our  country is well on track to meet its target of having two-thirds of its population to be fully vaccinated by August 9.”

Unvaccinated parties can still go out to eat at certain establishments, however, they need to endure testing and contact-tracing efforts beforehand.

Experts Claim Americans ‘Don’t Realize How Lucky We Are’ In Terms Of Covid-19 Vaccines

About 53% of all Americans are currently inoculated with at least one dose of a Covid-19 vaccine while about 44% of the population is now fully vaccinated, according to data from the US Centers for Disease Control and Prevention (CDC).

“We have a long way to go as a globe. The United States — we don’t even realize how lucky we are here because we’ve had access to the vaccine early on. We basically have people turning the vaccine away. We think the whole world behaves that way, but that’s not the case,” Dr. Suzanne Judd, an epidemiologist at the University of Alabama at Birmingham School of Public Health, said.

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All adults in America are currently eligible to receive one of the three vaccine options approved in the country; Pfizer, Moderna, or Johnson & Johnson. However, many other countries around the world only have one vaccine option available for their large populations of unvaccinated individuals. 

“There are whole countries where only 1% of the population has had access to the vaccine. That means the coronavirus will continue to spread in those countries and will be problematic in those countries.”

“It means travel restrictions could happen. It means that it may impact Americans in terms of how they interact through work with people from those countries. It definitely will continue to impact us, so we have to be aware that it’s a good 18 months away before there’s enough vaccine to really stop the spread of the virus worldwide,” Judd explained.

The CDC revealed that at least 13 states have hit their goals of getting 70% of their residents partially vaccinated, which has led to many governors lifting restrictions and mask mandates. However, there is still a large group of Americans who are refusing to get the vaccine. 

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According to the Kaiser Family Foundation, “7% of those who are unvaccinated said they will only get the shot if they are required, while 13% are still definitely not getting a vaccine.”

“The problem, though, is that mutant variants of the virus are able to form as the virus circulates for longer. So even with at least 70% vaccinated, there is still a risk.”

“That 30% that winds up in another state, say that the state makes it to 70% and there are 30% unvaccinated. It poses a risk to that 30%. We really want to get to the 70% target in all states. That’s what will make this virus go away and not stay with us. If we don’t, we’re going to wind up battling outbreaks basically,” Judd said. 

Vaccines are showing that they’re effective against fighting the new strains, but not as strongly as it fights the regular virus. 

“The initial variants, we were looking at 90% effective and maybe it’s more like 70% with the Delta variant, but that’s great. Honestly, that’s a public health win. 70% is not something to throw away and say ‘that’s not good enough.’ That’s so much better than 10, 15, 20%. Again, if we can get people vaccinated, we don’t have to worry about the Delta variant,” Judd claimed.

“It’s not just the United States that’s in this fight. It’s really a global fight, a global struggle, a global effort.”

CDC To Hold Emergency Meeting Over Rare Heart Inflammation Side Effect In Covid Vaccines 

The Centers for Disease Control and Prevention (CDC) announced this week that they will be holding an emergency meeting on June 18th to discuss reports of heart inflammation following doses of both the Pfizer and Moderna Covid-19 vaccines. While the CDC claims that these reports have been rare, they’re still higher than initially expected, hence the meeting. 

The CDC has identified 226 cases that could meet the agency’s definition of myocarditis and pericarditis following the injections. A majority of those who experienced inflammation have recovered while 41 experienced ongoing symptoms, 15 are still currently hospitalized, and 3 are in the intensive care unit.

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“It’s a bit of an apples-to-oranges comparison because, again, these are preliminary reports. Not all these will turn out to be true myocarditis or pericarditis reports.”

Dr. Tom Shimabukuro, a CDC vaccine safety official, stated that so far their findings were mostly “consistent with reports of rare cases of heart inflammation that had been studied in Israel and reported from the US Department of Defense earlier this year.” 

A panel of independent advisers for the Food and Drug Administration (FDA0 will be meeting this upcoming Thursday to review the new details regarding myocarditis and pericarditis. The meeting will also serve to discuss how the FDA should approach giving an emergency use authorization for using these vaccines in younger children; the next phase of reaching herd immunity in America. 

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Pfizer already received an emergency use authorization for their vaccine in Americans 12 and up last month, and announced that they were already going through trials to make sure it’s safe for children as young as 6 months old. Moderna is also in the process of seeking a EUA for their vaccine in adolescents. 

Pfizer believes they can finish their children’s trials by the beginning of September, while FDA officials have warned that authorizing vaccines for younger age groups, especially babies and toddlers, could take longer due to how much their bodies are still developing. The FDA believes children will likely be able to receive their vaccines by mid to late fall at the earliest. 

“We recognize that some adverse reactions, for example myocarditis or pericarditis as discussed earlier today, may be too infrequent to detect in a safety database of typical size for pre-licensure clinical trials,” said Dr. Doran Fink, a top official in the FDA’s vaccine office.

“Risk-benefit considerations to determine whether to issue an emergency use authorization for use of a COVID-19 vaccine into healthy pediatric individuals will need to account for this information, and risk-benefit consideration will likely be different, not only compared to those for adults, but also they may be different for younger versus older pediatric groups,” Dr. Marion Gruber, director of the FDA’s vaccine office, said at the meeting.

Scientist Holding Moderna Vaccine

Moderna Says Their Covid-19 Vaccine Is Safe For Adolescents 

Moderna announced this Tuesday that their Covid-19 vaccine is safe and effective in adolescents. The company is basing the announcement after completing phase 2 of 3 of a trial of 3,732 children aged from 12 to 17 in the US. 

Blood tests showed that the vaccine produces an immune response that was equivalent to the findings in adults. 

The trial wasn’t designed to look at efficacy, but more so how safe it was for younger teens and adolescents to take it. Initial observations did show that none of the children who received the vaccine got sick with Covid-19 starting 14 days after their second dose. 

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“Four of the children who received the placebo tested positive for Covid-19, which is consistent with a vaccine efficacy of 100%, that figure could also change as more data is collected.”

The results also showed that the vaccine was 93% effective after one dose at preventing mild cases of Covid-19; meaning only one or two symptoms would appear in anyone who tests positive after being vaccinated. 

The company said “the vaccine was generally well tolerated and no significant safety concerns were identified. Side effects included headache, fatigue, muscle pain and chills after administration of the second dose. Pain at the injection site was also sometimes observed.”

Moderna is planning on submitting the results to the US Food and Drug Administration in early June along with a request for authorization to use the vaccine in adolescents. The data will also be submitted to a peer-reviewed publication, as every other vaccine has in America. 

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The Moderna vaccine was already authorized in the US for individuals 18 and older, and after Moderna requests an emergency use authorization from the FDA it’s likely that it will be approved for all Americans aged 12 and up. 

The FDA has already approved of the Pfizer vaccine to be given to adolescents aged between 12 and 15, previously it was only available for those 16 and older. The fact that both of these vaccines have already been used frequently in adults all across America, experts claim it makes sense that they’re both also effective in younger individuals. 

According to reports from CNN, “both Pfizer and Moderna are currently testing their vaccines in younger children, ages 6 months to 11 years. Because those age groups may require varying doses, the process will likely take a little longer.”

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases recently claimed that elementary aged children likely won’t be vaccinated until the end of the year, however, he’s confident that every American, regardless of age, will be eligible by 2022.

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Vaccine Providers Pledge 240 Million Covid-19 Vaccine Doses By The End Of March 

Johnson & Johnson has joined Pfizer and Moderna in their commitment to the US to provide a total of 240 million vaccine doses by the end of March. The drug companies told a House subcommittee this week that they expect to deliver this amount of doses after Johnson & Johnson pledged to add 20 million additional doses to Pfizer and Moderna’s 220 million dose pledge should the company receive emergency use authorization from the US Food and Drug Administration this week. 

Dr. Richard Nettles is J&J’s vice president of medical affairs who spoke with the lawmakers regarding the company’s pledge should they receive the EUA as expected. 

“If the emergency use authorization is received as expected this week, we hope to contribute to ending this pandemic as soon as possible.”

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Nettles claims that the company is prepared to ship out 4 million doses immediately upon authorization of the vaccine. Executives from each of the vaccine makers testified before the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations this past Tuesday. 

If AstraZeneca secures an FDA authorization as well it will become the fourth Covid-19 vaccine available in the US. Dr. Ruud Dobber, the executive vice president and president of AstraZeneca’s biopharmaceuticals business unit, said the company “will immediately release 30 million doses upon authorization of the vaccine and up to 50 million doses by the end of April.”

Pfizer initially planned to deliver up to 40 million doses of their vaccine by the end of 2020, however, they just reached that milestone last week. Moderna was close to reaching their goal of 20 million doses by the end of 2020 but fell short by just a week. Executives for the companies claimed that a lack of access to raw materials and manufacturing a product that has never been made before were the main issues in production. John Young, Pfizer’s chief business officer, recently spoke about this issue to the media. 

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“We did initially experience some problems with the initial ramp up of our vaccine. We particularly saw some rate-limiting steps for raw materials.” 

“We ultimately had never–when we were trying to make those estimates — manufactured at this scale, and so we had a lot to learn along the way. As we look back, could we have maybe started earlier in that process and lining up all of the critical raw materials sooner, would we have been able to get there a little bit faster instead of the first week of January, last week of December? It’s possible. Certainly hindsight, and that is 20-20 for us,” said Moderna’s president Dr. Stephen Hoge.

Moderna is currently seeking FDA approval for increasing the number of doses in each Covid-19 vaccine vial from 10 to 15. Hodge claims this would “accelerate delivery substantially and decrease the demand for some critical, high-demand raw materials. Obviously, any gains — for instance, filling more doses in a vial — we will take. We need to get more doses more quickly into peoples’ arms.”

Johnson & Johnson will be finding out if they receive an emergency use authorization this Friday.