Coronavirus Now: COVID-19 & Vaccine Updates for September 24

As of September 24, confirmed cases of COVID-19 now number more than 230 million around the world, including more than 684,000 U.S. deaths. You can see a breakdown of coronavirus cases throughout the world and within the U.S. on the map and chart above.

Below you’ll find updates on the latest news about the coronavirus.


September 24 News Updates

CDC Reveals Pfizer Booster Decision

The CDC has approved a Pfizer vaccine booster for people who are ages 65 and older, Reuters reported. Additional approvals were given for adults in high-risk working environments and adults with underlying conditions. Boosters will start being available immediately at a number of pharmacies and people will not be required to submit documentation to prove risk.

CDC Director Rochelle Walensky revealed the decision, which broke with an advisory recommendation that wanted approval only given for a narrower group. The panel was concerned about heart inflammation, a rare side effect in young men, and difficulties with rolling out a booster.

The CDC has updated its website to note:

CDC now recommends that people aged 65 years and older, residents in long-term care settings, and people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 Vaccine at least 6 months after completing their Pfizer-BioNTech primary series. Other groups may receive a booster shot based on their individual risk and benefit.

Specifically, the Pfizer booster is recommended for:

  • Ages 65 and older and had their second Pfizer shot at least six months ago
  • Residents in long-term care settings and had their second Pfizer shot at least six months ago
  • Ages 50-64 with underlying medical conditions and had their second Pfizer shot at least six months ago

You can receive a Pfizer booster shot if you weigh the risks and decide you want one and  fall in one of the following categories:

  • Ages 18-49 with underlying conditions and had their second Pfizer shot at least six months ago
  • Ages 18-64 and are at increased risk due to occupational or institutional settings and had their second Pfizer shot at least six months ago

Risk of Heart Inflammation Much Lower Than 1 in 1,000

A Canadian preprint study from the University of Ottawa Heart Institute incorrectly suggested that one in 1,000 were at risk of heart inflammation from Pfizer and Moderna, The Province reported. The authors requested the paper be retracted due to incorrect data that inflated post-vaccine myocarditis rates.

The study only looked at 32 people, and in extrapolating the risk, the wrong denominator was used, The Province reported. A research letter in JAMA looking at cases in the Pacific northwest found an incidence of closer to 1 in 100,000, while an Israel study found a risk of one to five cases per 100,000, while the risk of heart inflammation from COVID was 11 per 100,000.

J&J Vaccine Says Booster Increases Vaccine Protection

In a press release, Johnson & Johnson revealed that real-world evidence and a phase 3 study confirmed that the single-shot vaccine provides long-lasting immune memory, and a booster increases that protection.

The real-world study was conducted from March to late July, included 390,000 people, and found 79% effectiveness against infection and 81% effectiveness against hospitalization. The press release noted: “There was no evidence of reduced effectiveness over the study duration, including when the Delta variant became dominant in the U.S.”

A booster at two months provided 94% protection against symptomatic infection in the U.S., 100% against severe COVID starting at two weeks post-vaccination, and 75% protection against moderate COVID-19 globally. Meanwhile, a booster given at six months increased antibody levels nine-fold, increasing to 12-fold four weeks after the booster.

Novavax on Track to File for FDA Emergency Use

Novavax revealed that it’s on track to file for FDA emergency use sometime during the fourth quarter of this year, Reuters reported. The company said it will deliver two billion doses in 2022. Novavax has just filed for emergency use approval with WHO, FT reported.

COVID Antivirals Being Tested

At least three COVID antiviral pills are being tested in clinical trials, NBC News reported. Results should be expected as soon as this winter. One, molnupiravir, is by Merck and Ridgeback Biotherapeutics. One is by Pfizer (PF-07321332) and one is by Roche and Atea Pharmaceuticals (AT-527.)


Ongoing Vaccine Updates

GettyA  woman leaves Life Care Center of Kirkland on February 29, 2020, in Kirkland, Washington.

Pfizer Updates (mRNA vaccine)

Pfizer is one of the mRNA vaccines. Pfizer-BioNTech’s Comirnaty vaccine was the first to receive full FDA approval in the United States in August. Approval was given for people ages 16 and older, and it was granted eight months after the emergency use authorization. Pfizer is now going to seek approval for a booster shot for people over 16, USA Today reported in August.

Third Dose Updates

The FDA authorized allowing people who are immunocompromised to get a third dose of Pfizer or Moderna, the two mRNA vaccines approved for use in the United States. USA Today reported aroudn the same time that the U.S. Department of Health and Human Services said Americans who received either vaccine would need a booster eight months later.

Israel HMO Maccabi reported in August that the early results of a study indicated a third Pfizer booster is 86% effective in people over 60, Reuters reported. The study compared results of 149,144 people over 60 who got a third dose at least one week earlier to 675,630 who had two doses between January and February. In the booster group, 37 tested positive after their third dose. In the control group, 1,064 tested positive. The severity of the 37 people was not disclosed.

A later Israeli study of the Pfizer vaccine found that a third dose can reduce the risk of infection significantly by 48 to 68% within 7 to 13 days, Smithsonian Magazine reported in September. Within 14 to 20 days that risk dropped by 70 to 84%. The duration of protection still isn’t known for the third dose.

Efficacy Against Earlier Strains

The first dose of the two-dose Pfizer/BioNTech vaccine delivered about 90% protection after 21 days against earlier strains, The Guardian reported in February. A real-world study in Israel of the Pfizer-BioNTech vaccine showed a 94% efficacy against the Alpha variant in symptomatic infection following two doses, Reuters reported in February. The study looked at 1.2 million people.

Pfizer/BioNTech is working on boosters specifically against the new variants, Newsweek reported in late January. If any variants show resistance to the current vaccine, Pfizer said it wanted to be able to produce a booster “very, very quickly.”

A February study at the University of Texas revealed that the Pfizer vaccine provides substantial protection against the Beta variant, The Guardian reported. But a study from March indicated a reduced efficacy for Pfizer and Moderna against the Beta variant, The Hill reported. A study in the New England Journal of Medicine indicated the Pfizer vaccine was likely effective against the Zeta variant, Independent reported.

Delta Efficacy

The UK government announced in late June that both Pfizer and AstraZeneca are effective against hospitalizations from the Delta variant. The Pfizer vaccine was 96% effective against hospitalization and AstraZeneca was 92% effective (both after two doses.)

The Pfizer vaccine is less effective at preventing Delta’s spread than hoped, Israel’s Health Ministry reported on July 5, according to the Times of Israel. Data indicated Pfizer was still good at preventing hospitalization and severe cases, but its effectiveness at preventing symptomatic COVID was 64% compared to the 94.3% seen in May. However, a preprint funded by Pfizer and BioNTech on July 28 showed that the vaccine’s effectiveness slowly declined from 96.2% after two months to 84% over six months, The Hill reported. This was a study of 44,000 participants. Efficacy against severe disease was still at 97%.

In early August, the UK (Imperial College)’s latest REACT-1 data showed a lower real-world efficacy against infection after two vaccine doses than hoped (studying primarily Pfizer and AstraZeneca). The study didn’t differentiate results between vaccines, Reuters reported. (Although Moderna is now approved in the UK, it’s a more recent addition to the vaccine arsenal, Science Focus reported.)

The study estimated that two-dose vaccine effectiveness against the Delta variant is about 49%, increasing to 58% when only “strong positive” cases were counted. This is much lower than the effectiveness against earlier variants, which was about 90%. The study notes that the estimates “are lower than some others, but consistent with more recent data from Israel.”

A longer amount of time between COVID-19 mRNA vaccine doses might lead to more durable, long-lasting immunity, Axios reported in August 2021.  John Moore, a professor of microbiology and immunology at Cornell, said that a longer interval might give the immune system more time to mature.

A study comparing antibody levels discovered that Moderna generates double the antibodies of Pfizer, Bloomberg reported in September. It’s not yet clear how antibody levels transmit to efficacy, however. The study reviewed 1,600 health care workers in Belgium, with blood analyzed six and 10 weeks post-vaccination. The results might be due to the Moderna vaccine having 100 micrograms of its active ingredient compared to 30 micrograms in Pfizer.

Natural immunity from a prior SARS-CoV-2 infection brings greater immunity from Delta than two Pfizer doses, Science reported in September. The results were found in an Israeli study from June 1 to August 14, looking at tens of thousands of individuals while Delta was dominant. The study also indicated that a previous infection coupled with one Pfizer dose provided the best protection against reinfection.

NBC New York reported on September 10 that, according to a CDC study, fully vaccinated individuals accounted for 7% of hospitalizations and 8% of deaths from April 4-June 19. But after Delta became dominant, they accounted for 16% of COVID deaths and 14% of hospitalizations. This was a study of 13 jurisdictions that closely tracked these cases, with vaccination rates hitting 53% in the second timeframe. If vaccines had been 90% effective, then breakthrough cases should have accounted for 10% and not the 18% that was found.

The same study found that in those 13 jurisdictions, unvaccinated individuals still accounted for the majority of hospitalizations and deaths. Fully vaccinated people in Delta dominant regions were five times less likely to be infected, 10 times less likely to be hospitalized, and 10 times less likely to die.

Viral Load Studies & Transmitting the Virus

Pfizer’s vaccine reduces the viral load four-fold 12 to 28 days after the first dose, The Scientist reported in February. You can read the preprint here. However, these findings are related to earlier variants. Dr. Rochelle Walensky, director of the CDC, said in a statement on July 30: “High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus.”

Your Local Epidemiologist reported in early August that three studies indicated vaccinated individuals can spread the virus and carry the same viral load (with Delta predominant) as people who have not been vaccinated. The three studies are herehere, and here. Later studies confirmed this, reported Katelyn Jetelina. Vaccines still protect against hospitalization and death, but the viral load among the vaccinated and unvaccinated has been found to be the same in the first six days, with the viral load then declining faster in the vaccinated. A small study in the Netherlands found that 7 out of 10 vaccinated healthcare workers had an infectious level of the virus, while 8.5 out of 10 unvaccinated healthcare workers had an infectious level.

Long COVID

Breakthrough infections in the vaccinated population are about 50% less likely to lead to long haulers COVID, The Seattle Times reported in September. The study published in Lancet Infectious Diseases looked at data from 1.2 million adults who had received at least one dose of Pfizer, Moderna, or AstraZeneca from December 8 to July 4. (Meaning the study did not cover Delta cases only, but previous variants too.) Long COVID was defined as symptoms that lasted four weeks or more. The study involved only self-reported data.

Freezer Storage

In late February, the FDA approved the Pfizer vaccine for normal freezer storage (temperatures of -25°C to -15°C) for up to two weeks, Time reported.

BMI’s Effect on Doses

Italy researchers have proposed that people with a higher BMI may need a larger dose of the Pfizer vaccine, Independent reported in early March. The study looked at 158 females and 90 males, and saw that people with a higher BMI had a lower antibody response.

Pregnancy & Fertility

A preliminary peer-reviewed CDC report, published by The New England Journal of Medicine, indicated that Moderna and Pfizer are safe during pregnancy, CBS News reported. It covered the first 11 weeks of the vaccines’ rollout, ending on February 28. You can read the study here.

Scientific American spoke with four experts who shared that studies have shown COVID-19 vaccines don’t harm fertility or sexual function, although the virus itself might. The UK’s MHRA found that there’s no evidence of vaccines increasing the risk of birth defects or complications. A study of embryo transfers found that antibodies didn’t affect success rates. And while menstrual changes can occur after vaccination, they are temporary and likely due to physical stress, another expert said, much like exercise or being sick with a virus can also cause menstrual changes.

Heart Inflammation

The CDC’s advisers met in mid-June to discuss rare cases of heart inflammation following vaccination with mRNA vaccines Moderna and Pfizer, CBS News reported. The FDA added a warning about the rare heart inflammation side effect to Pfizer and Moderna vaccines, Reuters reported in late June. The CDC noted at that time that there were 309 hospitalizations for heart inflammation in people under 30, with 295 discharged. The cases were higher the week after the second dose, mostly in young men ages 12 to 24. The effect disappeared in ages 50 and older.

Long Haulers

A study from Israel found that about 3% of medical workers contracted COVID-19 after vaccination, USA Today reported in late July, and 19% of that 3% went on to have long COVID symptoms six weeks later. Most symptoms were mild.

TTP (Thrombocytopenic Purpura)

On June 24, The Jerusalem Post reported that Israeli researchers found that the Pfizer vaccine might be connected to a rare blood disorder called thrombotic thrombocytopenic purpura (TTP.) The research is still being evaluated, but indicated a “chronological connection” for both new patients and a flaring up of older cases following remission. The team is recommending that people with TTP only be vaccinated with their doctor’s permission.

Kidney & Skin Reactions

The European Medicines Agency is studying rare side effects reported for Pfizer and Moderna, but the FDA has said they have not seen any cases of those side effects, Reuters reported on August 11. The EMA is studying erythema multiforme (a skin reaction), glomerulonephritis (kidney inflammation), and nephrotic syndrome (a renal disorder) to see if they are possible side effects. The FDA said in a statement from spokesperson Abby Capobianco: “FDA is aware of the EMA report. To date, we have not seen any safety signals for the adverse events identified in the report.”


Moderna Updates (mRNA vaccine)

Moderna is one of the mRNA vaccines.

Efficacy Against Earlier Strains

Data released in mid-December 2020 showed that Moderna’s vaccine was highly protective against earlier strains, The New York Times reported. The vaccine had an efficacy of 94.1% in a trial with 30,000 participants. During trials, Moderna (and CanSino) both stopped giving high doses for the second dose because of the side effects, StatNews reported. Moderna’s current vaccine uses the lower dose for the second dose.

In mid-April, it was revealed that up to six months after the second dose, Moderna’s vaccine was 90% effective at preventing COVID-19 (for earlier variants than Delta) and more than 95% effective at preventing severe disease, CNBC reported. Moderna announced on January 25 that individuals who got the Moderna COVID-19 vaccine showed neutralizing antibody activity against the Alpha and Beta variants.

Efficacy Against Delta

The European Medicines Agency announced in mid-May that both Pfizer and Moderna appeared effective against the Delta variant (originally referred to as the India variant), Euro News reported. However, this information was later found to not be as accurate in real-world studies. Dr. Rochelle Walensky, director of the CDC, said in a statement on July 30: “High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus.”

Moderna is studying three booster candidates in a phase two trial of 50-microgram doses, CNBC reported. The data, submitted for peer review, reveals a robust antibody response to Delta after recipients received a booster. It’s not clear which of the three boosters showed the response.

The FDA authorized allowing people who are immunocompromised to get a third dose of Pfizer or Moderna, the two mRNA vaccines approved for use in the United States.

Moderna may have a lower Delta breakthrough risk than Pfizer, CNBC reported. A July Mayo Clinic study in Florida, which is still awaiting peer review, said the breakthrough risk for Moderna was about 60% lower than for Pfizer. The study authors also reported that in Minnesota, Moderna was 76% effective against infection versus Pfizer’s 47% efficacy. Both protect against severe disease.

Americans who received Pfizer and Moderna may be able to get a third booster shot as early as September 20 pending FDA approval, USA Today reported. The U.S. Department of Health and Human Services said Americans who received either vaccine will need a booster eight months later.

A longer amount of time between COVID-19 mRNA vaccine doses might lead to more durable, long-lasting immunity, Axios reported in August.  John Moore, a professor of microbiology and immunology at Cornell, said that a longer interval might give the immune system more time to mature.

A study comparing antibody levels discovered that Moderna generates double the antibodies of Pfizer, Bloomberg reported in September. It’s not yet clear how antibody levels transmit to efficacy, however. The study reviewed 1,600 health care workers in Belgium, with blood analyzed six and 10 weeks post-vaccination. The results might be due to the Moderna vaccine having 100 micrograms of its active ingredient compared to 30 micrograms in Pfizer.

Viral Load & Transmission of the Virus

Your Local Epidemiologist reported in early August that three studies indicated vaccinated individuals can spread the virus and carry the same viral load (with Delta predominant) as people who have not been vaccinated. The three studies are herehere, and here. Later studies continued to confirm this, reported Katelyn Jetelina in late August. Vaccines still protect against hospitalization and death, but the viral load among the vaccinated and unvaccinated has been found to be the same in the first six days, with the viral load then declining faster in the vaccinated. A small study in the Netherlands found that 7 out of 10 vaccinated healthcare workers had an infectious level of the virus, while 8.5 out of 10 unvaccinated healthcare workers had an infectious level.

Long COVID

Breakthrough infections in the vaccinated population are about 50% less likely to lead to long haulers COVID, The Seattle Times reported in September. The study published in Lancet Infectious Diseases looked at data from 1.2 million adults who had received at least one dose of Pfizer, Moderna, or AstraZeneca from December 8 to July 4. (Meaning the study did not cover Delta cases only, but previous variants too.) Long COVID was defined as symptoms that lasted four weeks or more. The study involved only self-reported data.

Refrigeration

Moderna said in early May that new data showed its vaccine is stable for up to three months if refrigerated, CNBC reported. The company was working on formulas to extend the shelf life more.

Full FDA Approval

Moderna is seeking full FDA approval as opposed to emergency use approval for its COVID-19 vaccine, Bloomberg reported. Pfizer applied for full approval on May 7.

Heart Inflammation

The FDA added a warning about a rare heart inflammation side effect to Pfizer and Moderna vaccines, Reuters reported in late June. The CDC noted at that time that there were 309 hospitalizations for heart inflammation in people under 30, with 295 discharged. The cases were higher the week after the second dose, mostly in young men ages 12 to 24. The effect disappeared in ages 50 and older.

The U.S. is reviewing whether Moderna has a 2.5 times higher chance of causing the side effect (although the overall chance is still rare), Reuters reported in August. Data from  Canada indicated the risk was especially higher for men younger than 30. An unnamed source from the FDA said it was too early to reach a conclusion, but the data was being investigated.

Kidney & Skin Reactions

The European Medicines Agency is studying rare side effects reported for Pfizer and Moderna, but the FDA has said they have not seen any cases of those side effects, Reuters reported on August 11. The EMA is studying erythema multiforme (a skin reaction), glomerulonephritis (kidney inflammation), and nephrotic syndrome (a renal disorder) to see if they are possible side effects. The FDA said in a statement from spokesperson Abby Capobianco: “FDA is aware of the EMA report. To date, we have not seen any safety signals for the adverse events identified in the report.”

Pregnancy & Fertility

A preliminary peer-reviewed CDC report, published by The New England Journal of Medicine, indicated that Moderna and Pfizer are safe during pregnancy, CBS News reported. It covered the first 11 weeks of the vaccines’ rollout, ending on February 28. You can read the study here. Moderna began a medical trial of 1,000 women that will last 21 months and will study the vaccine’s effects on pregnancy, UPI reported in mid-July. The trial will focus on pregnancy outcomes, complications, and infant outcomes.

Scientific American spoke with four experts in August 2021 who shared that studies have shown COVID-19 vaccines don’t harm fertility or sexual function, although the virus itself might. The UK’s MHRA found that there’s no evidence of vaccines increasing the risk of birth defects or complications. A study of embryo transfers found that antibodies didn’t affect success rates. And while menstrual changes can occur after vaccination, they are temporary and likely due to physical stress, another expert said, much like exercise or being sick with a virus can also cause menstrual changes.


Oxford/AstraZeneca Updates (Adenovirus vaccine)

The Oxford-AstraZeneca vaccine (called Covidshield in India) uses a chimpanzee-based adenovirus vector (ChAdOx1) to try to avoid pre-existing immunity in the human population. It is made from an adenovirus that was modified to help human cells create the spike protein so the immune system can recognize it, Nature reported.

Efficacy Against Earlier Variants

It is about 62% effective in people who got two full doses, BBC reported in late November. Another trial showed about 90% efficacy in 3,000 people who got a half-dose first and then a full dose the second time rather.

South Africa paused its AstraZeneca/Oxford vaccine rollout in early February after an analysis revealed the vaccine only provided minimal protection against the Beta (SA) variant, StatNews reported. A small study revealed that the AstraZeneca vaccine may only provide 10% protection against mild to moderate infections of the Beta variant, The Guardian reported.

AstraZeneca is showing a low efficacy against the B.1.351 variant, with a good efficacy against B.1.1.7, Your Local Epidemiologist reported. Efficacy against B.1.351 (from South Africa) was about 10 to 22% against mild-to-moderate disease. For B.1.1.7, it showed 74% efficacy.

Delta Efficacy

The UK (Imperial College)’s latest REACT-1 data shows a lower real-world efficacy against infection after two vaccine doses (focusing on Pfizer and AstraZeneca) than hoped. The study didn’t differentiate results between vaccines, Reuters reported. (Although Moderna is now approved in the UK, it’s a more recent addition to the vaccine arsenal, Science Focus reported.)

The study estimated that two-dose vaccine effectiveness against the Delta variant is about 49%, increasing to 58% when only “strong positive” cases were counted. This is much lower than the effectiveness against earlier variants, which was about 90%. The study notes that the estimates “are lower than some others, but consistent with more recent data from Israel.”

The UK government announced in late June that both Pfizer and AstraZeneca are effective against hospitalizations from the Delta variant. The Pfizer vaccine is 96% effective against hospitalization and AstraZeneca is 92% effective (both after two doses.)

AZ Testing with Sputnik V

AstraZeneca is testing a component of Russia’s Sputnik V vaccine in its clinical trials, according to a press release.

Long COVID

Breakthrough infections in the vaccinated population are about 50% less likely to lead to long haulers COVID, The Seattle Times reported in September. The study published in Lancet Infectious Diseases looked at data from 1.2 million adults who had received at least one dose of Pfizer, Moderna, or AstraZeneca from December 8 to July 4. (Meaning the study did not cover Delta cases only, but previous variants too.) Long COVID was defined as symptoms that lasted four weeks or more. The study involved only self-reported data.

Blood Clot Concerns

This vaccine faced a number of hurdles. In mid-March, many countries began pausing the vaccine after concerns about blood clots, CNBC reported. The Norwegian Medicine Agency noted a small number of cases of a rare blood clotting situation after getting the vaccine: a combination of low platelet blood count, bleeding, and blood clots in small and large blood vessels. This is called cerebral venous sinus thrombosis.

At first, WHO said it had found no links between the vaccine and blood clots, and  AstraZeneca also said there was no evidence of an increased blood clot risk. On Thursday, March 18, the European Medicines Agency (EMA) said that it didn’t increase overall blood clots, but acknowledged there was a possible connection to a rare type of clot. On April 4, the EMA’s safety committee concluded that rare blood clots should be listed as a rare side effect of AstraZeneca’s vaccine (now renamed Vaxzevria.) Symptoms include shortness of breath, chest pain, leg swelling, abdominal pain, persistent headaches or blurred vision, or tiny blood spots under the skin that are beyond the injection site.

Two groups of researchers in Norway and Germany believe they may have found the link between the AstraZeneca vaccine and blood clot issues, The Wall Street Journal reported in mid-March. The teams identified an antibody the vaccine creates which may trigger the rare blood clot reaction and could be treated in hospitals. The findings still need peer reviews.

On March 30, Canada suspended its use for anyone under 55, The Guardian reported. New data from Europe indicated the blood clot risk may be as high as one in 100,000. The rare blood clot typically occurs between four and 20 days after vaccination.

In the UK, most people under 40 will be offered an alternative to the AstraZeneca vaccine, such as Pfizer or Moderna, BBC reported in early May. So far there have been 242 rare clotting events and 49 deaths out of 28.5 million doses. However, the clot risk in the UK for people in their 30s was one in 60,000 and for people in their 40s, one in 100,000. Dr. June Raine, chief executive of the MHRA, said that the benefits are still greater than the risks for older demographics, but the benefits versus risks for younger demographics are “more finely balanced.”

German scientists reported that they believe they can improve AstraZeneca and Johnson & Johnson vaccines to avoid blood clots, The Guardian reported. Rolf Marschalek, a professor at Goethe University, developed the solution with a team of colleagues. The team released the findings in a preprint still awaiting peer review, which you can read here.

Other Issues

The EMA is also investigating capillary leak syndrome after five cases were reported following the AstraZeneca vaccine.

Another issue cropped up later in March. AstraZeneca had announced that its vaccine was 79% effective in a U.S. trial of 30,000 volunteers, but the National Institute for Allergy and Infectious Diseases issued a statement of concern that the results were incomplete, Bloomberg reported on March 23. Fauci said there is concern that trial data was outdated and might be “misleading.” AstraZeneca responded that the numbers were based on interim analysis and they would update the numbers in a couple of days. On Facebook, Your Local Epidemiologist noted that it was “highly unusual for the Data Safety and Monitoring Board (DSMB) and a vaccine sponsor (AstraZeneca) to publicly (or privately in that matter) disagree.”

Countries’ Slow Roll-Out

In June, Canada announced that people who got AstraZeneca as their first dose could get Pfizer or Moderna for their second.

Germany also announced that it would stop giving the AstraZeneca vaccine to anyone under 60 unless they’re in a high-risk category for getting severe COVID-19, ABC News reported on March 30. In May, they changed their mind and said anyone 18 or older could get the vaccine.

The Netherlands suspended the AstraZeneca vaccine for people under 60, Reuters reported. Australia advised people under 50 to get the Pfizer vaccine and not AstraZeneca as of early April, ABC.net reported. In June, the country clarified that only people over 60 should get the AZ vaccine.

The EU Commission won’t renew its contracts for vaccines using the viral vector, including J&J and AstraZeneca vaccines, Reuters reported in mid-April.

Thailand is going to use AstraZeneca’s vaccine as a booster shot for people who received China’s Sinovac, Reuters reported in mid-July.


Russia’s Sputnik Vaccine Updates (Adenovirus Vector Vaccine)

Russia’s Sputnik V vaccine is an adenovirus vector vaccine using Ad26 as its first dose and Ad5 for its second. It differs from other adenovirus vector vaccines like J&J and AstraZeneca because it uses two adenovirus vectors rather than one as a means of increasing efficacy.

Efficacy Against Earlier Variants

Russia’s Sputnik vaccine was reported to be 91.6% effective against symptomatic COVID-19 and 100% effective against moderate and severe cases when reviewed against earlier variants, CNN reported in early February. This was reported in interim Phase 3 trials and published in The Lancet. People over age 60 showed a 91.8% efficacy. Serious reactions were rare, and most side effects included mild-flu like symptoms, pain at the injection, and low energy. Some researchers criticized the study for not providing access to raw data.

Fauci said in late March that data on Russia’s Sputnik V Vaccine indicates it’s “quite effective” and “looks pretty good,” Bloomberg reported. He had previously said he was skeptical of the vaccine when Russia approved it before Phase 3 trials.

Moscow’s Gamaleya Institute and the Russian Direct Investment Fund announced in mid-April that a real-world study showed the Sputnik V vaccine is 97.6% effective, higher than reported in the initial trial, Reuters reported. The results were calculated after the second booster dose, about 35 days after the first injection.

Russia approved a one-dose version of its Sputnik V vaccine called Sputnik Light in early May, The Straits Times reported. The two-dose version had 91.6% efficacy compared to 79.4% for the one-dose version after 28 days. (This was against earlier variants.)

Argentina researchers found that Russia’s Sputnik V vaccine was effective against the Gamma variant, Reuters reported.

Efficacy Against Delta

The Russian Health Minister has said that Sputnik V is 83% effective against the Delta variant, India Today reported. It has 95% efficacy against severe illness. The 83% efficacy is lower than the original 90% estimate, Reuters reported.

Alcohol

Russians who receive the Sputnik V coronavirus vaccine are being asked not to drink alcohol for two months after, the New York Post reported. This is the amount of time they said it takes the vaccine to be effective and alcohol can be a strain on the body’s immune response, the experts said.

Shipments to Other Countries

In mid-February, the first 100,000 doses of the Sputnik vaccine arrived in Venezuela, Yahoo News reported. On February 23, AP reported that Mexico received its first shipment of the Sputnik vaccine: 200,000 doses. A committee of experts recommended Sputnik V’s use in India, NDTV reported on April 12.

The vaccine is now used in nearly 70 countries, Nature reported in early July. These include Brazil, Hungary, India, and the Philippines. However, it has not received emergency approval from WHO or the European Medicines Agency.

Blood Clots & Defamation Lawsuit

The Gamaleya Center announced in mid-April that Russia’s Sputnik V vaccine did not show signs of CVST in its clinical trials. (The Gamelaya Center is a research institution in Russia that developed Sputnik V.) The Gamaleya Center proposed several ideas for why it has not yet shown the blood clot issue, writing:

Sputnik V is a two-component vaccine in which adenovirus serotypes 5 and 26 are used. A fragment of tissue-type plasminogen activator is not used, and the antigen insert is an unmodified full-length S-protein. Sputnik V vaccine is produced with the HEK293 cell line, which has long been safely used for the production of biotechnological products.Thus, all of the above vaccines based on adenoviral vectors have significant differences in their structure and production technology. Therefore, there is no reason and no justification to extrapolate safety data from one vaccine to safety data from other vaccines.The quality and safety of Sputnik V are, among other things, assured by the fact that, unlike other vaccines, it uses a 4-stage purification technology that includes two stages of chromatography and two stages of tangential flow filtration.

Nature confirmed this in July, noting that Sputnik does not appear to have the rare blood-clotting side effect seen in J&J or AstraZeneca. Some scientists argue, however, that Russia’s adverse-event monitoring might be less rigorous. However, Argentina also did not report any clotting side effects after four million doses. Neither has Serbia.

Brazil’s regulatory authority turned down emergency use authorization for the Sputnik V vaccine from Russia after Anvisa, Brazil’s drug agency, said that data indicated it had a “replication-competent” adenovirus, Science Mag reported in late April. However, the Gamaleya Institute disputed the findings and threatened a defamation lawsuit in response. Others have debated if Anvisa is interpreting Sputnik’s data correctly, Science Mag reported.


Novavax Updates

Novavax is not an mRNA vaccine, ScienceMag reported. Instead, Novavax is using a baculovirus to insert a gene for the spike protein, harvesting the spike proteins and using that in an adjuvant.

Your Local Epidemiologist shared that Novavax’s vaccine is different from the others available in the U.S. This one “contains a coronavirus protein that prompts the immune system,” which is combined with an immune-boosting adjuvant from the soapbark tree. The vaccine was made in moth cells, rather than mammal cells, allowing Novavax to manufacture the vaccine faster.

On August 4, the European Commission approved a contract to buy 200 million doses, Reuters reported.

Efficacy Against Earlier Variants

In mid-February, FT reported that Novavax was about to finish its U.S. trial of the vaccine in record time, having enrolled 30,000 participants since beginning the trial in late December. A UK trial of the two-shot vaccine found it 85.6% effective against Alpha variant and 95.6% effective against the original strain.

Novavax showed 49% efficacy in HIV+ and HIV- participants in South Africa. A placebo group showed no protection against B.1.351 variant (Beta originating in SA.)

Recent Phase 3 trials showed positive results for Novavax’s COVID-19 vaccine, NBC News reported in mid-June. The trial showed an overall efficacy of 90.4% (77 cases of COVID-19 were found in the placebo group and 14 in the vaccine group with nearly 30,000 participants.) The vaccine group cases were mild, indicating 100% effectiveness against moderate to severe illness. The company will apply for FDA authorization in the third quarter based on the results. 

Flu/COVID Vaccine Version

Novavax is beginning an early-stage trial in Australia of a flu/COVID vaccine combo, NBC News reported. The first trial studies 640 adults from ages 50 to 70 who either had a COVID vaccine at least eight weeks before the study or were infected. They’ll get a shot that combines NVC-CoV2373 and NanoFlu with an adjuvant.


Inovio Updates

Inovio’s vaccine is called the INO-4800 DNA vaccine. Inovio announced positive results from two Phase I clinical trials in early July 2020. The Phase 1 trial was expanded to include older participants in June and July 2020. This is a nucleic-based vaccine that will be stable at room temperature for more than a year and doesn’t need to be frozen.

On January 4, 2021, Inovio said it expected to begin a late-stage study of its vaccine in the U.S. in the second quarter of 2021 after finishing mid-stage trials in March, Reuters reported. The vaccine has three mid-stage trials, one in the U.S., one in China with Advaccinek, and one in South Korea. The U.S. Phase III trial had been delayed as the FDA requested more information on the delivery device.

On February 12, Inovio shares traded higher, Seeking Alpha reported. Analyst Hartaj Singh believed Inovio’s vaccine showed promise, noting: “We believe the overall DNA platform by INO should not be overlooked.”


Johnson & Johnson Updates (Adenovirus Vector Vaccine)

Johnson & Johnson’s vaccine is an adenovirus vector vaccine using an Ad26 vector (a human adenovirus) believed to have less natural immunity in the human population.

Efficacy Against Earlier Variants

Data related to Johnson & Johnson’s vaccine showed 66% overall effectiveness in February 2021: 57% in South Africa (rising to 64% after about a month), 66% in Latin America, and 72% in the United States, CNBC reported. The vaccine group reported no deaths, while the placebo group reported seven deaths. People ages 60 and older with comorbidities had a lower efficacy rate of about 42.3%. You can read the 62-page FDA briefing document from Johnson & Johnson here.

Following approval in the United States, Canada approved Johnson & Johnson’s vaccine, CBC reported. In the UK, Janssen’s vaccine was approved in late May.

Johnson & Johnson said it would be working on new COVID-19 vaccines that would be effective against variants, Reuters reported in mid-March.

A real-world trial of Mayo Clinic patients from February 27 to April 14 revealed 76.7% efficacy for the Johnson & Johnson vaccine, according to an April 30 study.

Efficacy Against Delta

Johnson & Johnson’s vaccine shows that it generates an antibody response against the Delta variant in a study of eight individuals, NPR reported in early July. This is in a preprint. The preprint noted: “The Janssen COVID-19 vaccine efficacy (VE) against the Delta variant of concern is currently unknown and may become available from our ongoing phase 3 trials only later this year.” Your Local Epidemiologist explained that the study found a 1.6-fold decrease in neutralizing antibodies, which can’t be directly mapped to real-world efficacy, but a mathematical model predicts it might be 55 to 60% against symptomatic disease.

Dr. Rochelle Walensky, director of the CDC, said in a statement on July 30 about all approved vaccines: “High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus.”

A Sisonke study from a South African trial of 480,000 healthcare workers revealed that Johnson & Johnson’s vaccine provided 71% protection against hospitalization from Delta, Gothamist reported. This was similar to what was reported in U.S. clinical trials. Protection was at 67% against the Beta variant.

About 96% of breakthrough infections from February through July 16 were mild, with less than 0.5% resulting in severe cases or death.

Johnson & Johnson is reporting a robust immune response with a booster of its one-shot vaccine, CNN reported in late August. Receiving a booster six to eight months after an initial vaccination increased antibodies nine-fold as compared to 28 days after the first shot. The study looked at 2,000 people in the U.S. and Europe. The study does not review real-world efficacy. NIAID is running a small trial that looks at how J&J, Pfizer, and Moderna recipients react to a Moderna booster.

Blood Clots

On April 9, 2021, EMA announced that it was investigating if Johnson & Johnson’s vaccine might have any correlation with rare blood clot events found in AstraZeneca, called cerebral venous sinus thrombosis. The FDA and CDC paused the J&J vaccine while investigating CVST on April 13. Fifteen people in the U.S. had developed a rare clotting condition — cerebral venous sinus thrombosis out of about 8 million doses, as of late April. One was a healthy 25-year-old man who had a cerebral hemorrhage, The New York Post reportedthe only case not in a woman ages 18-59. On April 25, the CDC recommended that use of the vaccine resume. The CDC noted that women under 50 should be aware of the rare but increased blood clot risk.

The Australian government announced that it won’t use the Johnson & Johnson vaccine in its rollout, because of the similarities to the AstraZeneca vaccine, UPI reported.

The EU Commission won’t renew its contracts for vaccines using the viral vector, including J&J and AstraZeneca vaccines, Reuters reported in mid-April.

German scientists reported that they believe they can improve AstraZeneca and Johnson & Johnson vaccines to avoid blood clots, The Guardian reported. Rolf Marschalek, a professor at Goethe University, developed the solution with a team of colleagues. The team released the findings in a preprint still awaiting peer review, which you can read here.

Guillain-Barre Syndrome

The FDA has added a warning to the Johnson & Johnson vaccine about a rare Guillain-Barre syndrome side effect, the New York Times reported in mid-July 2021. The chances are still low, but three to five times higher for vaccine recipients than the general population.

Dizziness, Tinnitus, & Immune Thrombocytopenia

The EMA recommended that three new rare conditions be added to Johnson & Johnson’s label as potential adverse reactions, including immune thrombocytopenia, dizziness, and tinnitus.


CureVac updates

In February 2021, EMA began a rolling review of CureVac’s vaccine, CVnCoV, EMA reported. CureVac is conducting clinical trials on safety, immune response, and effectiveness. CureVac utilizes the mRNA vaccination method.

On February 25, CureVac announced that preliminary animal trials showed it was effective against UK and SA variants, Reuters reported.

On March 4, CureVac and Novartis signed a manufacturing agreement for the second quarter of 2021, with the hope of having 50 million doses available by the end of 2021 and 200 million in 2022. Manufacturing would take place in Austria.

CureVac is now expanding late-stage clinical trials as of late March, BioPharma reported. The trials will look at efficacy against UK, SA, and Brazil variants. Phase 1 data showed strong antibody responses and T cell activation.

CureVac’s clinical trial of 40,000 volunteers in Latina America and Europe showed just a 47% efficacy in mid-June, The New York Times reported. The German company will still apply for approval with the European Medicines Agency, but some experts believe variants are to blame for the poor results compared to earlier trials. CureVac’s CVnCoV is also an mRNA-based vaccine.

Final trial results were also disappointing, The New York Times reported on June 30. It showed an overall efficacy of 48%. Efficacy was 53% in ages 18-60, with 100% protection against hospitalization and death.


Sanofi and GlaxoSmithKline Updates

Sanofi and GlaxoSmithKline vaccine early trials were disappointing, The New York Times reported in mid-December. The vaccines didn’t produce a good immune response in older participants, although they did in people under 50.


China/Sinovac’s CoronaVac Vaccine Updates

The vaccine uses an inactivated SARS-CoV-2 virus.

Earlier Variants

One study in March 2021 called into doubt whether Sinovac’s CoronaVac vaccine will trigger enough protection against the Gamma (Brazil) variant, Reuters reported. This was based on plasma samples from eight people, which didn’t effectively neutralize the variant.

Meanwhile, Turkish trials showed China’s Sinovac vaccine was 83.5% effective, and 100% effective in preventing hospitalization, Bloomberg reported. Officials in Brazil said it was 50.38% effective in preventing cases.

Indonesia reported that China’s Sinovac vaccine protected 98% of healthcare workers from death and 96% from hospitalization, Yahoo! Finance reported on May 12. About 94% of the 128,290 health care workers were also protected from symptomatic infection, the January-March study found. This differs greatly from a Phase III trial in Brazil that showed efficacy at about 50%.

Indonesia Health Minister Budi Gunadi Sadikin said that after tracking 25,374 healthcare workers who received the vaccine in Jakarta, they found that Sinovac protected 94% from infection and 96% from hospitalization, SCMP reported. It’s not known if they were screened for asymptomatic infection.

Sadikin said they saw a “drastic drop” in hospitalizations and deaths among vaccinated healthcare workers. In Chile, 89% of people vaccinated with CoronaVac were protected from serious COVID-19 complications.

Thailand is going to use AstraZeneca’s vaccine as a booster shot for people who received China’s Sinovac, Reuters reported in mid-July.


China’s CanSino Biologics’ Vaccine (Adenovirus Vector)

Earlier Variants

China’s CanSino Biologics revealed that its coronavirus vaccine had 65.7% efficacy at preventing symptomatic cases and 90.8% effective in preventing severe disease, Bloomberg reported on February 8, 2021. The one-shot vaccine is developed by the biologics company and the Chinese military. This adenovirus vector vaccine was the first to start clinical trials in the world, but a trial in North America was indefinitely delayed.

The vaccine received emergency use approval in Hungary on March 22, Reuters reported. It was also approved in China, Pakistan, and Mexico.

China’s CanSino Biologics has also obtained approval to start clinical trials of an inhaled version of the COVID-19 vaccine using an Adenovirus Type 5 vector, Global Times reported in late March. The vaccine is the same as the already approved single-dose vaccine, only using an “atomization inhalation device.”


Covaxin & Covishield Updates from India

The vaccine uses an inactivated SARS-CoV-2 virus.

Covaxin, a vaccine from India created by Bharat Biotech International and the Indian Council of Medical Research, showed an efficacy of 81% after two doses in early Phase 3 data, but whether this applied to mild symptoms or severe cases isn’t known, Bloomberg reported. This data was based on 36 cases of COVID-19 in a placebo group versus seven cases in a vaccinated group. The vaccine came under criticism when it was rolled out in India before Phase 3 trial data was available.

On March 4, Zimbabwe announced that it had approved the vaccine for use, making it the first country in Africa to authorize the vaccine.

A preprint study submitted to The Lancet indicates that India’s Covishield may have an overall 63% efficacy and 81% efficacy against severe disease in those who are fully vaccinated, Deccan Herald reported. This was reported during the Delta variant’s second wave.


Zoetis Animal Vaccine Updates

The San Diego Zoo vaccinated nine great apes (four orangutans and five bonobos) using an experimental COVID-19 vaccine, The San Diego Union-Tribune reported. They’re planning to vaccinate three more bonobos and a gorilla. The apes were given two doses in January and February, spaced by three weeks. They voluntarily sat down for the injections, which weren’t forced. No visible side effects have been noted, except a few rubbed their head or the injection site.

Zoetis, which was once part of Pfizer, is developing the COVID-19 vaccine for animals. It delivers a piece of the surface protein, similar to how Novavax works. The doses aren’t authorized for people.

The vaccine will soon be trialed in a formulation developed for minks, The Guardian reported in late March. A vaccine among minks might help slow down the emergence of variants that could infect the human population.


Oravax Medical’s Oral Vaccine Updates

Oramed Pharmaceuticals, an Israeli-American pharmaceutical company, is working with India’s Premas Biotech to develop a vaccine by a new company called Oravax Medical. This would be an oral vaccine that could be taken at home, The Jerusalem Post reported in late March. Phase 1 trial data could be available within three months. The vaccine targets three structural proteins rather than one spike protein, and the company believes it may be more resistant to variants.


China’s Sinopharm Vaccine Updates

On May 7, 2021, WHO gave emergency approval to China’s vaccine made by Sinopharm, Channel News Asia reported. This was the first time WHO gave emergency approval to any Chinese infectious disease vaccine, and the first non-Western country to receive WHO approval for a COVID-19 vaccine. This is another vaccine using an inactivated virus.

Sinopharm announced December 30 that it was 79% effective, but the United Arab Emirates said it was 86% effective in January. A Phase III clinical trial revealed 78.1% efficacy, Channel News Asia reported. It’s not clear where efficacy stands against Delta.

The Argentine Ministry of Health found in mid-July that China’s Sinopharm vaccine is 84% effective in preventing death in peoples ages 60 and over after two doses, The Straits Times reported.


QazVac Vaccine Updates

Kazakhstan began rolling out a new vaccine called QazVac (originally called QazCovid-in), Fortune reported on April 27, 2021. The vaccine was developed within Kazakhstan and researchers claim it has 96% efficacy in Phase 2 trials. Phase 3 trials will end in July, but regulators already approved a rollout of the vaccine. This is a more traditional vaccine that, like India’s Covaxin and China’s CoronaVac, uses an inactivated SARS-CoV-2 virus. It requires two doses, three weeks apart.


Cuba’s Abdala Vaccine

Cuba’s Abdala vaccine was 92.28% effective in clinical trials, Reuters reported in late June. This vaccine requires three doses as opposed to the two-dose regimens more commonly seen in other regions. The country’s other vaccine, Soberana 2, was 62% effective after the second of three doses. MarketWatch reported that Cuba did not release any details about the vaccine testing.


ImmunityBio Oral Vaccine Updates

At Chan Soon-Shiong Research Institute in El Segundo, California, researchers from ImmunityBio are testing an oral COVID-19 vaccine, CBS News reported in early April. It’s being tested on healthy volunteers using four approaches, including some people getting both the pill and a vaccine shot. The pill targets creating T cells that react to a globe in the middle of the virus that’s less prone to mutation, while current vaccines create antibodies to the spike protein. The trial is available to people who are 55 or younger, haven’t had COVID, and aren’t pregnant.


ZyCoV-D

ZyCoV-D is a DNA-based vaccine from India. In August 2021, India gave emergency use authorization to ZyCoV-D by Zydus Cadila, a three-dose vaccine, LiveMint reported. The vaccine is approved for children above 12 and adults. In July, an efficacy of 66.6% was shown for a trial of more than 28,000 volunteers. The shot uses a needle-free applicator.

ZyCoV-D is the first DNA plasmid-based vaccine, Yahoo! News reported. It uses a DNA plasma vector. One study noted: “We developed a candidate vaccine ZyCoV-D comprising of a DNA plasmid vector carrying the gene encoding the spike protein (S) of the SARS-CoV-2 virus.”

In describing this new type of vaccine, an early study wrote:

The conventional active vaccines are made of a killed or attenuated form of the infectious agent. Vaccination with live attenuated and killed vaccines in most cases results in generation of humoral but not a cell-mediated immune response. What is required in such cases, but not available, are antigens that are safe to use, that can be processed by the endogenous pathway and eventually activating both B and T cell response. The activated lymphocytes generated would destroy the pathogen-infected cell. For these reasons, a new approach of vaccination that involves the injection of a piece of DNA that contains the genes for the antigens of interest are under investigation. DNA vaccines are attractive because they ensure appropriate folding of the polypeptide, produce the antigen over long periods, and do not require adjuvants…

Finally, DNA vaccines have been shown to persist and stimulate sustained immune responses. Other advantages are that the technology for producing the vaccine is very simple and rapid, secondly the DNA molecule is stable, has a long shelf life, and does not require a strict cold chain for distribution. DNA vaccines are also safer than certain live-virus vaccines, especially in immunocompromised patients. It also circumvents the numerous problems associated with other vaccines, such as immune responses against the delivery vector and concern about safety related to the use of any viral vector.

This is the first DNA-based vaccine approved for human use.


Other Adenovirus Vaccines

ImmunityBio is developing an adenovirus-vector vaccine based on Ad5. They are conducting a trial using a combination of an oral vaccine and an under-the-tongue vaccine. Some hope that Ad5 delivered this way might have less of an issue with pre-existing immunity in the population.

Altimmune, Stabilitech BioPharma, and Vaxar are testing Ad5 vaccines using nasal sprays or pills, CEN reported. Altimmune’s AdCOVID is adenovirus-based but is delivered intranasally. On March 15, the results from a transgenic mouse model were announced from a preclinical trial.

ReiThera (once called Okairos) is testing a COVID-19 vaccine using a gorilla-derived adenovirus vector, CEN reported. This GRAd-COV2 vaccine candidate just started its Phase 2/3 clinical study on March 18. The study is named COVITAR.

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